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    Impella catheters - Intravascular micro axial blood pumps that support a patient's circulatory system. (1) Product Code 005042 - Impella 2.5 (2) Product Code 005062 - Impella 5.0 (3) Product Code 005082- Impella LD (7) Product Codes 0550-0008 and 1000100 - Impella 5.5 with SmartAssist (8) Product Code 0048-0032 - Impella CP (9) Product Codes 1000080 and 0048-0045 - Impella CP with SmartAssist ***Updated February 2024*** (10) 004413 - Impella 2.5 Set (12) 0046-0026 - Impella 5.0 Pump Set ROW (13) 0046-0037 - Impella 5.0 Pump Set APAC (15) 004680-AU - 5.0 Pump Set AU (16) 0048-0002 - Impella CP Pump Set, EU (17) 0048-0002-BR - Impella CP Pump Set BR (18) 0048-0004 - Impella CP Pump Set, Canada (19) 0048-0014 - Impella CP Smart Assist Set, EU (20) 0048-0024-JP - Impella CP Smart Assist Set, JP (21) 0048-0044 - Impella CP Smart Assist Set, Canada (22) 0048-0047 - Impella CP Smart Assist Set APAC (23) 005040 - Impella 2.5 IMC Pump Set EU (24) 005048-JP - Impella 2.5 Pump Set, Japan (25) 005060 - Impella 5.0 IMC Pump Set EU (26) 005064 - Impella 5.0 IMC Pump Set Canada (27) 005066-JP - Impella 5.0 Pump Set, Japan (28) 0550-0002 - Impella 5.5 with SmartAssist Set, EU (29) 0550-0004 - Impella 5.5 with SmartAssist Set, CA (30) 1000115 - Impella CP Pump set, APAC (31) 1000211 - Impella 5.5 SmartAssist Set, JP (32) 1000302 - Impella CP with SmartAssist APAC (33) 1000361 - Impella 5.5 Set AU (34) 1000402 - Impella CP Smart Assist Set ***Updated March 15, 2024*** The following products were removed from the list of affected products because the Right-side devices are not in the scope of the warning to avoid left ventricle perforation: (4) Product Code 004334 - Impella RP (5) Product Code 0046-0035 - Impella RP with SmartAssist (6) Product Code 1000323 - RP Flex with SmartAssist (11) 0046-0011 - Impella RP Pump Set, EU (14) 0046-0039 - Impella RP Set APAC

    FDA Enforcement
    Class I ·Ongoing·Abiomed, Inc.·February 21, 2024

    Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO IMC (5PK), REF H749085262032; cardiac catheter

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·May 22, 2024

    Description/REF: ACCESS TRAY/GU-04020; PSI KIT: 8.5 FR/AK-09803-CDC; PSI KIT: 9 FR/AK-09903-CDC; PSI KIT: 8.5 FR X 4 IN (10 CM)/ASK-09810-PCMH1; PSI KIT: 9 FR X 10 CM/ASK-09903-KH; PSI KIT: 9 FR X 10 CM/ASK-09903-PHP1; PSI KIT: 9 FR X 4 IN (10 CM)/ASK-09903-UPA; PSI KIT: 9 FR X 4 1/8 IN (10 CM)/ASK-09903-YNH; PSI KIT: 9 FR X 4 1/8 IN (10 CM)/ASK-09907-SL; PSI KIT: 8.5 FR X 4-1/8IN (10 CM)/NA-09803-CDC; PSI KIT: 9 FR X 4-1/8IN (10 CM)/NA-09903-CDC; PSI KIT: 9 FR X 4 IN (10 CM)/ASK-09903-ECL4; PSI KIT: 9 FR X 4 1/8 IN (10 CM)/ASK-09903-MGH3; MULTI-LUMEN/PSI KIT/AK-11142-SPCS; MAC KIT: 2-L 9 FR DISTAL X 11.5 CM/CDC-11242-1A; MULTI-LUMEN/PSI KIT/AK-11142-D; MULTILUMEN/PSI KIT: 9 FR X 4 IN (10 CM)/ASK-11142-MGH4; MULTI-LUMEN/PSI KIT/NA-11242-CDC; MULTI-LUMEN/PSI KIT/AK-21142-SK; MAC KIT: 2L 9 FR DISTAL X 10 CM AGB/ASK-21142-LMDTG; MULTI LUMEN/PSI KIT: 9 FR X 4 IN (10 CM)/ASK-21142-RH; MULTILUMEN/PSI KIT 9 FR X 11.5 CM/ASK-21242-IMC; MAC KIT: 2L 9 FR DISTAL X 11.5 CM AGB/ASK-21242-LMDTG; MAC KIT: 2L 9 FR DISTAL X 11.5 CM/ASK-21242-UMD; MAC KIT: 2L 9 FR DISTAL X 11.5 CM/ASK-21242-UU3; MAC KIT: 2L 9 FR DISTAL X 11.5 CM/ASK-21242-VCU; MAC KIT: 2L 9 FR DISTAL X 11.5 CM AGB/CDC-21242-1A; MAC KIT: 2L 9 FR DISTAL X 11.5 CM AGB/CDC-21242-X1A; MULTI-LUMEN/PSI KIT/AK-21242-CDC; 2L MAC KIT: 9 FR DISTAL X 4 IN (10 CM)/ASK-21142-FH4; MULTI LUMEN/PSI KIT: 9 FR X 4 IN (10 CM)/ASK-21142-GH1; 2L MAC KIT: 9 FR DISTAL X 4 IN (10 CM)/ASK-21142-SUU; 2-L MAC KIT: 9 FR DISTAL X 4 IN (10 CM)/ASK-21142-UPMC4; MAC KIT: 2L 9 FR DISTAL X 11.5 CM/ASK-21242-UKL; MAC KIT: 2L 9 FR DISTAL X 11.5 CM/ASK-21242-UMF; MULTILUMEN/PSI KIT: 9 FR X 4 1/2 IN/ASK-21242-UR1; PSI KIT: 8.5 FR/AK-29803-CDC; PSI KIT: 9 FR/AK-29903-CDC; PSI KIT: 9 FR/AK-29907-CDC; PSI KIT: 8.5 FR X 4IN (10 CM)/ASK-09804-UN1; PSI KIT: 9 FR/ASK-09903-UM; PSI KIT: 8.5 FR X 10 CM ANTIMICROBIAL/ASK-29803-LMDT; PSI KIT: 8.5 FR X 10 CM ANTIMICROBIAL/ASK-29803-LMDTG; PSI KIT: 9 FR X 4 1/8 (10 CM)/ASK-29903-BID1; PSI KIT: 9 FR X 10 CM ANTIMICROBIAL/ASK-29903-LMDTG; PSI KIT: 9 FR X 10 CM ANTIMICROBIAL/ASK-29903-UMD; PSI KIT: 9 FR X 4 IN (10 CM)/ASK-29903-UR1; PSI KIT: 8.5 FR X 10 CM ANTIMICROBIAL/CDC-29803-X1A; PSI KIT: 8.5 FR X 10 CM/ASK-29803-ECL; PSI KIT: 8.5 FR X 4 IN (10 CM)/ASK-29803-UPM3; PSI KIT: 9 FR X 10 CM/ASK-29903-ECL; PSI KIT: 9FR X 4IN (10 CM) ANTIMICROBIAL/ASK-29903-UPM3; PSI KIT: 9 FR X 4 IN (10 CM)/ASK-09907-TG1

    FDA Enforcement
    Class I ·Ongoing·ARROW INTERNATIONAL, LLC·June 24, 2026

    Purge Cassette, sold within Impella Pump Sets and Individually Packaged. Labeled and distributed in the below configurations and corresponding product codes. 1. Purge Cassette, 5 Pack; Product Code: 0043-0003. 2. Impella RP US Pump Set; Product Code: 004334. 3. Purge Cassette, Packaged; Product Code: 0043-0002. Also included inside Product Code 0043-0003 above. Product Code 0043-0002 also includes innermost packaged product with Product Code 0043-0001. 4. Impella 2.5 Set; Product Code: 004413 (Customer facing code 005040). 5. Impella RP Pump Set, EU; Product Code: 0046-0011. 6. Impella CP Pump Set, EU; Product Code: 0048-0002. 7. Impella CP Pump Set BR; Product Code: 0048-0002-BR. 8. Impella CP Smart Assist Set, EU; Product Code: 0048-0014 (Also inclusive of codes 0048-0047 and 1000402 listed below). 9. Impella CP Smart Assist Set, Canada; Product Code: 0048-0044. 10. Impella CP Smart Assist Set APAC; Product Code: 0048-0047 (inclusive under code 0048-0014). 11. Impella 5.0 IMC Pump Set EU; Product Code: 005060. 12. Impella 5.5 with SmartAssist Set, EU; Product Code: 0550-0002. 13. Impella 5.5 with SmartAssist Set, CA; Product Code: 0550-0004. 14. 5.5 Accessories AU; Product Code: 1000362. 15. Impella CP Smart Assist Set; Product Code: 1000402 (inclusive under code 0048-0014).

    FDA Enforcement
    Class I ·Ongoing·Abiomed, Inc.·April 8, 2026

    ANGIODRAPE PACK - - (1) GUIDEWIRE 0.035" X 150cm (2) SYRINGE 10ccWITHOUT NEEDLE LUER LOCK UF (2) Pr. SURGICAL GLOVES #8 (2) GOWN STANDARD LARGE SMS VELCRO NECK (2) NEEDLE HYPODERMIC 21G X 1 W' UF (1) TABLE COVER 44" X 90" (3) CLOTH HUCK TOWELS BLUE (2) UTILITY BOWL 16oz L/F (1) SOLUTION SURGICAL DURAPREP 26ML UF (3) DRAPE UTILITY WITH TAPE UF (3) TOWEL CLAMP (2) TOWELS ABSORBENT 15" X 20" UF (1) NEEDLE 18G X 2% AMC/4 (1) FEMORAL ANGlO DRAPE WITH POUCH UF (1) BAND BAG RUBBAND & TAPE UF (1) CUP DENTURE WITH LID (30) GAUZE SPONGE 4" X 4" 12PL Y (2) TIP ASBORBENT APPLICATOR STICK SPONGE (1) SCALPEL WITH HANDLE #11 (1) STOPCOCK 3 WAY (1) SYRINGE 30cc WITHOUT NEEDLE LUER LOCK L/F (1) SYRINGE 30cc WITHOUT NEEDLE LUER LOCK L/F EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents

    FDA Enforcement
    Class I ·Terminated·Customed, Inc·September 10, 2014

    ANGIOGRAPHY PACK - ( 1) FEMORAL ANGlO. DRAPE WITH POUCH (2) SYRINGE 10cc W/0 NEEDLE LUER LOCK LIF (2) NEEDLE HYPODERMIC 21G X 1% ( 1) TABLE COVER REINFORCED 44" X 78" LIF (30) GAUZE SPONGES 4" X 4" 12PLY ( 1) GOWN IMPERVIOUS REINFORCED LARGE SMS ( 1) GOWN LARGE NON REINFORCED SMS TOWEL & WRAP ( 1) GUIDEWIRE .035" X 150cm MOVABLE (2) BAND BAG RUBBAND & TAPE L/F (2) DENTURE CUP 8oz. WITH LID ( 1) SYRINGE 3cc WITHOUT NEEDLE LUER LOCK LIF ( 1) NEEDLE HYPODERMIC 18G X 1 % ( 1) SYRINGE 30cc WITHOUT NEEDLE LUER LOCK L/F (4) DRAPE UTILITY WITH TAPE L/F (2) SOLUTION SURGICAL DURAREP 6ml L/F (2) TOWEL CLAMP (1) NEEDLE 18G X 2% AMC/4 (4) TOWELS CLOTH HUCK BLUE ( 1) UTILITY BOWL 16oz. LIF ( 1) SCALPEL WITH HANDLE # 11 EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.

    FDA Enforcement
    Class I ·Terminated·Customed, Inc·September 10, 2014

    ANGIOGRAPHY PACK - (1) LINE H.P. 1200 PSI 48" M/F (1) ANG. FEMORAL DRAPE WITH POUCH UF (1) PLATFORM TRAY LARGE (3) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK LIF (1) TABLE COVER REINFORCED 50" X 90" LIF (2) BAG BAND RUBBAN & TAPE UF (2) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK LIF (5) ABSORBENT TOWELS 15" X 20" LIF (1) SYRINGE 30cc WITHOUT NEEDLE LUER LOCK LIF (1) SURGICAL DURAPREP SOLUTION 6ML LIF (1) SAFETY SCALPEL #11 STAINLESS STEEL (2) GOWN STANDARD SMS LARGE VELCRO NECK (1) MANIFOLD WITH CONTROL SYRINGE (1) NEEDLE 18G X 2% AMC/4 (2) UTILITY BOWL 16oz UF (2) CLOTH HUCK TOWEL BLUE (2) NEEDLE HYPODERMIC 21 G X 1 ~ LIF (2) MEDICINE CUP 2oz LIF (30) GAUZE SPONGE 4" X 4" 16PL Y (1) NEEDLE HYPODEMIC 18G X 1 ~ (4) TOWEL CLAMP (2) SYRINGE 3cc WITHOUT NEEEDLE LUER LOCK LIF (1) HALSTED MOSQUITO CVD 5" SERRAT (2) SYRINGE 5cc WITHOUT NEEDLE LUER LOCK L/F (2) NEEDLE HYPODERMIC 22G X 1 EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.

    FDA Enforcement
    Class I ·Terminated·Customed, Inc·September 10, 2014

    FEMORAL ANGIOGRAPHY PACK - (1) TABLE COVER REINFORCED 50" X 90" UF (1) GOWN LARGE SMS IMPERVIOUS REINFORCED LIF (1) TOWEL ABSORBENT 15" X 20" UF (1) DRAPE ANGlO 75" X 145" (4) TOWELS CLOTH HUCK (BLUE) UF (3) SYRINGE 1 Occ WITHOUT NEEDLE LUER LOCK UF (1) IV ADM SET 15ML 1 06" LONG LIF (20) GAUZE SPONGE 4" X 4" 12PL Y LIF (1) NEEDLE HYPODERMIC 18G X 1Y:. ST. UF (1) NEEDLE HYPODERMIC 21G X 1Y:. ST. LIF (2) MEDICINE CUP 2oz. CLEAR LIF (1) SCALPEL WEIGHTED SAFETY #11 (2) CHLORASCRUB SWABSTICK 5.1 ML LIF (1) GOWN SURG REINFORCED LARGE TOWEL/WRAP LIF (1) SPECIMEN CONTAINER 4oz. W/LID & LABEL LIF (1) NEEDLE HYPODERMIC 25G X 5/8 ST. LIF (1) SYRINGE 3cc WITHOUT NEEDLE LUER LOCK LIF (1) FORCEP ADS ON TISS. WITH TIP LIF (1) UTILITY BOWL 32oz LIF (1) UTILITY BOWL 16oz L/F (1) FORCEP KELLY STRAIGHT 5.5" LIF (1) MOSQUITO HALSTED CVD 5" LIF (1) TRAY ORGANIZER FULL DEEP LIF (1) SCISSOR MAYO 6.75 STRAIGHT LIF (1) HOLDER NEEDLE WEBSTER 4.75 LIF (1) GUIDEWIRE .035" X 150cm UF (1) TIME OUT BEACON NON WOVEN ST. UF (1) MAYO TRAY SMALL LIF (2) TOWEL CLAMP UF (2) BAG BAND RUBBAND & TAPE LIF (1) Pr. GLOVE SURG. #7Y:. DERMA PRENE P/F LIF (2) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK LIF LABEL SAMPLE (1) NEEDLE & BLADE COUNTER 60C FOAM STRIP/MAG STRIP LIF (1) NEEDLE 18G X 2 o/.i AMC/4 (1) SKIN MARKER INK WITH/8 LABEL EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.

    FDA Enforcement
    Class I ·Terminated·Customed, Inc·September 10, 2014

    Description/REF: RA CATH KIT: 20 GA X 1-1/2IN/NA-04220-1A; RA CATH KIT: 20 GA X 1-1/2IN/NA-04220-X1A; ARTERIAL CATHETER KIT: 18 GA X 16 CM/ASK-04018-HCA; ARTERIAL CATHETER KIT: 18 GA X 16 CM/ASK-04018-UPM; RA CATH KIT: 20 GA X 1-3/4IN/ASK-04020-HC; ARTERIAL LINE KIT: 20 GA X 5IN (12 CM)/ASK-04020-HMC; RADIAL ARTERY CATHETER KIT: 20 GA X 30MM/ASK-04020-MMC; RA CATH KIT: 20 GA X 1-1/2IN (3.81 CM)/ASK-04020-SV; ARTERIAL CATH KIT: 20 GA X 5 IN (12 CM)/ASK-04100-AMC-S1; ARTERIAL CATHETER KIT: 20 GA X 12 CM/ASK-04100-NS; RADIAL ARTERY KIT/ASK-04500-AH; RAD ART:20GAX3.81CM / ART LINE:20GAX12CM/ASK-04500-HF-S; ARTERIAL LINE KIT: 1L 20 GA X 12 CM/ASK-04510-HA; ARTERIAL LINE KIT: 20 GA. X 5 IN (12 CM)/ASK-04510-HF; ARTERIAL LINE KIT: 20 GA X 5 IN (12 CM)/ASK-04510-IHC1; ARTERIAL LINE KIT: 20 GA X 5 IN (12 CM)/ASK-04510-MSK2; ARTERIAL CATH KIT: 20GA X 5IN/ASK-04510-NS; ARTERIAL CATHETER KIT: 20 GA X 12 CM/FS-04510-S; ARTERIAL LINE KIT/HF-04510-1; RA CATH KIT: 20 GA X 1-3/4IN/ASK-04020-BSM; RA CATH KIT: 20 GA X 1 3/4 IN (4.45CM)/ASK-04020-HH1; RA CATH KIT: 20 GA X 1 3/4 IN (4.45 CM)/ASK-04020-JMH1; RA CATH KIT: 20 GA X 1-3/4 IN/ASK-04020-MAS; RA CATH KIT: 20 GA X 1 3/4 IN/ASK-04020-MCC; RA CATH KIT: 20 GA X 1-3/4IN (4.45 CM)/ASK-04020-MHT; RA CATH KIT: 20 GA X 1-3/4IN (4.45 CM)/ASK-04020-MI; RA CATH KIT: 20 GA X 1 3/4 IN (4.45 CM)/ASK-04020-MIHS; RA CATH KIT: 20 GA X 1-3/4IN (4.45 CM)/ASK-04020-MUSC; RA CATH KIT: 20 GA X 1-3/4IN (4.45 CM)/ASK-04020-NCB; RA CATH KIT: 20 GA X 1 3/4 IN/ASK-04020-PMC; RA CATH KIT: 20 GA X 1-3/4IN (4.45 CM)/ASK-04020-SPH; RA CATH SET: 20 GA X 1-3/4IN (4.45CM)/ASK-04020-UPM; RA CATH KIT: 20 GA X 1 3/4 IN (4.45 CM)/ASK-04020-UR1; RA CATH KIT: 20 GA X 4.45 CM/NA-04020-X1A; RA CATH KIT: 20 GA X 1-3/4IN/WBH-04020-1; CVC KIT: 20 GA X 12CM/ASK-04510-UCLA; ARTERIAL ACCESS TRAY WITH .025IN SWG/ASK-04001-BW1

    FDA Enforcement
    Class I ·Ongoing·ARROW INTERNATIONAL, LLC·June 24, 2026

    Description/REF: EPIDURAL CATHETER KIT: 19 GA X 90 CM/ASK-05502-VM1; EPIDURAL CATHETERIZATION KIT: 19 GA/AK-05501; EPIDURAL CATHETERIZATION KIT/AK-05502; EPIDURAL CATHETERIZATION KIT/AK-05502D; EPIDURAL CATHETERIZATION KIT/AK-05503; EPIDURAL CATHETERIZATION KIT/AK-05503-L; SPINAL ANES/EPIDURAL CATH KIT/AK-05560; SPINAL ANES/EPIDURAL CATH KIT/ASK-02520-SBMC1; EPIDURAL CATHETERIZATION KIT/ASK-05400-BW1; EPIDURAL CATHETERIZATION KIT/ASK-05400-GH; SPINAL ANES/EPIDURAL CATH KIT/ASK-05401-LMC; EPIDURAL CATHETERIZATION KIT/ASK-05401-NM; SPINAL ANES/EPIDURAL CATH KIT/ASK-05500-BID1; EPIDURAL CATHETERIZATION KIT: 19 GA/ASK-05500-JHH1; EPIDURAL CATHETERIZATION KIT: 19 GA/ASK-05500-MCV1; EPIDURAL CATHETER KIT: 19GA X 90CM ASK-05500-MVH; EPIDURAL CATHETER KIT: 19 GA X 90 CM/ASK-05500-UMC; 19 GA X 35.5 IN EPIDURAL CATHETER KIT/ASK-05502-MLH; SPINAL ANES/EPIDURAL CATH KIT/ASK-05560-JMH1; SPINAL ANES/EPIDURAL CATH KIT/ASK-05560-MKD2; SPINAL ANES/EPIDURAL CATH KIT/ASK-05560-OM1; EPIDURAL CATHETERIZATION KIT/ASK-17019-SM; EPIDURAL CATHETERIZATION KIT/BP-05501; EPIDURAL CATHETERIZATION KIT/CK-05401; EPIDURAL CATHETERIZATION KIT/HS-05501; EPIDURAL CATHETERIZATION KIT/MM-05501; EPIDURAL CATHETERIZATION KIT: 19 GA/MP-17019-TK; EPIDURAL CATHETERIZATION KIT: 19 GA/MP-17019-TKD; EPIDURAL CATHETERIZATION KIT: 19 GA/MP-17019-TKL; EPIDURAL CATHETERIZATION KIT/MSO-05401-JMH; EPIDURAL CATHETERIZATION KIT/NM-05401; EPIDURAL CATHETERIZATION KIT/SJ-05501; EPIDURAL CATHETERIZATION KIT/SM-05401; EPIDURAL CATHETER KIT: 19 GA X 90 CM/TM-05401; EPIDURAL CATHETERIZATION KIT/TM-05502; SPINAL ANES/EPIDURAL CATH KIT/UI-05502; SPINAL ANES/EPIDURAL CATH KIT: 19 GA/ASK-05400-SHM; EPIDURAL CATH KIT: 19 GA/ASK-05400-UOM; EPIDURAL CATHETER KIT: 19 GA X 90 CM/ASK-05500-MR; EPIDURAL CATHETERIZATION KIT: 19 GA/ASK-05500-TM; EPIDURAL CATHETERIZATION KIT/ASK-05501-BHL1; EPIDURAL CATHETERIZATION KIT/ASK-05501-GH; EPIDURAL CATHETER KIT: 19 GA X 90 CM/ASK-05501-SM; EPIDURAL CATHETERIZATION KIT/ASK-05502-BSM; EPIDURAL CATHETERIZATION KIT/ASK-05502-MGH1; EPIDURAL CATHETERIZATION KIT/ASK-05503-BWB1; EPIDURAL CATHETERIZATION KIT/ASK-05503-HMH; EPIDURAL CATHETER KIT: 19 GA X 90 CM/ASK-05503-SPH; EPIDURAL CATHETER KIT: 19 GA X 90 CM/ASK-05503-UPM1; SPINAL ANES/EPIDURAL CATH KIT/ASK-05560-UCI2; EPIDURAL CATHETERIZATION KIT: 19 GA/ASK-17019-UMP; EPIDURAL CATHETERIZATION KIT/MH-05503-1; EPIDURAL CATHETERIZATION KIT/ASK-05401-VB2; Epidural Catheterization Kit: 19GA/ASK-05500-SC1; Epidural Catheterization Kit: 19GA/ASK-05500-SC3; EPIDURAL CATHETER KIT: 19 GA X 90 CM/ASK-05501-AFH1; EPIDURAL CATHETER KIT: 19 GA X 90 CM/ASK-05501-BMC; EPIDURAL CATHETERIZATION KIT/ASK-05502-NY; EPIDURAL CATHETERIZATION KIT/ASK-17019-RMH

    FDA Enforcement
    Class I ·Ongoing·ARROW INTERNATIONAL, LLC·June 24, 2026

    Impella CP Set with SmartAssist. Product Codes: 1000080, 1000851, 0048-0014, 0048-0024-JP.

    FDA Enforcement
    Class I ·Ongoing·Abiomed, Inc.·June 24, 2026

    Atlan A350XL. Model Number: 8621600. anesthesia workstation

    FDA Enforcement
    Class I ·Ongoing·Draeger, Inc.·June 10, 2026

    Automated Impella Controller (AIC) with the below product descriptions and corresponding Product Codes. 1. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA. 2. Impella Controller, Packaged, EU; Product Code: 0042-0000-EU. 3. Impella Controller, Packaged, UK; Product Code: 0042-0000-UK. 4. Impella Controller, Packaged, US; Product Code: 0042-0000-US.

    FDA Enforcement
    Class I ·Ongoing·Abiomed, Inc.·June 3, 2026

    Rolls of label stock used with the Omnicell i.v.Station. 1. Part Number 258920028, LABEL, STERILE, IVSTATION SYRINGE (40MMX40MM). 2. Part Number 258900029, LABEL, STERILE, IVSTATION SYRINGE (20MMX40MM). Model/Catalog Number: IVS-RBT-001. i.v.STATION is an automation device used for preparation and compounding of IV medications, which also applies labels to compounded preparations for identification and traceability.

    FDA Enforcement
    Class I ·Ongoing·Omnicell, Inc.·May 20, 2026

    Atlan A350. Model Number: 8211500. anesthesia workstation

    FDA Enforcement
    Class I ·Ongoing·Draeger, Inc.·June 10, 2026

    Automated Impella Controller (AIC); Product Code: 0042-0000-US;

    FDA Enforcement
    Class I ·Ongoing·Abiomed, Inc.·June 3, 2026

    WHILL Model C2, with software versions before HMI: 2.22 / MC: 1.13; device is an indoor/outdoor battery-operated 2-wheel drive (rear-wheel drive) powered wheelchair.

    FDA Enforcement
    Class I ·Ongoing·WHILL, INC.·May 6, 2026

    WHILL Model F, with software versions before HMI: 2.23 / MC: 1.05; the device is an indoor/outdoor, foldable battery-operated 2-wheel drive (rear-wheel drive) powered wheelchair.

    FDA Enforcement
    Class I ·Ongoing·WHILL, INC.·May 6, 2026

    Impella RP Flex with SmartAssist. Product Code: 1000323.

    FDA Enforcement
    Class I ·Ongoing·Abiomed, Inc.·March 11, 2026

    Automated Impella Controller (AIC), labeled as the following with corresponding Product Codes: 1. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA. 2. Impella Controller, Packaged, EU; Product Code: 0042-0000-EU. 3. Impella Controller, Packaged, UK; Product Code: 0042-0000-UK. 4. Impella Controller, Packaged, US; Product Code: 0042-0000-US. 5. Impella Optical Controller, Packaged, EU; Product Code: 0042-0010-EU. 6. Impella Optical Controller, Packaged, UK; Product Code: 0042-0010-UK. 7. Optical AIC w/Impella Connect, Pack'd, CA; Product Code: 0042-0040-CA. 8. Optical AIC w/Impella Connect, Pack'd, EU; Product Code: 0042-0040-EU. 9. Optical, AIC, Impella Connect, Pkgd, AU; Product Code: 0042-0040-AU.

    FDA Enforcement
    Class I ·Ongoing·Abiomed, Inc.·April 8, 2026