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    Brand Name: N/A Product Name: Repeater Bone Tamp Model/Catalog Number: ASY-00132 Software Version: N/A Product Description: The Repeater Bone Tamp is a cylindrical shaft used to push bone graft material through a corresponding bone funnel into the FlareHawk interbody fusion device in spinal fusion procedures. Component: No

    FDA Recall
    Open, Classified ·Integrity Implants Inc.·Product code LXH·December 20, 2024

    Medline Fluid Delivery Set with Drip Chamber: 1) FDS,135,CHMN,W/F,MLL,RC(2),PG, Item Number 99000069; 2) FDS,135,NV,MICRO-CHAMBER,W/FILTER,BLUE, Item Number 949000222; 3) FDS,135,NV,MICRO-CHAMBER,W/FILTER,GREEN, Item Number 949000224; 4) FDS,135,NV,MICRO-CHAMBER,W/FILTER,RED, Item Number 949000221; 5) FDS,135,NV,MICRO-CHAMBER,W/FILTER,YELLOW, Item Number 949000223

    FDA Recall
    Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code FPA·December 16, 2024

    2090 Programmers with serial number prefixes PKK0 and PKK1: a) 2090, Product Description: PRGM 2090 PROGRAMMER-PORTABLE CRM; b) 209031, Product Description: PROGRAMMER 209031 PORTABLE CRM; c) 2090AA, Product Description: PROGRAMMER 2090AA PORTABLE CRM; d) 2090AA4, Product Description: 2090AA4 PROGRAMMER-PORTABLE CRM; e) 2090AC, Product Description: SFTWR 2090AC PROGRAMMER-PORTABLE CRM W/; f) 2090AM, Product Description: PROGRAMMER CARELINK HONG KONG ASIA; g) 2090CHEN, Product Description: PRGM 2090CHEN PKG-ASSY PROGRAMMER 2090; h) 2090CHFR, Product Description: PRGM 2090CHFR PKG-ASSY PROGRAMMER 2090; i) 2090CL, Product Description: PROGRAMMER 2090CL INTL-JAPAN MKT; j) 2090EN, Product Description: PRGM 2090EN PKG-ASSY PROGRAMMER 2090 UK; k) 2090FR, Product Description: PRGM 2090FR PKG-ASSY PROGRAMMER 2090 IN; l) 2090LDEN, Product Description: PRGM 2090LDEN PROGRAMMER-PORTABLE LOANE; m) 2090NL, Product Description: PRGM 2090NL PKG-ASSY PROGRAMMER 2090 IN; n) 2090W, Product Description: PROGRAMMER 2090W TELEMETRY C; o) 2090WCHDE, Product Description: PROGRAMMER 2090WCHDE SWISS-GERMAN; p) 2090WCHEN, Product Description: PROGRAMMER 2090WCHEN SWISS-ENGLISH; q) 2090WCHFR, Product Description: PROGRAMMER 2090WCHFR SWISS-FRENCH; r) 2090WDE, Product Description: PROGRAMMER 2090WDE GERMAN MKT; s) 2090WFR, Product Description: PROGRAMMER 2090WFR FRENCH MKT; t) 2090WLD, Product Description: PROG 2090WLD ALL LANGUAGES W/ANALYZER; u) 2090WNL, Product Description: PROGRAMMER 2090WNL NETHERLANDS MKT

    FDA Recall
    Open, Classified ·Medtronic Inc.·Product code NVZ·July 11, 2024

    Medtronic I.M.A. Cannulae: DLP 1 mm Arteriotomy Cannula, Model Number 31001

    FDA Recall
    Open, Classified ·Medtronic Perfusion Systems·Product code DWF·March 19, 2024

    EOPA Arterial Cannula, Model Numbers 77422 (22 Fr) and 77418 (18 Fr)

    FDA Recall
    Open, Classified ·Medtronic Perfusion Systems·Product code DWF·December 12, 2024

    DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12115 LV VENT 15FR, Model Number 12115

    FDA Recall
    Open, Classified ·Medtronic Perfusion Systems·Product code DWF·August 6, 2025

    Aortic Root Cannula: 1. DLP Aortic Root Cannula A. CANNULA 11012 AR FLOWGUARD 12GA, model no 11012 B. CANNULA 11014 AR FLOWGUARD 14GA, model no. 11014 2. MiAR Cannula: A. CANNULA 11012L AR FLOWGUARD LONG 12GA, model no 11012L B. CANNULA 11014L AR FLOWGUARD 14FR LONG, model no. 11014L 3. DLP Aortic Root Cannula with Vent Line A. CANNULA 21012 AR VENT FLOW 12GA, model no. 21012 B. CANNULA 21014 AR VENT FLOW 14GA, model no. 21014

    FDA Recall
    Open, Classified ·Medtronic Perfusion Systems·Product code DWF·February 5, 2025

    Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94665; Cardiopulmonary bypass vascular catheter

    FDA Recall
    Open, Classified ·Medtronic Perfusion Systems·Product code DWF·April 21, 2026

    Medtronic Left Heart Vent Catheters: a) DLP Intracardiac Sump 20 Fr, Model Number 12012, b) DLP Left Heart Vent Catheter 10 Fr., Model Number 12008, c) DLP Left Heart Vent Catheter 13 Fr., Model Number 12001, d) DLP Left Heart Vent Catheter 13 Fr., Model Number 12113, e) DLP Left Heart Vent Catheter 16 Fr., Model Number 12016, f) DLP Left Heart Vent Catheter 20 Fr. Model Number 12002, g) DLP Left Heart Vent Catheter 20 Fr. Model Number 12220, h) DLP Pericardial Sump 38.1 cm (15 in), Model Number 12010,

    FDA Recall
    Open, Classified ·Medtronic Perfusion Systems·Product code DWF·March 19, 2024

    Medtronic Arterial Cannulae packaged as: a) DLP Curved Metal Tip Arterial Cannula 20 Fr., Model Number 80020; b) DLP Curved Metal Tip Arterial Cannula 20 Fr., Model Number 80220; c) DLP Curved Metal Tip Arterial Cannula 20 Fr., Model Number 82020; d) DLP Curved Metal Tip Arterial Cannula 20 Fr., Model Number 87120; e) DLP Curved Metal Tip Arterial Cannula 22 Fr. , Model Number 80222; f) DLP Curved Metal Tip Arterial Cannula 22 Fr. , Model Number 87122; g) DLP Curved Tip Arterial Cannula 20 Fr., Model Number 87220; h) DLP Curved Tip Arterial Cannula 22 Fr., Model Number 87222; i) DLP" One-Piece Arterial Cannulae, Pediatric 6 Fr, Model Number 77006; j) DLP" One-Piece Pediatric Arterial Cannula 6 Fr, Model Number 77206; k) DLP" One-Piece Pediatric Arterial Cannula 8 Fr, Model Number 77008; l) DLP" One-Piece Pediatric Arterial Cannula 10 Fr, Model Number 77010; m) DLP" One-Piece Pediatric Arterial Cannula 10 Fr, Model Number 77110; n) DLP" One-Piece Pediatric Arterial Cannula 12 Fr, Model Number 77112; o) EOPA" Elongated One Piece Arterial Cannula 20 Fr., Model Number 77420; p) EOPA" Elongated One Piece Arterial Cannula 22 Fr., Model Number 77422; q) EOPA" Elongated One Piece Arterial Cannula 22 Fr., Model Number 77522; r) EOPA" Elongated One Piece Arterial Cannula 22 Fr., Model Number 77622; s) EOPA" Elongated One Piece Arterial Cannula 24 Fr., Model Number 77524; t) Select Series" Angled Tip Arterial Cannula 24Fr., Model Number 72424; u) Select Series" Straight Tip Arterial Cannula 20 Fr., Model Number 72120; v) Select Series" Straight Tip Arterial Cannula 24 Fr., Model Number 72224

    FDA Recall
    Open, Classified ·Medtronic Perfusion Systems·Product code DWF·March 19, 2024

    Medtronic Cardioplegia Adapters: a) DLP 1.8 m (6 ft) Pressure Monitoring Extension Line Adapter, Model Number 25009, b) DLP 1.8 m (6 ft) Pressure Monitoring Extension Line Adapter, Model Number 25010, c) DLP 30.5 cm (12 in) Multiple Perfusion Set, Model Number 14003, d) DLP 38.1 cm (15 in) Multiple Perfusion Set, Model Number 14000, e) DLP 50.8 cm (20 in) Extension Line Adapter, Model Number 11001G, f) DLP Perfusion/Venting Adapter, Model Number 13002, g) DLP Y Adapter Coronary Perfusion, Model Number 10710

    FDA Recall
    Open, Classified ·Medtronic Perfusion Systems·Product code DWF·March 19, 2024

    DLP Pediatric One-Piece Arterial Cannulae, Model Numbers 77008 (8 Fr) and 77014 (14 Fr)

    FDA Recall
    Open, Classified ·Medtronic Perfusion Systems·Product code DWF·December 12, 2024

    Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94915; Cardiopulmonary bypass vascular catheter

    FDA Recall
    Open, Classified ·Medtronic Perfusion Systems·Product code DWF·April 21, 2026

    Medtronic Venous Cannulae: a) DLP 20 Fr. Malleable Single Stage Venous Cannula, Model Number 68120, b) DLP 24 Fr. Malleable Single Stage Venous Cannula, Model Number 68124, c) DLP 28 Fr. Malleable Single Stage Venous Cannula, Model Number 68128, d) DLP 30 Fr. Malleable Single Stage Venous Cannula, Model Number 68130, e) DLP 34 Fr. Malleable Single Stage Venous Cannula, Model Number 68134, f) DLP 12 Fr. Single Stage Venous Cannula, Model Number 67312, g) DLP 16 Fr. Single Stage Venous Cannula, Model Number 67316, h) DLP 16 Fr. Single Stage Venous Cannula, Model Number 67516, i) DLP 18 Fr. Single Stage Venous Cannula, Model Number 66118, j) DLP 18 Fr. Single Stage Venous Cannula, Model Number 67318, k) DLP 20 Fr. Single Stage Venous Cannula, Model Number 67320, l) DLP 20 Fr. Single Stage Venous Cannula, Model Number 69320, m) DLP 20 Fr. Single Stage Venous Cannula, Model Number 67520, n) DLP 22 Fr. Single Stage Venous Cannula, Model Number 66122, o) DLP 22 Fr. Single Stage Venous Cannula, Model Number 67522, p) DLP 24 Fr. Single Stage Venous Cannula, Model Number 67524, q) DLP 26 Fr. Single Stage Venous Cannula, Model Number 67526, r) DLP 28 Fr. Single Stage Venous Cannula, Model Number 66128, s) DLP 28 Fr. Single Stage Venous Cannula, Model Number 39628, t) DLP 28 Fr. Single Stage Venous Cannula, Model Number 67528, u) DLP 30 Fr. Single Stage Venous Cannula, Model Number 66130, v) DLP 31 Fr. Single Stage Venous Cannula, Model Number 69331, w) DLP 32 Fr. Single Stage Venous Cannula, Model Number 66132, x) DLP 34 Fr. Single Stage Venous Cannula, Model Number 67534, y) DLP 36 Fr. Single Stage Venous Cannula, Model Number 66236, z) MC2 28/36 Fr. Two Stage Venous Cannula, Model Number 91228, aa) MC2 29/37 Fr. Two Stage Venous Cannula, Model Number 91229C, bb) MC2 32/40 Fr. Two Stage Venous Cannula, Model Number 91263, cc) MC2 32/40 Fr. Two Stage Venous Cannula, Model Number 91240C, dd) MC2 32/40 Fr. Two Stage Venous Cannula, Model Number 91263C, ee) MC2 34/46 Fr. Two Stage Venous Cannula, Model Number 91246, ff) MC2 34/46 Fr. Two Stage Venous Cannula, Model Number 91246C, gg) MC2 36/46 Fr. Two Stage Venous Cannula, Model Number 91236C, hh) MC2 36/51 Fr. Two Stage Venous Cannula, Model Number 91251, ii) MC2 36/51 Fr. Two Stage Venous Cannula, Model Number 91251C, jj) VC2" 34/38 Fr. Venous Cannula, Model Number 93438, kk) VC2" 34/48 Fr. Venous Cannula, Model Number 93448C

    FDA Recall
    Open, Classified ·Medtronic Perfusion Systems·Product code DWF·March 19, 2024

    DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12113 LV VENT 13FR, Model Number 12113

    FDA Recall
    Open, Classified ·Medtronic Perfusion Systems·Product code DWF·August 6, 2025

    SHIP KIT, PROCEDURE KIT, PROTEKDUO LS - DL31 for temporary Cardiopulmonary bypass. Including the following components: a) 31 Fr ProtekDuo Veno-Venous Cannula Set b) LifeSPARC Pump c) 14Fr to 26 Fr Dilator Set d) TandemHeart Wrap. Kit Number: 5820-3118 Intended use is applicable to the intended use of specific devices included in the kit.

    FDA Recall
    Open, Classified ·Cardiac Assist, Inc·Product code DWF·October 14, 2021

    Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94965; Cardiopulmonary bypass vascular catheter

    FDA Recall
    Open, Classified ·Medtronic Perfusion Systems·Product code DWF·April 21, 2026

    Medtronic DLP Aortic Root Cannula with Flow-Guard, REF 11012; for use in cardiopulmonary bypass surgery

    FDA Recall
    Open, Classified ·Medtronic Perfusion Systems·Product code DWF·October 3, 2024

    DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12110 LV VENT 10FR, Model Number 12110

    FDA Recall
    Open, Classified ·Medtronic Perfusion Systems·Product code DWF·August 6, 2025

    Medtronic Custom Perfusion kits, with the following product descriptions and corresponding model numbers: 1. CUSTOM PACK BB10Q85R FILTER (Model BB10Q85R); 2. CUSTOM PACK BB11C01R MIDI DEEP (Model BB11C01R); 3. CUSTOM PACK BB7H95R22 HYP MAIN (Model B7H95R22); 4. CUSTOM PACK BB7H95R25 HYP MAIN (Model BB7H95R25); 5. CUSTOM PACK BB7H99R22 NEONAT (Model BB7H99R22); 6. CUSTOM PACK BB7P46R4 316-14 (Model BB7P46R4); 7. CUSTOM PACK BB7P48R4 14-38 (Model BB7P48R4); 8. CUSTOM PACK BB7W03R8 CCSM NEON (Model BB7W03R8); 9. CUSTOM PACK BB7W80R7 BASC PEDS (Model BB7W80R7); 10. CUSTOM PACK BB8B09R7 INFANT (Model BB8B09R7); 11. CUSTOM PACK BB8B09R8 INFANT (Model BB8B09R8); 12. CUSTOM PACK BB8D40R3 P3/16X1/4 (Model BB8D40R3); 13. CUSTOM PACK BB8Q16R PED ART (Model BB8Q16R); 14. CUSTOM PACK BB8V01R8 FVDL COLM (Model BB8V01R8); 15. CUSTOM PACK HY2V10R33 ADULT (Model HY2V10R33); 16. CUSTOM PACK HY3Z71R17 PRIMARY (Model HY3Z71R17); 17. CUSTOM PACK HY3Z71R18 PRIMARY (Model HY3Z71R18); 18. CUSTOM PACK HY4V00R24 ADULT (Model HY4V00R24); 19. CUSTOM PACK HY6X29R12 CON-SUPP (Model HY6X29R12); 20. CUSTOM PACK HY8L14R7 HYBRID (Model HY8L14R7); 21. CUSTOM PACK HY8P36R6 CPS (Model HY8P36R6); 22. CUSTOM PACK HY8V01R6 FVDL COLM (Model HY8V01R6); 23. CUSTOM PACK HY9D36R1 HL PUMP P (Model HY9D36R1); 24. CUSTOM PACK HY9L07R4 ADLT FUS (Model HY9L07R4); 25. CUSTOM PACK HY9L80R4 SADT FUS (Model HY9L80R4); 26. CUSTOM PACK HY9M47R6 ADLT MAIN (Model HY9M47R6); 27. CUSTOM PACK HY9N38R4 VGH FUS (Model HY9N38R4); 28. CUSTOM PACK HY9R26R12 CENT (Model HY9R26R12); 29. PERFUSION M337112Q 1/B (Model M337112Q); 30. PERFUSION M344130B 1/B (Model M344130B); 31. PERFUSION M392419C 1/B (Model M392419C); 32. PERFUSION M394213B 1/B (Model M394213B); 33. PERFUSION M394213C 1/B (Model M394213C); 34. PERFUSION M490124D 1/B (Model M490124D); 35. PERFUSION M491335A 1/B (Model M491335A); 36. PERFUSION M499709E 1/B (Model M499709E); 37. PERFUSION M960164F 1/B (Model M960164F); 38. PERFUSION M960165E 1/B (Model M960165E); 39. PERFUSION M960169E 1/B (Model M960169E); 40. PERFUSION M960462C 1/B (Model M960462C); 41. PERFUSION M960462D 1/B (Model M960462D); 42. PERFUSION M960463D 1/B (Model M960463D); 43. PERFUSION M960466D 1/B (Model M960466D); 44. CUSTOM PACK TL4K33R3 FCI ADULT (Model TL4K33R3); 45. CUSTOM PACK TL4K95R12 PERFNPLEG (Model TL4K95R12); 46. CUSTOM PACK TL6C91R5 SELLKE PK (Model TL6C91R5); 47. CUSTOM PACK TL6G48R9 ST PAULS (Model TL6G48R9); 48. CUSTOM PACK TL7X09R3 FCVC ADLT (Model TL7X09R3);

    FDA Recall
    Open, Classified ·Medtronic Perfusion Systems·Product code DWF·October 12, 2021