430 results
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9ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class I
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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
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
Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170140
FDA Enforcement
Class I
·Ongoing·TELEFLEX LLC·July 5, 2023
Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 150040
FDA Enforcement
Class I
·Ongoing·TELEFLEX LLC·July 5, 2023
Flexi-Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 506540
FDA Enforcement
Class I
·Ongoing·TELEFLEX LLC·July 5, 2023
Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170120
FDA Enforcement
Class I
·Ongoing·TELEFLEX LLC·July 5, 2023
Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170135
FDA Enforcement
Class I
·Ongoing·TELEFLEX LLC·July 5, 2023
Flexi-Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 506525
FDA Enforcement
Class I
·Ongoing·TELEFLEX LLC·July 5, 2023
Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170060
FDA Enforcement
Class I
·Ongoing·TELEFLEX LLC·July 5, 2023
Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170150
FDA Enforcement
Class I
·Ongoing·TELEFLEX LLC·July 5, 2023
Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 150055
FDA Enforcement
Class I
·Ongoing·TELEFLEX LLC·July 5, 2023
Flexi-Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 506550
FDA Enforcement
Class I
·Ongoing·TELEFLEX LLC·July 5, 2023
Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 504555
FDA Enforcement
Class I
·Ongoing·TELEFLEX LLC·July 5, 2023
Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170085
FDA Enforcement
Class I
·Ongoing·TELEFLEX LLC·July 5, 2023
Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170090
FDA Enforcement
Class I
·Ongoing·TELEFLEX LLC·July 5, 2023
Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170130
FDA Enforcement
Class I
·Ongoing·TELEFLEX LLC·July 5, 2023
Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 504560
FDA Enforcement
Class I
·Ongoing·TELEFLEX LLC·July 5, 2023
Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170145
FDA Enforcement
Class I
·Ongoing·TELEFLEX LLC·July 5, 2023
Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 504585
FDA Enforcement
Class I
·Ongoing·TELEFLEX LLC·July 5, 2023
Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 504565
FDA Enforcement
Class I
·Ongoing·TELEFLEX LLC·July 5, 2023