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Abiomed Impella Purge Cassette
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MEDICAL DEVICE RECALLCRITICAL

Abiomed Impella Purge Cassette

Abiomed is recalling Generation 1 purge cassettes due to an increased risk of purge leaks.

What to do

Check your inventory for the affected product codes and contact Abiomed for further instructions regarding the use of these devices.

Recalled
Listed
Updated
Recall No.
Z-1589-2026
Agency
FDA
Firm
Abiomed, Inc.
Recall ID
98395
Status
ONGOING

Recall at a glance

Quantity recalled
33,107 units

Why it was recalled

Abiomed is recalling Generation 1 purge cassettes due to an increased risk of purge leaks. The affected components are sold individually or as part of various Impella pump sets.

Is mine affected?

Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.

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

ProductUDI-DI
C00813502011135, 00813502011029, 00813502010510, 00813502011999, 00813502010947, 04260113630273, 04260113630242, 00813502011777, 04260113630280, 2024309080, 2024309083, 2024309085, 2024309088, 2024309091, 2024309095, 2024309099, 2024309104, 2024309109, 2024309112, 2024309333
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).–

Timeline

  1. Firm initiated recall
  2. Publicly announced
  3. Listed on Recall Canary
  4. Summary updated

Official source

View on U.S. Food and Drug Administration →

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Editorial summary by Recall Canary · summary updated 2026-06-11 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification