Abiomed, Inc. recalls Purge Cassette

Recalling company

Abiomed, Inc.

Product

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).

Reason

Increased risk of purge leaks with Generation 1 purge cassettes.

Classification

Class I – a reasonable probability that use will cause serious adverse health consequences or death

Recall date

Feb 18, 2026

Reported

Apr 8, 2026

Distribution

Worldwide distribution.

Status

Ongoing

Quantity

33,107 units

Lot / codes

1. Product Code: 0043-0003. GTIN: 00813502011135. All Purge Cassette batches/lot numbers are affected. 2. Product Code: 004334. GTIN: 00813502011029. All Purge Cassette batches/lot numbers are affected. 3. Product Code: 0043-0002. GTIN: 00813502010510. All Purge Cassette batches/lot numbers are affected. Also included inside Product Code 0043-0003 above. Product Code 0043-0002 also includes innermost packaged product with Product Code 0043-0001 (GTIN: 00813502011999). 4. Product Code: 004413 (Customer facing code 005040). GTIN: 00813502010947. All Purge Cassette batches/lot numbers are affected. 5. Product Code: 0046-0011. GTIN: 04260113630273. All Purge Cassette batches/lot numbers are affected. 6. Product Code: 0048-0002. GTIN: 04260113630242. All Purge Cassette batches/lot numbers are affected. 7. Product Code: 0048-0002-BR. GTIN: 00813502011777. All Purge Cassette batches/lot numbers are affected. 8. Product Code: 0048-0014 (Also inclusive of codes 0048-0047 and 1000402 listed below). GTIN: 04260113630280. All Purge Cassette batches/lot numbers are affected. Finished Good Batch Numbers: 2024309080, 2024309083, 2024309085, 2024309088, 2024309091, 2024309095, 2024309099, 2024309104, 2024309109, 2024309112, 2024309333, 2024309335, 2024309339, 2024309343, 2024309346, 2024309347, 2024309349, 2024309350, 2024309351, 2024309355, 2024310812, 2024310813, 2024310815, 2024310817, 2024310818, 2024310819, 2024310823, 2024310824, 2024310825, 2024310826, 2024317648, 2024317649, 2

Company location

Danvers, MA

Recall type

Voluntary: Firm initiated

Recall number

Z-1589-2026

Agency

U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-1589-2026 in the FDA Enforcement Report. Also see FDA recall press releases.