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Serious riskFDA DeviceClass I

Abiomed Impella purge cassettes recalled for purge leak risk

Abiomed is recalling purge cassettes used in Impella heart pump systems because Generation 1 cassettes have an increased risk of leaking during use. This affects multiple Impella pump models sold globally, with specific batch numbers identified from 2024.

From the FDA notice · Read the official notice ↗ · All Abiomed recalls

What to do

  1. If you use an Abiomed Impella pump system, contact your healthcare provider or hospital immediately with your product code and batch number
  2. Do not discard your equipment—your medical team will advise on next steps
  3. Check the FDA website or contact Abiomed for the complete list of affected batch numbers matching your device
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

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).
Sold in
Nationwide
Made for
Adults (0 months and older)

Details

Units affected
33,107 units
Illnesses reported
None reported
Manufactured in
22 Cherry Hill Dr, Danvers, MA, United States
Classification
Class I
Recall number
Z-1589-2026

In the FDA's words

Description
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). Increased risk of purge leaks with Generation 1 purge cassettes. 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, 2024317650, 2024317651, 2024317652, 2024317653, 2024317654, 2024317655, 2024317657, 2024317660, 2024324585, 2024324587, 2024324588, 2024324589, 2024324591, 2024324592, 2024324593, 2024324594, 2024324595, 2024324596, 2024328613, 2024328619, 2024328620, 2024328622, 2024328625, 2024328629, 2024328634, 2024328636, 2024328640, 2024328641, 2024328666, 2024328670, 2024328675, 2024328692, 2024328706, 2024328716, 2024328718, 2024328720, 2024328722, 2024328723, 2024328737, 2024328741, 2024328743, 2024328749, 2024328752, 2024328755, 2024328760, 2024328762, 2024328764, 2024328767, 2024328778, 2024328780, 2024328782, 2024328785, 2024328788, 2024328790, 2024328792, 2024328795, 2024328798, 2024328801, 2024328878, 2024328879, 2024328880, 2024328881, 2024328892, 2024328893, 2024328894, 2024328896, 2024328897, 2024328898, 2024328912, 2024328913, 2024328914, 2024328915, 2024328917, 2024328919, 2024328920, 2024328922, 2024328923, 2024328924, 2024329278, 2024329279, 2024329281, 2024329477, 2024329492, 2024329497, 2024329504, 2024329506, 2024329508, 2024329511, 2024329513, 2024329517, 2024329521, 2024329540, 2024329577, 2024329581, 2024329595, 2024329600, 2024329610, 2024329616, 2024329623, 2024329640, 2024329645, 2024329688, 2024329689, 2024329690, 2024329695, 2024329697, 2024329698, 2024329701, 2024329702, 2024329704, 2024329709, 2024329816, 2024329820, 2024329821, 2024329827, 2024329829, 2024329838, 2024329840, 2024329843, 2024329846, 2024329849, 2024330386, 2024330389, 2024330391, 2024330395, 2024330396, 2024330420, 2024330422, 2024330423, 2024330425, 2024330427, 2024330753, 2024330754, 2024330755, 2024330756, 2024330757, 2024330758, 2024330759, 2024330760, 2024331236, 2024331237, 2024331240, 2024331241, 2024331242, 2024331243, 2024331245, 2024331247, 2024331248, 2024331249, 2024331262, 2024331263, 2024331264, 2024331265, 2024331266, 2024331268, 2024331270, 2024331271, 2024331276, 2024331277, 2024331282, 2024331293, 2024331294, 2024331296, 2024331297, 2024331299, 2024331303, 2024331305, 2024331309, 2024331312, 2024331314, 2024331318, 2024331319, 2024331322, 202
Hazard
Increased risk of purge leaks with Generation 1 purge cassettes.

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