Recall archive / FDA device enforcement

Purge Cassette, sold within Impella Pump Sets and Individually Packaged. Labeled and distributed in the below configu... — FDA record Z-1589-2026

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Feb 18, 2026. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

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
Recalling firm: Abiomed, Inc.
Quantity: 33,107 units
Agency-reported status: Ongoing
Source record identifier: Z-1589-2026

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label field	Details supplied by the agency
Lot, code or applicability	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, 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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, 2024331323, 2024331324, 2024331325, 2024331326, 2024331328, 2024331329, 2024331331, 2024331352, 2024331355, 2024331360, 2024331361, 2024331363, 2024331633, 2024331638, 2024331642, 2024331644, 2024331661, 2024331664, 2024331666, 2024331670, 2024331672, 2024331676, 2024331756, 2024331757, 2024331759, 2024331762, 2024331763, 2024331764, 2024331765, 2024331766, 2024331770, 2024331771, 2024331782, 2024331783, 2024331784, 2024331785, 2024331874, 2024331875, 2024331877, 2024331878, 2024331880, 2024331881, 2024331883, 2024331884, 2024331885, 2024331886, 2024332124, 2024332126, 2024332128, 2024332134, 2024332135, 2024332136, 2024332138, 2024332139, 2024332140, 2024332141, 2024332239, 2024332244, 2024332247, 2024332251, 2024332255, 2024332266, 2024332295, 2024332321, 2024332324, 2024332326, 2024332355, 2024332358, 2024332362, 2024332366, 2024332368, 2024332369, 2024332370, 2024332371, 2024332372, 2024332373, 2024332495, 2024332497, 2024332498, 2024332499, 2024332500, 2024332501, 2024332502, 2024332505, 2024332508, 2024332509, 2024332513, 2024332514, 2024332515, 2024332516, 2024332518, 2024332520, 2024332522, 2024332524, 2024332525, 2024332527, 2024332533, 2024332534, 2024332535, 2024332537, 2024332538, 2024332541, 2024332544, 2024332545, 2024332547, 2024332549, 2024332553, 2024332555, 2024332556, 2024332557, 2024332558, 2024332559, 2024332561, 2024332562, 2024332563, 2024332564, 2024332571, 2024332573, 2024332574, 2024332576, 2024332625, 2024332626, 2024332628, 2024332630, 2024332643, 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2024335430, 2024335434, 2024335466, 2024335467, 2024335470, 2024335471, 2024335473, 2024335474, 2024335475, 2024335476, 2024335478, 2024335479, 2024335480, 2024335481, 2024335490, 2024335491, 2024335492, 2024335493, 2024335495, 2024335496, 2024335497, 2024335498, 2024335499, 2024335500, 2024335533, 2024335534, 2024335536, 2024335540, 2024335542, 2024335548, 2024335549, 2024335550, 2024335552, 2024335574, 2024335575, 2024335579, 2024335581, 2024335584, 2024335585, 2024335587, 2024335588, 2024335589, 2024335591, 2024335848, 2024335849, 2024335850, 2024335852, 2024335853, 2024335854, 2024335857, 2024335858, 2024335861, 2024335862, 2024335869, 2024335871, 2024335872, 2024335873, 2024335875, 2024335877, 2024335879, 2024335880, 2024335881, 2024335886, 2024335888, 2024335891, 2024335896, 2024335897, 2024335898, 2024335900, 2024335901, 2024335902, 2024335905, 2024335907, 2024335920, 2024336238, 2024336241, 2024336244, 2024336245, 2024336246, 2024336247, 2024336249, 2024336255, 2024336257, 2024336265, 2024336266, 2024336267, 2024336269, 2024336270, 2024336272, 2024336274, 2024336275, 2024336277, 2024336278, 2024336654, 2024336656, 2024336658, 2024336660, 2024336661, 2024336662, 2024336663, 2024336665, 2024336667, 2024336668, 2024336672, 2024336673, 2024336674, 2024336675, 2024336676, 2024336677, 2024336678, 2024336679, 2024336681, 2024336682, 2024336687, 2024336689, 2024336690, 2024336691, 2024336700, 2024336701, 2024336702, 2024336703, 2024336705, 2024336706, 2024336712, 2024336714, 2024336715, 2024336716, 2024336717, 2024336718, 2024336719, 2024336720, 2024336721, 2024336722, 2024336976, 2024336983, 2024336986, 2024336989, 2024336990, 2024336992, 2024336993, 2024336995, 2024336998, 2024336999, 2024337073, 2024337076, 2024337079, 2024337082, 2024337085, 2024337087, 2024337090, 2024337092, 2024337095, 2024337096, 2024338405, 2024338419, 2024338422, 2024338426, 2024338429, 2024338433, 2024338435, 2024338438, 2024338441, 2024338458, 2024338472, 2024338475, 2024338480, 2024338484, 2024338488, 2024338568, 2024338573, 2024338575, 2024338577, 2024338579, 2024338617, 2024338620, 2024338624, 2024338628, 2024338630, 2024338633, 2024338636, 2024338638, 2024338639, 2024338642, 2024338689, 2024338693, 2024338699, 2024338703, 2024338706, 2024338709, 2024338713, 2024338716, 2024338721, 2024338723, 2024339670, 2024339672, 2024339726, 2024339728, 2024339729, 2024339731, 2024339733, 2024339734, 2024339735, 2024339737, 2024339739, 2024339740, 2024339744, 2024339746, 2024339751, 2024339752, 2024339754, 2024339756, 2024339757, 2024339760, 2024339764, 2024339767, 2024339776, 2024339777, 2024339778, 2024339780, 2024339784, 2024339785, 2024339787, 2024339790, 2024339792, 2024339793, 2024339801, 2024339802, 2024339803, 2024339804, 2024339805, 2024339809, 2024339812, 2024339827, 2024339830, 2024339832, 2024339843, 2024339844, 2024339846, 2024339847, 2024339848, 2024339849, 2024339851, 2024339854, 2024339855, 2024339858, 2024339899, 2024339900, 2024339901, 2024339910, 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Label field

Details supplied by the agency

Lot, code or applicability

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, 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The agency lot list is longer than this excerpt. Read the complete list at the official source.

Match all identifying details in the current notice. A brand name alone is not enough.

Distribution

Worldwide distribution.

No US distribution state could be established from this record. Check the official notice.

Dates in the source

Report date: Apr 8, 2026
Recall initiation date: Feb 18, 2026
Center classification date: Mar 31, 2026

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

What the record says

Lot and product identifiers

Distribution

Dates in the source

Related records