Abiomed, Inc. recalls Purge Cassette
Reason for recall
Increased risk of purge leaks with Generation 1 purge cassettes.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
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).
Lot / code information
- GTIN
- 00813502011135. All Purge Cassette batches/
- Lot #
- are affected. 2. Product Code: 004334
- GTIN
- 00813502011029. All Purge Cassette batches/
- Lot #
- are affected. 3. Product Code: 0043-0002
- GTIN
- 00813502010510. All Purge Cassette batches/
- Lot #
- 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 #
- are affected. 5. Product Code: 0046-0011
- GTIN
- 04260113630273. All Purge Cassette batches/
- Lot #
- are affected. 6. Product Code: 0048-0002
- GTIN
- 04260113630242. All Purge Cassette batches/
- Lot #
- are affected. 7. Product Code: 0048-0002-BR
- GTIN
- 00813502011777. All Purge Cassette batches/
- Lot #
- are affected. 8. Product Code: 0048-0014 (Also inclusive of codes 0048-0047 and 1000402 listed below)
- GTIN
- 04260113630280. All Purge Cassette batches/
- Lot #
are affected. Finished Good Batch Numbers: 2024309080, 2024309083, 2024309085, 2024309088, 2024309091, 2024309095 — +2618 moreShow all
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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20243 …
Show 7 more code fieldsShow fewer
Additional code information
4, 2024365371, 2024365373, 2024365377, 2024365378, 2024365380, 2024365381, 2024365382, 2024365383, 2024365390, 2024365391, 2024365393, 2024365429, 2024365434, 2024365438, 2024365444, 2024365463, 2024365469, 2024365473, 2024365477, 2024365478, 2024365482, 2024368164, 2024368166, 2024368168, 2024368172, 2024368176, 2024368178, 2024368182, 2024368185, 2024368187, 2024368194, 2024368235, 2024368238, 2024368243, 2024368248, 2024368253, 2024368257, 2024368261, 2024368264, 2024368270, 2024368273, 2024368285, 2024368289, 2024368290, 2024368292, 2024368293, 2024368294, 2024368295, 2024368296, 2024368298, 2024368301, 2024368306, 2024368307, 2024368308, 2024368309, 2024368310, 2024368311, 2024368312, 2024368314, 2024368316, 2024368318, 2024368456, 2024368458, 2024368459, 2024368460, 2024368461, 2024368463, 2024368464, 2024368466, 2024368467, 2024368469, 2024368479, 2024368483, 2024368484, 2024368485, 2024368486, 2024368487, 2024368489, 2024368491, 2024368492, 2024368493, 2024368500, 2024368502, 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2024383944, 2024383946, 2024383983, 202438400 …
What the firm is doing
Abiomed notified consignees on about 02/18/2026 via UPS next day airmailed letter titled "URGENT MEDICAL DEVICE RECALL (REMOVAL)." Consignees were instructed to identify and quarantine any affected Purge Cassettes in inventory, utilize the provided return shipment label to initiate return of affected cassettes, and complete and return the business reply form provided. Abiomed will provide a credit memo for returned units. Consignees were also encouraged to follow their standard process when ordering their Generation 2 Purge Cassettes, forward the notification to anyone within the facility needing to be aware as well as any customers if the product was further distributed, and to post the notification in a visible area for awareness.
DistributionShow detailsHide
Worldwide distribution.
A reasonable probability that use of the product will cause serious adverse health consequences or death.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-1589-2026
- FDA device classification · OZDOfficial FDA classification for this device type
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find Abiomed, Inc.Search for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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