Abiomed Impella CP Introducer Kit heart pump accessory recall
Abiomed is recalling Impella CP Introducer Kits worldwide due to potential leakage from the introducer sheath that cannot be visually detected by users. The manufacturing defect affects 1,540 units across multiple countries.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this as a Class I recall, which per the rubric requires a severity score of at least 4. The defect involves a potential for leakage in a critical implantable cardiac device component that could result in serious patient harm.
Plain-English summary
Abiomed, Inc. is recalling the ABIOMED Impella CP Introducer Kit 14 Fr, 13 cm (Pump Set Code 0052-0038, Introducer Product Code 0052-3052) due to a potential for introducer sheath leakage from under the sheath cap and along the hub score lines. The company has identified this manufacturing issue in 14Fr and 23Fr Introducers, and these introducers are provided in every pump set. The leakage is not visually detectable by the user.
The recall affects 1,540 units distributed worldwide, including the United States, Australia, Austria, Belgium, Brazil, Brunei, Canada, China, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, Ireland, Israel, Italy, Japan, Kuwait, Luxembourg, Malaysia, Mexico, Netherlands, Norway, Panama, Poland, Saudi Arabia, Serbia, Slovenia, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, United Arab Emirates, and United Kingdom. All current batches in the field are included in this recall.
Healthcare providers who have received these introducer kits should contact Abiomed, Inc. for further guidance on identification and corrective action.
The recalled product
- Product
- ABIOMED Impella CP Introducer Kit 14 Fr, 13 cm, Pump Set Code 0052-0038, containing Kit, 14Fr Introducer, 13cm, Long Taper, Introducer Product Code 0052-3052. heart pump and accessories
- Manufacturer
- Abiomed, Inc.
- Affected units
- 1,540
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Pump Set Code 0052-0038
- Introducer Product Code 0052-3052. GTIN: 00813502011708
- 00813502012729. All current batches in field.
Distribution
Part of a larger recall action
This product is one of 13 recalled by Abiomed, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 13 products in this recall →Related recalls
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