Abiomed Impella CP Smart Assist Set Heart Pump Introducer Sheath Leakage
Abiomed is recalling the Impella CP Smart Assist Set due to a potential for introducer sheath leakage from under the sheath cap and along hub score lines in 14Fr and 23Fr introducers. These manufacturing issues are not visually detectable.
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 requires a minimum severity score of 4 per the rubric. This is a heart pump device where introducer sheath leakage poses a risk of serious harm during use, making it a medical device defect affecting patient safety.
Plain-English summary
Abiomed, Inc. is recalling the ABIOMED Impella CP Smart Assist Set, JP (Pump Set Code 0048-0024-JP; Introducer Product Code 0052-3025-JP), a heart pump and accessories device. The recall affects approximately 8,382 units distributed worldwide.
The recall is due to a potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr introducers. These manufacturing issues are not visually detectable by the user. Since 14Fr or 23Fr introducers are provided in every pump set, all current batches in the field are affected.
The device has been distributed worldwide across the US, 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, the Netherlands, Norway, Panama, Poland, Saudi Arabia, Serbia, Slovenia, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, the United Arab Emirates, and the United Kingdom.
Healthcare facilities and users of this device should contact Abiomed, Inc. for further instructions regarding this recall.
The recalled product
- Product
- ABIOMED Impella CP Smart Assist Set, JP, Pump Set Code 0048-0024-JP; containing Introducer Product Code 0052-3025-JP. heart pump and accessories
- Manufacturer
- Abiomed, Inc.
- Affected units
- 8,382
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 (1)
- Pump Set Code 0048-0024-JP
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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