ABIOMED Impella CP Heart Pump Set Introducer Sheath Leakage Risk
ABIOMED Impella CP heart pump sets contain introducers that may leak from under the sheath cap and along hub score lines. These manufacturing defects are not visible during use.
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 Class I, which per the rubric requires a minimum score of 4. A life-support cardiac device with a structural manufacturing defect affecting fluid containment poses a risk of serious injury or death if leakage occurs during patient use.
Plain-English summary
ABIOMED, Inc. is recalling the ABIOMED Impella CP Set (Pump Set Code 0048-0044 with Introducer Product Code 0052-3046) worldwide due to a potential for introducer sheath leakage. The 14Fr and 23Fr introducers included in every pump set may leak from under the sheath cap and along the hub score lines. These manufacturing issues cannot be visually detected by the user.
The recall affects 557 units distributed worldwide to the US and numerous international markets including Australia, Austria, Belgium, Brazil, Canada, China, France, Germany, Italy, Japan, Mexico, South Korea, Spain, Sweden, Switzerland, Thailand, United Kingdom, and many others. All current batches in the field are affected.
Patients and healthcare providers should contact Abiomed, Inc. for guidance on affected products and appropriate remediation steps. The leakage risk may affect device performance during clinical use.
The recalled product
- Product
- ABIOMED Impella CP Set, Pump Set Code 0048-0044; containing Introducer Product Code 0052-3046. heart pump and accessories
- Manufacturer
- Abiomed, Inc.
- Affected units
- 557
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 0048-0044
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
Same manufacturer · Abiomed, Inc.
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- SevereABIOMED Impella CP Heart Pump Introducer Sheath Leakage Risk
FDA (Devices) · 2026-07-22
Same hazard · sheath leakage
See all →- SevereAbiomed Impella CP Introducer Kit heart pump accessory recall
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- SevereAbiomed Impella CP Smart Assist Set Heart Pump Introducer Sheath Leakage
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- SevereABIOMED Impella CP Introducer Kit 14 Fr potentially defective sheath
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