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.
What this means for you
Illness, injury, or structural failure has been reported. 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.
- Hazard
- sheath-leakage
- device-failure
- manufacturing-defect
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
Distributed nationwide across the United States.
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