ABIOMED Impella CP Heart Pump Set Introducer Sheath Leakage Risk
ABIOMED is recalling Impella CP heart pump sets worldwide due to a potential for introducer sheath leakage from under the sheath cap and along hub score lines in 14Fr and 23Fr introducers. The manufacturing defect is not visually detectable.
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 has classified this as a Class I recall, which per the rubric requires a minimum score of 4. The defect involves a life-support medical device (cardiac assist pump) where sheath leakage could result in serious harm or device malfunction in a critical patient population.
Plain-English summary
ABIOMED, Inc. is recalling the Impella CP Set (Pump Set Code 0048-0014, Introducer Product Code 0052-3046), a heart pump and accessories device. The recall affects approximately 35,430 units distributed worldwide, including nationwide in the US and internationally across 35 other countries.
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. Since 14Fr or 23Fr introducers are provided in every pump set, all current batches in the field are affected. These manufacturing issues are not visually detectable by the user.
Healthcare providers and patients using these devices should contact ABIOMED, Inc. for guidance on assessment and management options. The Agency has classified this as a Class I recall.
The recalled product
- Product
- ABIOMED Impella CP Set, Pump Set Code 0048-0014; containing Introducer Product Code 0052-3046. heart pump and accessories
- Manufacturer
- Abiomed, Inc.
- Hazard
- sheath-leakage
- device-malfunction
- 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 (5)
- Pump Set Code 0048-0014
- Introducer Product Code 0052-3046. GTIN: 00813502012873
- 00813502013344
- 00813502013368
- 04260113630280. All current batches in field.
Distribution
Distributed nationwide across the United States.
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