ABIOMED Impella CP Introducer Kit 14Fr heart pump safety recall
ABIOMED Impella CP Introducer Kit 14Fr is being recalled due to a potential for introducer sheath leakage from under the sheath cap and along hub score lines. The manufacturing defect is not visually detectable by users.
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: This is an FDA Class I recall of a critical cardiac support medical device. Class I recalls by definition carry risk of serious harm or death; the introducer sheath leakage in a heart pump could result in device failure during life-sustaining therapy, meeting the "Severe" criterion for medical device recalls with structural/functional defects affecting patient safety.
Plain-English summary
ABIOMED, Inc. is recalling the Impella CP Introducer Kit 14 Fr, 13 and 25 cm (Pump Set Code 1000550, Introducer Product Code 0052-3046) worldwide due to a potential for introducer sheath leakage from under the sheath cap and along the hub score lines. The manufacturing issues identified in 14Fr and 23Fr Introducers are not visually detectable by the user, and these introducers are provided in every pump set.
A total of 846 units have been distributed worldwide, including throughout the US and to 34 additional countries including Australia, Canada, Japan, China, and countries across Europe and the Middle East. All current batches in the field are affected.
Patients and healthcare providers using affected Impella CP Introducer Kits should contact ABIOMED, Inc. for further guidance. The sheath leakage could result in device malfunction during cardiac support therapy.
The recalled product
- Product
- ABIOMED Impella CP Introducer Kit 14 Fr, 13 and 25 cm, Pump Set Code 1000550, containing Kit, 14Fr Introducer, 13cm&25cm, Sterile, Introducer Product Code 0052-3046. heart pump and accessories
- Manufacturer
- Abiomed, Inc.
- Affected units
- 846
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 1000550
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.
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