ABIOMED Impella 5.5 Heart Pump Introducer Sheath Leakage Risk Recall
Abiomed is recalling the Impella 5.5 Smart Assist Set heart pump due to potential leakage from introducer sheaths. The defect is not visually detectable and affects all affected pump sets worldwide.
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 implantable medical device (heart pump). Class I recalls meet the "Severe" threshold (minimum score 4) per the rubric, particularly for life-sustaining devices where leakage could compromise device function or patient safety.
Plain-English summary
Abiomed, Inc. is recalling the ABIOMED Impella 5.5 Smart Assist Set (Pump Set Codes 1000211, 1000212) due to a potential for introducer sheath leakage. The leakage may occur under the sheath cap and along the hub score lines in both 14Fr and 23Fr introducers. Since 14Fr or 23Fr introducers are provided in every pump set, all units are potentially affected.
The manufacturing issues causing this leakage are not visually detectable by users, meaning affected units cannot be identified by inspection alone. A total of 383 units have been distributed worldwide, including across the US and to 33 additional countries including Australia, Canada, Japan, and multiple European nations.
Patients and healthcare facilities using the affected Impella 5.5 pump sets should contact Abiomed, Inc. for guidance on remediation options. This is a Class I recall by the FDA.
The recalled product
- Product
- ABIOMED Impella 5.5 Smart Assist Set, JP, Pump Set Codes 1000211, 1000212; containing Introducer Product Code 0052-3006-JP. heart pump and accessories
- Manufacturer
- Abiomed, Inc.
- Hazard
- device-leakage
- introducer-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 (2)
- Pump Set Codes 1000211
- 1000212
Distribution
Distributed nationwide across the United States.
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