ABIOMED Insertion Kit heart pump accessories introducer sheath leakage
Abiomed is recalling ABIOMED Insertion Kits 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.
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: This is an FDA Class I recall of a heart pump device. Under the rubric, FDA Class I recalls must score no lower than 4 (Severe), regardless of whether illness has been reported.
Plain-English summary
Abiomed, Inc. is recalling ABIOMED Insertion Kits with Pump Set Code 0052-0011-JP and Introducer Product Code 0052-3006-JP. The recall affects 117 units distributed worldwide.
The recalled kits contain a potential manufacturing defect that may cause introducer sheath leakage from under the sheath cap and along hub score lines in both 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user. Because 14Fr or 23Fr Introducers are provided in every pump set, all current batches in the field are affected.
The ABIOMED Insertion Kits have been distributed in the US and internationally, including to Australia, Austria, Belgium, Brazil, Brunei, Canada, China, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, Ireland, Israel, Italy, Japan, Kuwait, Luxembourg, Malaysia, Mexico, Netherlands, Norway, Panama, Poland, Saudi Arabia, Serbia, Slovenia, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, United Arab Emirates, and United Kingdom.
Users should contact Abiomed, Inc. for instructions regarding the recalled product.
The recalled product
- Product
- ABIOMED Insertion Kit, Pkgd, JP, Pump Set Code 0052-0011-JP; containing Introducer Product Code 0052-3006-JP. heart pump and accessories
- Manufacturer
- Abiomed, Inc.
- Affected units
- 117
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 0052-0011-JP
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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