Reported Jul 19, 2023 · Ongoing
Abiomed 14Fr Low Profile Introducer Set, Product Number 1000457
Abiomed, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Abiomed, Inc. · 24 Cherry Hill Dr · Danvers, MA · 01923-2575
Is this the product you have?
Abiomed 14Fr Low Profile Introducer SetProduct Number 1000457
- Lot codes and dates
- UDI-DI00813502013252
- Lot Numbers
17270331725590
- Amount recalled
- 37 units
Where it was sold
Why it was recalled
There was one complaint that the sidearm of the device detached during explant of a pump. When the sidearms are subjected to heat, humidity and articulation, a silicone oil contaminant that was unintentionally introduced during manufacturing at the joint between the sidearm and the hub may cause the joint to detach.
This product could cause temporary or reversible health problems — stop using it.
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