Abiomed 14Fr Low Profile Introducer Set recall
Abiomed 14Fr Low Profile Introducer Set, Product Number 1000457
Why was Abiomed 14Fr Low Profile Introducer Set 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI-DI: 00813502013252; Lot Numbers: 1727033, 1725590
- Product
- Abiomed 14Fr Low Profile Introducer Set, Product Number 1000457
- Recalling firm
- Abiomed, Inc.
- Quantity
- 37 units
- Distribution
- US Nationwide distribution in the states of MN, NJ, TN.
- Recall date
- July 19, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)