Device product
ViaPeel PTFE Peelable Introducer 5FR, Part Number 10890-006
Z-2781-2017
Product summary
- Event
- Event 76701
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5,000 devices
- Official record key
device-enforcement:Z-2781-2017
Official wording
Reason: Greatbatch received complaints with the ViaPeel Introducer Sheath 5FR, of handles detaching during use.
Code information: Lot Number: W3101005
Distribution pattern: NY
Derived failure modes
-
Unknown
Greatbatch received complaints with the ViaPeel Introducer Sheath 5FR, of handles detaching during use.