FDA Device recall Z-2781-2017
ViaPeel PTFE Peelable Introducer 5FR, Part Number 10890-006
- FDA Device
- Class II
- terminated
- Published 2017-08-09
On 2017-08-09 the FDA classified a Class II recall of ViaPeel PTFE Peelable Introducer 5FR, Part Number 10890-006 by Greatbatch Medical, citing greatbatch received complaints with the ViaPeel Introducer Sheath 5FR, of handles detaching during use.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2781-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-11-11 |
| Published | 2017-08-09 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Greatbatch Medical |
| Distribution | NY |
Product
ViaPeel PTFE Peelable Introducer 5FR, Part Number 10890-006
Reason
Greatbatch received complaints with the ViaPeel Introducer Sheath 5FR, of handles detaching during use.
Identifiers
| code_info | Lot Number: W3101005 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2781-2017%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.