ViaPeel PTFE Peelable Introducer 5FR — Class II medical device recall Z-2781-2017
Terminated recall by Greatbatch Medical, reported 2017-08-09, distributed in NY. Greatbatch received complaints with the ViaPeel Introducer Sheath 5FR, of handles detaching during use.
| Recall number | Z-2781-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Greatbatch Medical, Plymouth, MN, United States |
| Recall initiated | 2016-11-11 |
| Classified | 2017-07-29 |
| Reported by FDA | 2017-08-09 |
| Terminated | 2017-11-03 |
| Distributed | NY |
| Quantity | 5,000 devices |
| Reason classes | device malfunction |
| Lot numbers | W3101005 |
| Model numbers | 10890-006 |
Product
ViaPeel PTFE Peelable Introducer 5FR, Part Number 10890-006
Reason for recall
Greatbatch received complaints with the ViaPeel Introducer Sheath 5FR, of handles detaching during use.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2781-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.