Class II — Greatbatch Medical
| Recalling firm | GREATBATCH MEDICAL |
|---|---|
| Registered facility | View this company's 4 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Greatbatch received complaints with the ViaPeel Introducer Sheath 5FR, of handles detaching during use. |
| Product | ViaPeel PTFE Peelable Introducer 5FR, Part Number 10890-006 |
| Quantity | 5,000 devices |
| Distribution | NY |
| Initiated | 2016-11-11 |
| Classified | 2017-07-29 |
| Terminated | 2017-11-03 |
| Recall number | Z-2781-2017 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Greatbatch Medical (Z-2781-2017).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/76701/
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