FDA Medical Device Recalls (openFDA)
Greatbatch Medical: ViaPeel PTFE Peelable Introducer 5FR, Part Number 10890-006
- Recall number
- Z-2781-2017
- Recalling firm
- Greatbatch Medical
- Product
- ViaPeel PTFE Peelable Introducer 5FR, Part Number 10890-006
- Status
- Terminated
- Initiated
- 2016-11-11
- Posted
- not on file
- Terminated
- 2017-11-03
- Reason
- Greatbatch received complaints with the ViaPeel Introducer Sheath 5FR, of handles detaching during use.
- Root cause
- Process control
- Action
- Consignee was sent via email on 11/11/2016 a Greatbatch "Urgent Medical Device Recall" letter dated November 2016. The letter described the product involved in the recall, Reason for Field Corrective Action, Risk to Health, Replacement Devices & Instructions to Customer. Advised consignees to quarantine the product, contact end users & complete and return the Field Recall Response Form to Stericycle at Greatbatch7893@stericycle.com or fax at 888-473-8015. For questions contact your local Greatbatch Medical representative, contact us at 1-763-951-8235, or e-mail us at FieldActionCenter@Greatbatch.com
- Quantity
- 5,000 devices
- Distribution
- NY
- Lot, serial or model codes
- Lot Number: W3101005
- 510(k) numbers
- ["K072248"]
- PMA numbers
- not on file
- Product code
- DYB
- Firm FEI
- 2183787
- Firm city
- Plymouth
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28