Z-2781-2017Class II

ViaPeel PTFE Peelable Introducer 5FR, Part Number 10890-006

Name: Z-2781-2017 ViaPeel PTFE Peelable Introducer 5FR, Part Number 10890-006
Creator: Greatbatch Medical
Published: 2016-11-11
License: https://open.fda.gov/license/

Greatbatch Medical / initiated 2016-11-11 / Terminated / root cause: manufacturing process

FDA source

Greatbatch Medical began a recall of ViaPeel PTFE Peelable Introducer 5FR, Part Number 10890-006 on 2016-11-11. FDA classified it as Class II and gives the reason as "Greatbatch received complaints with the ViaPeel Introducer Sheath 5FR, of handles detaching during use". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2781-2017
Classification: Class II
Status: Terminated
Initiated: 2016-11-11
Posted: 2017-07-29
Terminated: 2017-11-03
Recalling firm: Greatbatch Medical
Product: ViaPeel PTFE Peelable Introducer 5FR, Part Number 10890-006
Product code: DYB Introducer, Catheter
Reason for recall: Greatbatch received complaints with the ViaPeel Introducer Sheath 5FR, of handles detaching during use.
Root cause tag: manufacturing process
FDA 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 [email protected] 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 [email protected]
Quantity in commerce: 5,000 devices
Distribution: NY
Product codes and lots: Lot Number: W3101005

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2781-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2781-2017	Class II	Terminated	Voluntary: Firm initiated	2017-08-09	2017-07-29

Product code DYB

K072248Class IIViapeel Peelable IntroducerEnpath Medical, Inc. / cleared 2007-11-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)