CLASS II Device recall · Reported 9 Aug 2017 · FDA Enforcement Report

ViaPeel PTFE Peelable Introducer recalled by Greatbatch Medical

Greatbatch Medical is recalling ViaPeel PTFE Peelable Introducer, distributed in New York. The recall was initiated on 11 Nov 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Number: W3101005

Quantity recalled5,000 devices

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2781-2017
FDA event ID: 76701
Recalling firm: Greatbatch Medical, Plymouth, MN
Classification: Class II
Status: Terminated
Recall initiated: 11 Nov 2016
FDA classified: 29 Jul 2017
Reported: 9 Aug 2017
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Other Reasons
Device type: Heart & Vascular Devices

Timeline

11 Nov 2016	Recall initiated by company
29 Jul 2017	Classified by FDA	+260 days
9 Aug 2017	Published in enforcement report	+11 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Greatbatch received complaints with the ViaPeel Introducer Sheath 5FR, of handles detaching during use.

Product as listed by the FDA

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

Where it was distributed

New York

Questions about this recall

Is ViaPeel PTFE Peelable Introducer recalled?

Yes. Greatbatch Medical recalled ViaPeel PTFE Peelable Introducer on 11 Nov 2016. The recall is Class II and its status is Terminated. Recall number Z-2781-2017.

Why was it recalled?

Greatbatch received complaints with the ViaPeel Introducer Sheath 5FR, of handles detaching during use.

Which lots are affected?

Lot Number: W3101005

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Greatbatch Medical

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22 Feb 2017Device	CLASS II	Offset Reamer Handle, T5766 recalled by Greatbatch Medical	Greatbatch Medical	Device Malfunction	Nationwide
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30 Nov 2016Device	CLASS II	Greatbatch Stiffer Coaxial Micro-Introducer recalled	Greatbatch Medical	Foreign Material	NY, TX

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