CLASS II Device recall · Reported 6 Oct 2021 · FDA Enforcement Report

The Instructions for Use (IFU) for: Carotid Patch recalled by Vascutek

Vascutek is recalling The Instructions for Use (IFU) for: Carotid Patch and Gelsoft Patch vascular patches, distributed in Puerto Rico. The recall was initiated on 8 Jul 2021 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesTo be reported.

Quantity recalled159 total vascular grafts and patches

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-2543-2021
FDA event ID: 88278
Recalling firm: Vascutek, Inchinnan, N/A
Classification: Class II
Status: Terminated
Recall initiated: 8 Jul 2021
FDA classified: 24 Sep 2021
Reported: 6 Oct 2021
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Other Reasons
Device type: Heart & Vascular Devices

Timeline

8 Jul 2021	Recall initiated by company
24 Sep 2021	Classified by FDA	+78 days
6 Oct 2021	Published in enforcement report	+12 days

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

Reason for recall

The devices contained the IFU for distribution to ROW (rest of world) consignees rather than U.S. consignees.

Product as listed by the FDA

The Instructions for Use (IFU) for: Carotid Patch and Gelsoft Patch vascular patches. FSN says Tapered Carotid Patch 920875t

Where it was distributed

Distribution was made to PR and Guam.

Puerto Rico

Questions about this recall

Why was it recalled?

The devices contained the IFU for distribution to ROW (rest of world) consignees rather than U.S. consignees.

Which lots are affected?

To be reported.

Where was it sold?

Distribution was made to PR and Guam.

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

Other products in this recall event

1 other product · FDA event 88278

This product is part of a recall event; the main page for the event is The Instructions for Use (IFU) for: Gelsoft Plus Bifurcate recalled.

Reported	Class	Recall	Company	Reason	Where
6 Oct 2021	CLASS II	The Instructions for Use (IFU) for: Gelsoft Plus Bifurcate recalled	Vascutek	Other	PR

More recalls from Vascutek

All 6

Reported	Class	Recall	Company	Reason	Where
11 Mar 2026Device	CLASS II	Gelsoft Plus recalled by Vascutek	Vascutek	Labeling Errors	Nationwide
6 Oct 2021Device	CLASS II	The Instructions for Use (IFU) for: Gelsoft Plus Bifurcate recalled	Vascutek	Other	PR
8 Jul 2015Device	CLASS II	Gelseal Straight Diameter Length Vascular graft prosthesis recalled	Vascutek	Packaging Defects	MI
8 Jul 2015Device	CLASS II	Gelseal Straight Diameter Length Vascular graft prosthesis recalled	Vascutek	Packaging Defects	MI
27 Aug 2014Device	CLASS II	Gelweave (TM) Vascular Prostheses recalled by Vascutek	Vascutek	Other	Nationwide

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