FDA Medical Device Recalls (openFDA)
Vascutek, Ltd.: The Instructions for Use (IFU) for: Carotid Patch and Gelsoft Patch vascular patches. FSN says Tapered Carotid Patch 920875t
- Recall number
- Z-2543-2021
- Recalling firm
- Vascutek, Ltd.
- Product
- The Instructions for Use (IFU) for: Carotid Patch and Gelsoft Patch vascular patches. FSN says Tapered Carotid Patch 920875t
- Status
- Terminated
- Initiated
- 2021-07-08
- Posted
- not on file
- Terminated
- 2024-08-19
- Reason
- The devices contained the IFU for distribution to ROW (rest of world) consignees rather than U.S. consignees.
- Root cause
- Under Investigation by firm
- Action
- The recalling firm sent emails on 7/8/2021 to the two distributors that contained the Field Safety Notice and the correct IFU to be supplied with products distributed to the United States.
- Quantity
- 159 total vascular grafts and patches
- Distribution
- Distribution was made to PR and Guam.
- Lot, serial or model codes
- To be reported.
- 510(k) numbers
- K963611, K972201
- PMA numbers
- not on file
- Product code
- DXZ
- Firm FEI
- 3002808437
- Firm city
- Inchinnan
- Firm state
- not on file
- Firm country
- United Kingdom
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