FDA Medical Device Recalls (openFDA)
Vascutek, Ltd.: Gelseal Straight Diameter 8mm Length 15cm. Vascular graft prosthesis is an implanted device intended to repair, replace, or bypass sections of native or artificial vessels, excluding coronary or cerebral vasculature, and to provide vascular access.
- Recall number
- Z-1912-2015
- Recalling firm
- Vascutek, Ltd.
- Product
- Gelseal Straight Diameter 8mm Length 15cm. Vascular graft prosthesis is an implanted device intended to repair, replace, or bypass sections of native or artificial vessels, excluding coronary or cerebral vasculature, and to provide vascular access.
- Status
- Terminated
- Initiated
- 2015-05-15
- Posted
- 2015-06-26
- Terminated
- 2015-10-20
- Reason
- Product was labeled as a 30cm graft, when in fact the graft in the box was a 15cm graft.
- Root cause
- Error in labeling
- Action
- On 5/15/2015, Vascutek issued a URGENT FIELD SAFETY NOTICE to their consignee informing them of the corrective action of the affected product. The information included details of the affected devices, including potential risks and actions to be taken by medical staff and distributors.
- Quantity
- 12
- Distribution
- Distributed in the state of Michigan (USA), and the countries of United Kingdom, Australia, Poland, and Germany.
- Lot, serial or model codes
- Product Code 431508, Batch 301509/01, Serial Numbers 0001515180, 0001515181, 0001515182, 0001515183, 0001515184, 0001515185, 0001515186, 0001515187, 0001515188, 0001515189, 0001515190, 0001515191
- 510(k) numbers
- not on file
- PMA numbers
- ["P890045"]
- Product code
- MAL
- 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