FDA Medical Device Recalls (openFDA)
Terumo Cardiovascular Systems Corporation: Vascutek Gelsoft Vascular Graft (peripheral) Labeling reads in part, "***Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis***STRAIGHT***STERILE***EO***Item No: 631508***Diameter 8mm***Usable Length 15cm***Manufactured By***VASCUTEK Ltd. a TERUMO Company Newmains Avenue Inchinnan, Renfrewshire PA4 9RR Scotland***" The Vascutek Gelsoft Vascular Prosthesis is a gelatin-sealed, woven polyester graft indicated for abdominal and peripheral vascular repair, i.e. replacement or bypass in aneurysmal and occlusive disease of arteries
- Recall number
- Z-0336-2014
- Recalling firm
- Terumo Cardiovascular Systems Corporation
- Product
- Vascutek Gelsoft Vascular Graft (peripheral) Labeling reads in part, "***Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis***STRAIGHT***STERILE***EO***Item No: 631508***Diameter 8mm***Usable Length 15cm***Manufactured By***VASCUTEK Ltd. a TERUMO Company Newmains Avenue Inchinnan, Renfrewshire PA4 9RR Scotland***" The Vascutek Gelsoft Vascular Prosthesis is a gelatin-sealed, woven polyester graft indicated for abdominal and peripheral vascular repair, i.e. replacement or bypass in aneurysmal and occlusive disease of arteries
- Status
- Terminated
- Initiated
- 2013-10-23
- Posted
- 2013-11-18
- Terminated
- 2014-02-27
- Reason
- Terumo Cardiovascular Systems (Terumo CVS) became aware of a customer complaint that a 15mm x 8mm Gelsoft graft was received which the customer believed was a 15mm x 6mm Gelsoft graft unit. The manufacturer confirmed a batch of product code 631508 was incorrectly labeled.
- Root cause
- Error in labeling
- Action
- Terumo CVS called affected consignees (via telephone)on 10/23/2013 of this device removal. Terumo CVS advised users to discontinue use and return all affected grafts in inventory. Terumo will replace or issue credit for returned grafts. Terumo provided consignees with the reason of the removal, potential hazard, and description of affected product. Terumo addressed any questions from the consignees. Consignees with questions were instructed to contact Terumo CVS Customer Service at 800-521-2818. For questions regarding this recall call 734-741-6173.
- Quantity
- 9
- Distribution
- US Distribution in the states of: NC and CA.
- Lot, serial or model codes
- Catalog Number 631508 Serial Numbers: 0001765391, 0001765392, 0001765393, 0001765394, 0001765395, 0001765396, 0001765397, 0001765398, 0001765399
- 510(k) numbers
- ["K990503"]
- PMA numbers
- not on file
- Product code
- DSY
- Firm FEI
- 1828100
- Firm city
- Ann Arbor
- Firm state
- MI
- Firm country
- not on file
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