Z-0336-2014Class II

Vascutek Gelsoft Vascular Graft (peripheral) Labeling reads in part, "***Gelsoft Gelatin Impregnated Knitted...

Name: Z-0336-2014 Vascutek Gelsoft Vascular Graft (peripheral) Labeling reads in part, "***Gelsoft Gelatin Impregnated Knitted...
Creator: Terumo Cardiovascular Systems Corporation
Published: 2013-10-23
License: https://open.fda.gov/license/

Terumo Cardiovascular Systems Corporation / initiated 2013-10-23 / Terminated / root cause: labeling and UDI

FDA source

Terumo Cardiovascular Systems Corporation began a recall of Vascutek Gelsoft Vascular Graft (peripheral) Labeling reads in part, "***Gelsoft Gelatin Impregnated Knitted Vascular... on 2013-10-23. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0336-2014
Classification: Class II
Status: Terminated
Initiated: 2013-10-23
Posted: 2013-11-18
Terminated: 2014-02-27
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
Product code: DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
Reason for recall: 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 tag: labeling and UDI
FDA 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 in commerce: 9
Distribution: US Distribution in the states of: NC and CA.
Product codes and lots: Catalog Number 631508 Serial Numbers: 0001765391, 0001765392, 0001765393, 0001765394, 0001765395, 0001765396, 0001765397, 0001765398, 0001765399

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0336-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0336-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-27	2013-11-18

Product code DSY

K990503Class IISulzer Vascutek Gelsoft Vascular ProsthesisSulzermedica / cleared 1999-12-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)