Z-2266-2014Class II

Gelweave (TM) Vascular Prostheses Manufactured by - VASCUTEK Ltd a TERUMO company

Name: Z-2266-2014 Gelweave (TM) Vascular Prostheses Manufactured by - VASCUTEK Ltd a TERUMO company
Creator: Vascutek, Ltd.
Published: 2014-07-15
License: https://open.fda.gov/license/

Vascutek, Ltd. / initiated 2014-07-15 / Terminated / root cause: labeling and UDI

FDA source

Vascutek, Ltd. began a recall of Gelweave (TM) Vascular Prostheses Manufactured by - VASCUTEK Ltd a TERUMO company on 2014-07-15. FDA classified it as Class II and gives the reason as "The cautery that is provided with the Gelweave graft in the box has a shorter shelf life indicated on its label, versus that of the graft (4 years and 5 years, respectively)". 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-2266-2014
Classification: Class II
Status: Terminated
Initiated: 2014-07-15
Posted: 2014-08-18
Terminated: 2015-03-19
Recalling firm: Vascutek, Ltd.
Product: Gelweave (TM) Vascular Prostheses Manufactured by - VASCUTEK Ltd a TERUMO company
Product code: DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
Reason for recall: The cautery that is provided with the Gelweave graft in the box has a shorter shelf life indicated on its label, versus that of the graft (4 years and 5 years, respectively).
Root cause tag: labeling and UDI
FDA root cause: Incorrect or no expiration date
Action: Vascutek sent an Urgent Field Safety Notice dated July 15, 2014, to all affect customers. The letter identified the product the problem and the action needed to be taken by the customer. User Instructions: A. Vascutek advises that you ensure suitable equipment is available prior to implantation to trim the graft if required. B. For product received with a cautery in the interim, Vascutek request that you check the shelf life of each product before every operation. If you find that the cautery is out of date, remove and discard the cautery. If you require an appropriate cautery supplied as a separate item, please contact your local sales representative for a referral. C.Vascutek are taking this opportunity to reinforce the cautions from the Gelweave TM Vascular Prostheses IFU regarding soaking of the graft in saline to prevent focal burning if a cautery is to be used. This statement is already included in the IFU and now appears in bold, red font to ensure appropriate awareness. This notice needs to be passed on to all persons who need to be aware within your organization or to any organization where the devices have been transferred or distributed. Please maintain awareness of this Field Safety Notice while all actions are taken in your organization and until these products are provided without the cautery. Please return the User Return Slip by e-mail or fax to the Distributor's address given on page 3. This action by Vascutek Ltd. is being taken with the knowledge of the National Competent Authority Medicines and Healthcare Products Regulatory Agency (MHRA). If you have any further questions or comments, please do not hesitate to contact us at [email protected]. Return Completed Form immediately fax to (734) 741-6149. If required, your Vascutek Ltd. representative can discuss and provide more information on the use of cautery with Vascutek products. For further questions call (800) 262-3304 ext. 6056
Quantity in commerce: 63,162
Distribution: Nationwide Distribution including the states of : AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI and WV.
Product codes and lots: 731030, 731032, 731034, 731036,731038, 731206, 731218, 731220, 731222, 731224, 731226, 731228, 731407, 731506, 731507, 731508, 731509, 731510, 731512, 731514, 731516, 731608, 731809, 732010, 732030, 732032, 732034, 732038, 732211, 732412, 732518, 732520, 732522, 732524, 732526, 732528, 733006, 733007, 733008, 733010, 733012, 733014, 733016, 733018, 733020, 733022, 733024, 733026, 733028, 733030, 733032, 733034, 733036, 733038, 733040, 733042, 734030, 734032, 734034, 734036, 734038, 735018, 735020, 735022, 735024, 735026, 735028, 736006, 736007, 736008, 736010, 736012, 736014, 736016, 736018, 736020, 736022, 736024, 736026, 736028, 736030, 736032, 736034, 736036, 736038, 731206/10/10, 731206/10/10RM, 731206/7, 731407/10/10, 731407/10/10RM, 731407/6X2RM, 731407/7, 731608/10/10, 731608/10/10RM, 731608/6, 731608/7, 731608/7X2RM, 731608/8/10, 731608/8/10RM, 731809/6, 732010/6, 732412/6, 7330303BL, 7330323BL, 7330343BL, 7330363BL, 7330383BL

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2266-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2266-2014	Class II	Terminated	Voluntary: Firm initiated	2014-08-27	2014-08-18

Product code DSY

The FDA recall record names no cleared device, and no clearance has been matched to it.

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)