Food, drugs, devices › Vascutek, Ltd.
Device recall: Gelweave (TM) Vascular Prostheses Manufactured by - VASCUTEK Ltd a TERUMO company
FDA enforcement event 68952 is a device recall by Vascutek, Ltd. of Inchinnan, initiated 15 Jul 2014 and classified Class II, with 1 product record.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 91% of the 1,176 device enforcement events initiated in 2014 carry the same class.
Status: Terminated, terminated 19 Mar 2015. Initiation: voluntary: firm initiated. Vascutek, Ltd. has 4 enforcement events on this register, with a median of 2 product records per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Vascutek, Ltd., Inchinnan, United Kingdom.
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)."
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,…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2266-2014 | Gelweave (TM) Vascular Prostheses Manufactured by - VASCUTEK Ltd a TERUMO company | 63,162 | Class II | Terminated | 27 Aug 2014 |
Context
Other enforcement events for Vascutek, Ltd.
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 18 Dec 2025 | Gelsoft Plus, REF: 635024PE, 631514PE, 631222PE, 633008PE, 633010PE, 633007PE, 636010PE, 632522PE, 633012PE, 635018PE, 6 | Device | Class II | 1 |
| 8 Jul 2021 | The Instructions for Use (IFU) for: Gelsoft Plus Bifurcate, Gelsoft Plus Ax-Fem, GelsoftPlus ERS Ax-Fem, Gelweave Straig | Device | Class II | 2 |
| 15 May 2015 | Gelseal Straight Diameter 8mm Length 15cm. Vascular graft prosthesis is an implanted device intended to repair, replace, | Device | Class II | 2 |
All 4 events for Vascutek, Ltd.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall 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)."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "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,…"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 19 Mar 2015. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.