Food, drugs, devices › Vascutek, Ltd.
Device recall: Gelseal Straight Diameter 8mm Length 15cm. Vascular graft prosthesis is an implanted device intended to repair, replace,
FDA enforcement event 71305 is a device recall by Vascutek, Ltd. of Inchinnan, initiated 15 May 2015 and classified Class II, with 2 product records.
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 1,153 device enforcement events initiated in 2015 carry the same class.
Status: Terminated, terminated 20 Oct 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
"Product was labeled as a 30cm graft, when in fact the graft in the box was a 15cm graft."
Distribution
"Distributed in the state of Michigan (USA), and the countries of United Kingdom, Australia, Poland, and Germany."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1912-2015 | 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. | 12 | Class II | Terminated | 8 Jul 2015 |
| Z-1913-2015 | Gelseal Straight Diameter 8mm Length 30cm. 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. | 12 | Class II | Terminated | 8 Jul 2015 |
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 Jul 2014 | Gelweave (TM) Vascular Prostheses Manufactured by - VASCUTEK Ltd a TERUMO company | Device | Class II | 1 |
All 4 events for Vascutek, Ltd.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Product was labeled as a 30cm graft, when in fact the graft in the box was a 15cm graft."
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: "Distributed in the state of Michigan (USA), and the countries of United Kingdom, Australia, Poland, and Germany."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 20 Oct 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.