Gelseal Straight Diameter 8mm Length 30cm recallZ-1913-2015 · Vascutek, Ltd. · initiated May 15, 2015
Class II Terminated All recalls posted in June 2015
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Vascutek, Ltd. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Product was labeled as a 30cm graft, when in fact the graft in the box was a 15cm graft.
FDA root cause category: Error in labeling
What the company is doing
On 5/15/2015, Vascutek issued a URGENT FIELD SAFETY NOTICE to their consignee informing them of the corrective action of the affected product. The information included details of the affected devices, including potential risks and actions to be taken by medical staff and distributors.
Recall details
- Recall number
- Z-1913-2015
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- May 15, 2015
- Posted by the FDA
- Jun 26, 2015
- Recalling firm
- Vascutek, Ltd.
- Quantity
- 12
- Product code
- MAL
- FDA submissions
- P890045
- Distribution
- Distributed in the state of Michigan (USA), and the countries of United Kingdom, Australia, Poland, and Germany.
Product description
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.
Code information (models, lots, serial numbers)
Product Code 433008, Batch 301509/02, Serial Numbers 0001515204, 0001515205, 0001515206, 0001515207, 0001515208, 0001515209, 0001515210, 0001515211, 0001515212, 0001515213, 0001515214, 0001515215
Other devices under the same FDA submission
2 devices cleared under P890045 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Gelseal™ 435028Vascutek Ltd · GRAFT, VASCULAR, SYNTHETIC/BIOLOGIC COMPOSITE1 report
- Gelseal™ 431508Vascutek Ltd · GRAFT, VASCULAR, SYNTHETIC/BIOLOGIC COMPOSITE1 report
Other products in the same recall event
The FDA groups related products into one recall event (event 71305).
- Z-1912-2015 · TerminatedGelseal Straight Diameter 8mm Length 15cm. Vascular graft prosthesis is an implanted device intended to repair, replace, or bypass sections of native or artificial vessels, exclud…
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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