Vascutek Gelseal Vascular Grafts Recalled for Incorrect Length Labeling
Vascutek is recalling 12 Gelseal vascular grafts labeled as 30cm but actually 15cm. The devices were distributed in Michigan and four other countries.
The agency’s classification
FDA (Devices): Class II
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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a labeling error (incorrect length) without reported injuries or illnesses, fitting the criteria for moderate severity.
Plain-English summary
Vascutek, Ltd. is recalling 12 units of Gelseal Straight Diameter 8mm vascular graft prostheses. The recall is due to a labeling error where the product was labeled as a 30cm graft, but the actual graft inside the box was 15cm.
The affected devices are identified by Product Code 433008, Batch 301509/02, and specific serial numbers ranging from 0001515204 to 0001515215. These devices were distributed in the state of Michigan, United Kingdom, Australia, Poland, and Germany.
Healthcare providers and patients should check their inventory or medical records for these specific serial numbers. If the affected devices are found, they should be removed from use and returned to the manufacturer or disposed of according to local regulations. This recall is classified as Class II by the FDA.
The recalled product
- Product
- 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.
- Manufacturer
- Vascutek, Ltd.
- Category
- Medical Device — Vascular Graft
- Hazard
- Affected units
- 12
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (14)
- Product Code 433008
- Batch 301509/02
- Serial Numbers 0001515204
- 0001515205
- 0001515206
- 0001515207
- 0001515208
- 0001515209
- 0001515210
- 0001515211
- 0001515212
- 0001515213
- 0001515214
- 0001515215
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 2 recalled by Vascutek, Ltd. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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