Carotid and Gelsoft vascular patches recalled for incorrect instructions
Vascutek vascular patches were distributed with rest-of-world instructions instead of U.S. instructions. The 159 units distributed to Puerto Rico and Guam have incorrect Instructions for Use for U.S. use.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Vascular patches are high-risk medical devices where incorrect instructions could affect proper use. Although no injuries have been reported, the mismatch between device instructions and the U.S. market constitutes a risk-of-harm situation without yet-reported injury.
Plain-English summary
Vascutek, Ltd. has recalled Carotid Patch and Gelsoft Patch vascular patches due to incorrect Instructions for Use. The recalled devices, totaling 159 units, were distributed to Puerto Rico and Guam. The devices were packaged with instructions intended for rest-of-world markets rather than U.S. consignees.
Vascular patches are medical devices used in cardiovascular procedures. Correct instructions are critical for proper device preparation and use. Healthcare facilities and medical professionals who received these devices should verify that the Instructions for Use provided are appropriate for U.S. use and contact Vascutek for correct U.S. documentation if needed. The FDA has classified this as a Class II recall.
The recalled product
- Product
- The Instructions for Use (IFU) for: Carotid Patch and Gelsoft Patch vascular patches. FSN says Tapered Carotid Patch 920875t
- Manufacturer
- Vascutek, Ltd.
- Affected units
- 159
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 (1)
- To be reported.
Distribution
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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