Synovis Recalls Vascu-Guard Patches Due to Surface Identification Issues
Synovis is recalling specific Vascu-Guard Peripheral Vascular Patch codes because users reported difficulty distinguishing the smooth from the rough surface.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Baxter healthcare is recalling specific product codes of Vascu-Guard Peripheral Vascular Patch due to complaints received for difficulty in distinguishing the smooth from rough surface."
Plain-English summary
Synovis Surgical Innovations, Inc. is recalling specific product codes of the Vascu-Guard Peripheral Vascular Patch. The recall involves 3,974 units distributed nationwide. The affected product codes are 1504026, 1504028, 1504030, and 1504032, corresponding to sizes 1x6cm, 0.8x8cm, 1x10cm, and 2x9cm.
The recall was initiated due to complaints regarding difficulty in distinguishing the smooth surface from the rough surface of the patch. The Vascu-Guard patch is intended for use in peripheral vascular reconstruction, including carotid, renal, iliac, femoral, profunda, and tibial blood vessels, as well as arteriovenous access revisions.
Healthcare providers and facilities should check their inventory for the specific product codes listed above. If these products are found, they should be removed from use and returned to the manufacturer or disposed of according to local regulations.
The recalled product
- Product
- Synovis VASCU-GUARD Peripheral Vascular Patch in the following sizes and product codes: 1x6cm, product code 1504026, 0.8x8cm, product code 1504028, 1x10cm, product code 1504030, and 2x9cm, product code 1504032. VASCU-GUARD is packaged between two pieces of foam within a double…
- Manufacturer
- Synovis Surgical Innovations, Inc.
- Hazard
- Affected units
- 3,974
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)
- all lot numbers
Distribution
Distributed nationwide across the United States.
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