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.
What this means for you
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: The recall involves a medical device used in vascular reconstruction where a defect in surface identification could lead to improper application or handling, representing a risk of harm even though specific injuries are not reported in the source text.
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 st
- 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.
Related recalls
Same manufacturer · Synovis Surgical Innovations, Inc.
See all →- ModerateSynovis Recalls Dura-Guard and Vascu-Guard Patches Due to Shipping Errors
FDA (Devices) · 2013-11-27
- ModerateSynovis Recalls Vascu Guard and Dura-Guard Patches Due to Shipping Configuration Issues
FDA (Devices) · 2013-11-27
Same hazard · mis labeling
See all →- ModerateMedline Trach Tube Kit Recalled for Component Labeling Discrepancy
FDA (Devices) · 2026-09-02
- ModerateAVID Medical Recalls Halyard Total Joint Kits for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- ModerateOlympus Recalls PowerSeal Sealer Due to Incorrect Outer Box Labeling
FDA (Devices) · 2026-09-02
- HighSura Tanmen Ramen Noodles Recalled for Undeclared Fish Allergens
FDA (Food) · 2026-09-02
- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-09-02