After customer complaints of difficulties distinguishing the smooth from the rough surface of the Vascu-Guard Peripheral Vascular Patch, Baxter International has announced the voluntary recall of four product codes of the vascular patch.
The Vascu-Guard Peripheral Vascular Patch is intended for use in peripheral vascular reconstruction including carotid, renal, iliac, femoral, profunda, and tibial blood vessels and arteriovenous access revisions.
According to the recall notice, Baxter said there is a deviation in the surface texture of the vascular patch in a new packaging configuration. If the rough side of the patch faces toward the bloodstream, this correct may increase the risk of vessel thrombosis and/or embolism, which can lead to serious complications including stroke. The Food and Drug Administration (FDA) has designated this a Class I recall—the most serious recall category. Class I recalls are reserved for situations in which there is a reasonable probability that use of the product will cause serious adverse health consequences or death.
The following four product codes are affected by this recall: 1504026 VASCU-GUARD TS 1x6cm; 1504028 VASCU-GUARD TS 0.8x8cm; 1504030 VASCU-GUARD TS 1x10cm; and 1504032 VASCU-GUARD TS 2x9cm.
The FDA advises health care facilities to:
- Stop using the recalled patches
- Remove all recalled devices from inventory
- Return the patches to Baxter Healthcare
Any patient who has experienced a problem that may be related to the recalled patch should contact a doctor or other health care provider immediately.
Health care facilities should contact Baxter Healthcare Center for at 888-229-0001 to arrange for return of the patches. Any questions about the recall can be directed Baxter at 1-800-422-9837.
Baxter notes that the patch packaged in a plastic jar filled with sterile water and 1% propylene oxide is not affected by the recall and can still be ordered.
Health care professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program: www.fda.gov/MedWatch/report.