A change in packaging caused a Class I recall of Baxter’s Vascu-Guard peripheral patch. The recall, which was initiated on May 2, 2015, affects the following four models of the Vascu-Guard Peripheral Vascular Patch: VASCU-GUARD TS 1x6cm (Product Code: 1504026), VASCU-GUARD TS 0.8x8cm (Product Code: 1504028), VASCU-GUARD TS 1x10cm (Product Code: 1504030), VASCU-GUARD TS 2x9cm (Product Code: 1504032).
According to a statement by the U.S. Food and Drug Administration (FDA), the recalled device “is used to rebuild peripheral blood vessels such as the carotid in the neck and the renal in the kidneys. It is also used in arteriovenous access revisions.” Qmed reports that a change in foil pouch caused the smooth side of the patch to be too rough, making it hard to surgeons to tell the difference. Patients may suffer from embolism, reduced blood flow, stroke, organ failure or death if the rough side of the patch is implanted incorrectly, FDA says.
Class I recalls are the most serious type of recall. This designation means that exposure to the drug or medical device can reasonably lead to serious health consequences or death.
According to the FDA, the risk of blood clots is higher in patients who need smaller arteries repaired. This is because the blood flow is slowed in smaller vessels. Additional, blood clots are more likely to occur in patients who have blood disorders resulting in excessive clots.
The FDA received 51 complaints from Baxter over the patches. Adverse effects include postoperative thrombosis and stroke. John O’Malley, spokesman for Baxter, told Qmed “Baxter is in the process of an in-depth investigation, and will share additional information as it becomes available,”