UPDATED June 5, 2015, with details from the FDA.
The FDA has labeled it as a Class I recall, the most serious type of recall issued by the federal watch dog, which indicates that “there is a reasonable probability that use of these products will cause serious adverse health consequences or death.”
Deerfield Park, Ill.-based Baxter said it received complaints over the patches from customers who were unable to distinguish the smooth and rough surfaces of the patch as described in the instructions. The deviation is due to a new packaging configuration, the company said.
Incorrect orientation upon implantation, with the rough side towards the bloodstream, could increase the risk of vessel thrombosis and/or embolisms, the company said in a release published by the FDA.
The FDA added that the defect “may expose patients to significant health risks, including the movement of blood clots into the blood stream (embolism), reduced blood flow, stroke, organ failure, or death.”
The recalled codes are 1504026, 1504028, 1504030 and 1504032, covering 1x6cm, 0.8x8cm, 1x10cm and 2x9cm sizes of the Vascu-Guard.
New information from the FDA indicates that the recall affects 3,974 units distributed within the U.S. to 70 customers. The patches were manufactured between January 19 and May 1, 2015, and distributed between March 16 and May 1. No distribution outside the U.S. was indicated by the FDA.
The FDA said it has received 51 complaints related to the issue, and one serious injury. The Deerfield, Ill.-based healthcare giant said 1 incident included a postoperative thrombosis and stroke. Baxter said it will continue to investigate reports, but claims that no causal association with the patch has been established.
The company’s patch is designed to be used in vascular reconstruction, including carotid, renal, iliac, femoral, profund and tibial blood vessels and arteriovenous access revisions, Baxter said.