Baxter Healthcare Corporation issued a recall1 of the VASCU-GUARD Peripheral Vascular Patch (also referred to as the VASCU-GUARD patch) after 51 complaints of difficulty in distinguishing the smooth from rough surface of the product, which is critical for correct implantation. If this product is implanted incorrectly, there is an increased risk of vessel thrombosis (the formation of a blood clot in a blood vessel) and/or embolism (a blood clot travels in the blood stream and gets stuck, causing potentially dangerous blockage).

Stroke, Heart Attack  Possible

According to the company press release 2 regarding this recall:

To date, Baxter has received a limited number of adverse event reports, including postoperative thrombosis and stroke, in which the recalled codes have been used.

Blood Clot Wrongful DeathOur job as attorneys is to prove that these “adverse events” are caused by the recalled patch. This is called “causation”, and companies have teams of lawyers whose job it is to prove there was was no causation. Our lawyers have fought these battles many times and won compensation for clients. You can click here now for a free consultation regarding a lawsuit against Baxter for personal injury or wrongful death.

Blood clots can cause stroke, heart attack and damage to other organs. In some cases, particularly with stroke clot in the brain) and pulmonary embolism (clot in the lung), the patient does not survive.

People at highest risk include:

  • Patients who need repair of smaller arteries; and
  • Patients who have blood disorders where excessive blood clots form.

Why is It Hard to Tell the Rough Side from the Smooth?

According to Baxter, a change in packaging caused the smooth surface of the patch to be too rough, as the company’s press release states: “This is due to a deviation in the surface texture of the vascular patch in a new packaging configuration.”

The product was designed to have the rough side to the patch implanted in a specific way. If this is not done correctly, blood clots (thrombus) may form on the patch. These clots may stay where they were formed, deep in the vein (“deep vein thrombosis”, also known as DVT) or they may travel to any part of the body in the blood stream. The damage possible depends on where they go.

What VASCU-GUARD Peripheral Vascular Patch Have Been Recalled?

Surgeons, hospitals and surgery outpatient clinics have been contacted regarding this recall. Patients may not have been notified. Therefore, if you have had surgery for any of the following, you should know that you are at risk:

  • Peripheral vascular reconstruction, including carotid (neck), renal (kidney), iliac (pelvis), femoral (thigh), profunda (deep vein in the thigh), and tibial (lower leg) blood vessels;
  • Arteriovenous access (used for dialysis) revisions.

The specific products recalled include the following:

  • VASCU-GUARD TS 1x6cm – 1504026;
  • VASCU-GUARD TS 0.8x8cm – 1504028;
  • VASCU-GUARD TS 1x10cm – 1504030; and
  • VASCU-GUARD TS 2x9cm – 1504032.

Additional information includes:

  • Manufacturing dates: January 19,2015 to May 1, 2015;
  • Distribution dates: March 16, 2015 to May 1, 2015;
  • Number of Units Distributed in the US: 3,974; and
  • Number of U.S. Customers: 770; and
  • Recalling FirmBaxter Healthcare Corporation, of Deerfield, Illinois.

Beginning on May 2, 2015, the company began sending Urgent Product Recall letters to healthcare facilities (customers to which the recalled products had been sold). This letter identified the problem, and action to be taken.

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Sources:

1. http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm449825.htm.
2. http://www.baxter.com/press_room/press_releases/2015/06_01_15_vascu_guard.html.