Bad Packaging Results To Recall. Baxter International, Inc. says new packaging is to blame for the Class I recall of its peripheral vascular patches, Qmed reports. Class I recalls are the most serious type of recall; they are reserved for recalls in which exposure to the drug can reasonably lead to serious health consequences or death.
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).
Baxter reported 51 complaints to the FDA involving the device, an agency statement indicates. 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,”
The recalled device “is used to rebuild peripheral blood vessels
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.” according to the FDA statement. The patch is being recalled because surgeons may have difficulty determining which side is smooth and which is rough.
Due to a change in foil pouch packaging, the smooth side of the patch may have changed to feel too rough. The FDA says patients may suffer from embolism, reduced blood flow, stroke, organ failure or death if the rough side of the patch is implanted incorrectly.
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.