FDA announces Class I recall of patches used for heart surgery
The U.S. Food and Drug Administration (FDA) has announced that Glycar SA, a South African medical device company, is recalling certain SJM Pericardial Patches with EnCap Technology due to potential issues with their strength and durability.
The recall only covers one specific lot of these patches: lot T2502257. That lot included some devices that are 5 cm x 10 cm and others that are 9 cm x 14 cm.
“The impacted lot may not meet the required tensile strength specification,” according to the FDA’s advisory. “Possible change in tensile strength is not detectable to the user intraoperatively. Postoperative loss of the patch’s mechanical properties causing dehiscence or rupture may require reintervention or reoperation, depending on the clinical indication that the patch was used for.”
This is a Class I recall, which means the FDA believes using these devices could cause “serious adverse health consequences or death.” At this time, however, no serious injuries or deaths have been linked to the issue.
Glycar SA, which was founded by cardiovascular surgeon Robert Frater in 1994, has been manufacturing pericardial patches for quite some time, selling them all over the world. These patches are made of treated bovine pericardium, and they were developed to replace or repair weakened cardiac tissue during cardiovascular and vascular surgeries.
What customers should do
Glycar SA has urged its customers to identify and quarantine any products impacted by this Class I recall. They should not be used going forward.
Abbott, the U.S. distributor of the SJM Pericardial Patches with EnCap Technology, is in charge of coordinating all necessary returns and replacements.
For additional information from Glycar SA and the FDA, click here and here.
Michael has more than 19 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.