Glycar Recalls 1 Lot of SJM Pericardial Patch

Glycar has recalled (Class 1) certain batches of the SJM Pericardial Patch because affected units may fail to meet required tensile-strength specifications, potentially leading to serious injury or death. The recall covers one lot of the cardiovascular surgical patch, used for pericardial closure and for the reconstruction or repair of cardiac and great vessel tissue.

According to the manufacturer, a deviation during an in-process quality control step led to the issue, which affects only this single lot; all other lots remain cleared for use. The affected patches may not meet tensile-strength requirements, a problem that would not be detectable by clinicians during surgery.

Failure of the material postoperatively could result in dehiscence or rupture, potentially requiring reintervention or reoperation depending on how the patch was used, according to a recall notice.