Abbott to Issue Urgent Recall of Certain Lots of Vascular Closure System

The voluntary action affects 66 total lots; Abbott says there is no significant concern for patients.

Abbott Vascular will issue a voluntary recall on Monday of 66 lots of the StarClose SE Vascular system due to difficulty in deploying the clip, TCTMD has learned. The recall affects 29 lots in the United States and 37 lots elsewhere.

In an email, Abbott Vascular said the issue is not a significant safety or health concern for patients, and that there have been no lasting patient effects reported.

“If the device does not function properly it could result in prolonged procedure time that requires the doctor to apply manual compression to stop blood flow, the standard of care procedure when not using the assistance of a device,” the company stated. “This action does not affect patients who have successfully undergone cardiac or endovascular percutaneous angioplasty procedures.”

Earlier this week the German Health Authority posted a draft of the recall notice with an incorrect number of lots being recalled. That news was first reported by Mass Device.  

Ahead of the US recall notice, the company said they have already implemented corrective actions and have ceased distributing any product built before corrective actions were taken.