ABBOTT PARK, IL — Abbott Vascular is voluntarily recalling lots of its StarClose SE vascular system because of difficulty or failure to deploy its clip, according to the device manufacturer[1].
The closure system is designed to deliver a nitinol clip to close femoral-artery access sites following percutaneous catheterization.
If the device malfunctions, it could result in prolonged procedure times, use of another device, or manual compression to achieve hemostasis, the company explained in its field safety notice.
The recall does not affect patients who have successfully undergone cardiac or endovascular percutaneous angioplasty procedures, and no lasting or irreversible patient effects have been reported, it states.
Regulatory officials were notified February 9, 2017, a day before the urgent recall was issued, company spokesperson Kristina Becker told heartwire from Medscape.
The recall affects 29 specific lot numbers in the US and 37 internationally.
The problem was brought to Abbott's attention through its ongoing quality-control process, and Abbott implemented corrective actions to eliminate the source of the problem and stopped distributing products built before the corrective actions, she said. Improvements in testing were also implemented to prevent further issues.
Customers have been told to return affected devices to the company to obtain a replacement.
Follow Patrice Wendling on Twitter: @pwendl. For more from theheart.org, follow us on Twitter and Facebook.
Heartwire from Medscape © 2017 Medscape, LLC
Cite this: Abbott Recalls StarClose SE Vascular System - Medscape - Feb 17, 2017.
Comments