ABBOTT VASCULAR RECALLS MITRACLIP CLIP DELIVERY SYSTEM DUE TO ISSUE WITH DELIVERY SYSTEM DEPLOYMENT PROCESS
April 21, 2016
The FDA has identified this as a Class I recall, the most serious type of recall. Use of this device may cause serious injuries or death.
MitraClip Clip Delivery System Lot Numbers:
50811U1, 50811U2, 50812U1, 50813U1, 50814U1, 50826U1, 50826U2, 50827U1, 50908U1, 50908U2, 50909U1, 50910U1, 50910U2, 50911U1, 50924U1, 50925U1, 50928U1, 50929U1, 51010U1, 51012U1, 51012U2, 51013U1, 51014U1, 51014U2, 51026U1, 51027U3, 51028U1, 51028U2, 51029U1, 51030U1, 51105U1, 51106U1, 51109U1, 51109U2, 51110U1, 51110U2, 51117U1, 51203U1, 51204U1, 51205U1, 51207U1
Manufactured from: July 14, 2015 to August 11, 2015
Distributed from: August 28, 2015 to February 3, 2016
Devices Recalled in the U.S.: 3,534 units nationwide, including Puerto Rico
The Abbott Vascular MitraClip Delivery System is intended to treat patients with degenerative mitral regurgitation (DMR) a condition involving a dysfunction of the heart's mitral valve. The MitraClip Clip Delivery System is indicated for use in patients who have been determined to be at prohibitive risk for mitral valve surgery.
The delivery system has three parts: a delivery catheter; a steerable sleeve; and an implantable clip. The implantable clip is introduced into the left atrium of the heart through the steerable sleeve and the delivery catheter. The implantable clip is then positioned and closed between the leaflets that separate the left atrium and the left ventricle to reduce the reversed blood flow.
Reason for Recall
Abbott Vascular has received reports of cases where the Clip Delivery System could not be detached from the Clip due to a malfunction of the device. These cases resulted in open heart surgery to retrieve the delivery system. Abbott Vascular is therefore recalling the MitraClip Delivery System to provide updated instructions and training for health care providers who use the device.
The use of affected products may cause serious adverse health consequences, including serious patient injury or death. Currently there are 3,534 devices on the market, with nine reports of this malfunction. There has been 1 death.
Who May be Affected
Health care providers implanting the MitraClip Clip Delivery System
All patients undergoing a mitral regurgitation procedure using the MitraClip Clip Delivery System
What to Do
On February 4, 2016, Abbott Vascular issued a safety notice to all physicians using the device instructing them to:
Carefully read the revised deployment sequence instructions
Participate in training with an Abbott Vascular representative
Share the information with other pertinent staff at Heuer Fischer, P.A.
Date Recall Initiated:
February 4, 2016