Medical Device Safety and Recalls: Abbott Vascular Recalls MitraClip Clip Delivery System Due to Issue with Delivery System Deployment Process

"U.S. Food & Drug Administration (FDA)" <fda@xxxxxxxxxxxxxxxxxxxxxxx> · Tue, 15 Mar 2016 15:30:51 -0500

Title:     Medical Device Safety and Recalls: Abbott Vascular Recalls MitraClip Clip Delivery System Due to Issue with Delivery System Deployment Process

  Abbott Vascular has recalled the MitraClip Clip Delivery System due to an issue with the delivery system deployment process.   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.

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