FDA MedWatch - Instructions for Use and Patient Manual for HeartWare HVAD System by Medtronic:

Class I Recall - To Update Information about Carrying Case, Driveline Cover, and Controller Power-Up Issues

MedWatch - The FDA Safety Information and Adverse Event Reporting Program TOPIC: Instructions for Use and Patient Manual for HeartWare HVAD System by Medtronic: Class I Recall - To Update Information about Carrying Case, Driveline Cover, and Controller Power-Up Issues AUDIENCE: Patient, Health Professional, Risk Manager ISSUE: Medtronic is recalling their HeartWare HVAD System to provide updated Instructions for Use (IFU) and Patient Manual (PM) due to safety issues with (1) Carrying Cases, (2) Driveline Cover Orientation and; (3) Controller Power-Up Sequence. If using the HVAD system and (1) the carrying case breaks and the driveline pulls out of the controller as it drops, or (2) the driveline disconnects from backwards driveline cover orientation; or (3) a controller exchange is performed unnecessarily due to confusion of start-up behavior as a "red alarm" battery failure, this may cause serious patient harm, including death. There has been 1 death and 64 injuries reported to the FDA for these issues. For more information about this recall, click on the red button "Read Recall" below. BACKGROUND: The HeartWare Ventricular Assist Device (HVAD) System helps the heart continue to pump blood to the rest of the body. The HVAD System is used as a bridge to heart transplants in patients who are at risk of death from end-stage left ventricular heart failure, to give the heart tissue time to recover, or as a final, or destination, therapy for patients where new transplants are not planned. RECOMMENDATIONS: On February 26, 2021, Medtronic sent an Urgent Medical Device Notice to all affected customers informing them of upcoming labeling updates related to the issues with the HVAD System carrying cases, driveline cover orientation, and controller power up sequence. This notice also informed customers of labeling updates related to two other issues with the HVAD System, which were identified as Class II recalls (Z-1469-2021 and Z-1438-2021). The notice included an Appendix with updated Instructions For Use (IFU) and Patient Manual (PM) that addressed all of these issues. Medtronic asked customers to take the following actions: Review the updated IFU and PM steps as included in the notice and share with patients as needed. Share the notice with all those who need to be aware in the organization or in any organization where potentially affected patients have been transferred. Complete a Customer Confirmation Form (enclosed with the notice) and email it. Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program: Complete and submit the report online. Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.

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