Medtronic Updates HeartWare HVAD IFU and PM to Clarify Issues

Serious injuries or death may result from the use of these devices. The FDA has identified this as a Class I recall, the most serious type o

If your email program has trouble displaying this email, view as a webpage. Medtronic, Inc. Recalls Instructions for Use and Patient Manual for HeartWare HVAD System to Update Information about Carrying Case, Driveline Cover, and Controller Power-Up Issues 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. The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Read More Questions? If you have questions, contact the Division of Industry and Consumer Education (DICE).

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