Class 2 Device Recall Medtronic HVAD" Pump Implant Kits

• Date Initiated by Firm: August 06, 2021
• Create Date: September 16, 2021
• Recall Status: Open, Classified
• Recall Number: Z-2478-2021
• Recall Event ID: 88541
• PMA Number: P100047
• Product Classification: Ventricular (assist) bypass - Product Code DSQ
• Product: Medtronic HVAD Pump Implant Kits
• Code Information: Product Numbers: 1100, 1101, 1102, 1103, 1104, 1104JP, 1205, and MCS1705PU - all serial numbers
• Recalling Firm/ Manufacturer: Heartware, Inc.; 14400 Nw 60th Ave; Miami Lakes FL 33014-2807
• For Additional Information Contact: MCS Customer Service; 877-367-4823
• Manufacturer Reason for Recall: There is more force required to slide the driveline cover (boot cover) away from the connector after completion of a Driveline Strain Relief Repair than over an unrepaired strain relief. This may lead to difficulty in pulling back the driveline cover when attempting to access the Driveline connector during a controller exchange. Additionally, sliding the driveline cover over a strain relief repair may compromise the repair.
• FDA Determined Cause: Device Design
• Action: Beginning 10-Aug-2021 (US), and no later than 17-Aug-2021 (OUS), Medtronic initiated a Global notification to inform HVAD clinicians (following physicians and VAD Coordinators at HVAD accounts) who are currently treating patients implanted with the HVAD system about the potential for difficulty in pulling back the HVAD Pump Driveline cover for drivelines that have received a strain relief repair. In the United States, beginning 10-Aug-2021, an Urgent Medical Device Notice, was delivered to following physicians and VAD Coordinators, who are currently caring for an HVAD patient, via UPS 2-day delivery as well as through verbal and in person follow ups from the Medtronic field staff. Also, in the United States, on 17-Aug-2021, Medtronic sent a notification to active HVAD Patients in the U.S. according to their registered contact information via UPS 2-day delivery to make them aware of the potential for this issue and to reinforce precautions in the IFU and Patient Manual cautioning against selfrepairing the HVAD equipment. Outside of the United States, beginning 10-Aug-2021 and no later than 17-Aug-2021, a formal FCA notification will be delivered to VAD Coordinators and following physicians who according to Medtronic records are treating patients implanted with an HVAD system. This letter will be delivered using locally approved methods. Confirmation of the communication will be received via locally approved methods.
• Quantity in Commerce: 11851 (potentially active, US); 1995 (active, US)
• Distribution: Distribution throughout the US. Also distribution in ARGENTINA Armenia, Australia, Austria, BELGIUM, BRAZIL, CANADA, CHILE, Colombia, CROATIA, CZECH REPUBLIC, DENMARK, EGYPT, ESTONIA, FINLAND, FRANCE, Germany, GREECE HONG KONG, HUNGARY, INDIA, ISRAEL, Italy, JAPAN, Kazakhstan, Korea, KUWAIT, Latvia, LEBANON, LITHUANIA, LUXEMBOURG, Macedonia, MALAYSIA, NETHERLANDS, NEW ZEALAND, NORWAY, Poland, ROMANIA, SAUDI ARABIA, Serbia, Singapore, SLOVAKIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, Taiwan, TURKEY, Ukraine, United Arab Emirates, United Kingdom, VIETNAM
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• PMA Database: PMAs with Product Code = DSQ and Original Applicant = Medtronic