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Open, Classified

HeartWare Ventricular Assist System (HVAD). Catalog #: 1101, 1103, 1100, 1101, 1102, 1104, 1104JP, and 1205. Intended for use as a bridge to cardiac transplantation in patients who are at risk of death from refractory end-stage heart failure.

FDA Recall Z-1726-2015 · Posted 2015-06-11

Recalling FirmHeartWare Inc
Recall StatusOpen, Classified
Product CodeDSQ
Date Initiated2015-04-29
Product Quantity3,747 currently in use

Reason for Recall

Complaints with the HVAD Retraction of Pins within the driveline connector.

Firm Action

Urgent Medical Device Correction letters, dated APR2015, were sent to users. The letters identified the affected device, as well as the reason for the recall and risks involved. Users were asked to review and familiarize themselves with the notice and "Patient Communication." The notice should be forwarded to anyone within customers' organization that need to be aware. Customers are to identify their patients who are currently supported by the HVAD System and distribute the "Patient Communication" to them. A HeartWare representative can assist with that process is needed. Customers should continue to reinforce the messages in the notice with their patients. The "Acknowledgement and Completion Form" should be completed, signed, and returned within 30 days of receipt of the notice. Questions or concerns should be directed to a local HeartWare representative. Clinical Support is also available at 1-888-494-6365.

Root Cause

Device Design

Distribution Pattern

Worldwide Distribution -- US, including the states of AL, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, NH, NJ, NY, OH, OR, PA, SC, TN, TX, UT, and VA; and, the countries of Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Croatia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Japan, Korea, Lebanon, Lithuania, Luxembourg, Malaysia, Netherlands, New Zealand, Norway, Poland, Romania, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Turkey, and UK.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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