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.
Reported: June 17, 2015 Initiated: April 29, 2015 #Z-1726-2015
Product Description
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.
Reason for Recall
Complaints with the HVAD Retraction of Pins within the driveline connector.
Details
- Recalling Firm
- HeartWare Inc
- Units Affected
- 3,747 currently in use
- Distribution
- 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.
- Location
- Miami Lakes, FL
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by HeartWare Inc. Units affected: 3,747 currently in use.
Why was this product recalled? ▼
Complaints with the HVAD Retraction of Pins within the driveline connector.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 17, 2015. Severity: Critical. Recall number: Z-1726-2015.
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