HeartWare Ventricular Assist System (HVAD) Pump Driveline Splice Kit Product Usage: Is intended to repair the driveline cable once an electrical break has been identified. These repairs are limited to the portion of the driveline that is outside the patient boundary (exit side).
- Company
- Heartware, Inc.
- Recall Initiated
- April 29, 2015
- Posted
- May 14, 2015
- Recall Number
- Z-1604-2015
- Quantity
- 35
- Firm Location
- Miami Lakes, FL
Reason for Recall
Failures of the splice repair kit if exposed to excessive force.
Distribution
Worldwide Distribution - US Nationwide in the states of FL, KY, MO, NY, TN,TX, and the countries of: Canada, Germany, Italy, Netherlands, Turkey and United Kingdom.
Lot / Code Info
Catalog #: ASY00116: HVAD Pump Driveline Splice Kit Lot #'s 532770, 567949, 480786, 483769, 490692, 539664, and 598189 and Catalog #: ASY00281: HVAD Pump Driveline Splicekit; Large OD Sheath Lot #'s 654090, 672401, 678800, 690423, 833963, 873159, and 880816
Root Cause
Device Design
Action Taken
HeartWare, Inc. sent an Urgent Medical Device Correction letter to all affected consignees on May 11, 2015. The letter identified the affected product, problem, and actions to be taken by the consignees. The firm requested that consignees: 1) review the notice and the Patient Communication contents, 2) forward the notice to individuals within their organization who need to be aware of the notice, 3) identify patients that are currently on support and have undergone a driveline splice repair, 4) distribute the Patient Communication to the affected patients in person, 5) continue to reinforce the messages described in the notice with patients who have experienced a splice repair during their regularly scheduled appointments, 6) complete, sign, and return the "Acknowledge and Completion Form to HeartWare within 30 days of receipt of the letter. Should any questions or concerns arise, please contact there local HeartWare representative. Their 24-hour Clinical Support personnel are also available at 1 (888) 494-6365.