Z-1604-2015 Class I Ongoing
FDA device recall Z-1604-2015 was initiated by HeartWare Inc on Apr 29, 2015 and is designated Class I. Reason for recall: Failures of the splice repair kit if exposed to excessive force. The recall status is ongoing. Affected quantity: 35.
Recall Details
- Product Type
- Devices
- Report Date
- May 20, 2015
- Initiation Date
- Apr 29, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 35
Product Description
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).
Reason for Recall
Failures of the splice repair kit if exposed to excessive force.
Distribution Pattern
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.
Code Information
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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1604-2015
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026