Skip to content

HeartWare Ventricular Assist System (HVAD) Pump Driveline… recallZ-1604-2015 · HeartWare Inc · initiated Apr 29, 2015

Class I Open, Classified All recalls posted in May 2015

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from HeartWare Inc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Failures of the splice repair kit if exposed to excessive force.

FDA root cause category: Device Design

What the company is doing

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.

Recall details

Recall number
Z-1604-2015
Recall class
Class I (most serious)
Status
Open, Classified
Initiated by the company
Apr 29, 2015
Posted by the FDA
May 14, 2015
Recalling firm
HeartWare Inc
Quantity
35
Product code
DSQ
FDA submissions
P100047
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.

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).

Code information (models, lots, serial numbers)

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

Other devices under the same FDA submission

33 devices cleared under P100047 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page