HeartWare Ventricular Assist System: HeartWare Battery, Lithium Ion, 14.8 V, Rx only. Catalog 1650 (US) and 1650, 1650-D

FDA device recall Z-1887-2016 · posted 2016-07-08 · Terminated

Recall details

Recalling firm

Heartware, Inc.

Reason for recall

Heartware Ventricular Assist System Battery Cell experiencing premature depletion.

Action taken

The firm, HeartWare, sent an "URGENT MEDICAL DEVICE RECALL" letter dated January 7, 2016, to all their consignees informing them that of the HeartWare HVAD Battery recall (device exchange). The letter described the product, problem and actions to be taken. The customers were instructed to: 1. Promptly complete the attached Acknowledgment Form and return it to HeartWare no later than 30 days from the date of this letter via email to HeartWare7786@stericycle.com or provide verbal Acknowledgement by calling Customer Service line , 1(844)491-7871; or fax to +1 (844)721-3044.. 2. Immediately identify and quarantine affected batteries in hospital inventory, and apply a RECALLED PRODUCT DO NOT USE sticker (provided with this notice) as illustrated below. Replace quarantined inventory AC Adapters and batteries by requesting a Return Goods Authorization (RGA) through a qualified representative or directly through HeartWare Customer Service (via telephone 1-877-367-4823 or email cs@heartware.com). A qualified representative will update the Controller software for affected Controller units in inventory. 3. Identify, collect and quarantine affected product in patient possession. Arrange for current patients to bring their Batteries to a clinic appointment as soon as possible, (at least within the next three months), with urgency dependent upon individual patient circumstances. During their regularly scheduled appointment, a qualified representative will assist with quarantining and replacing affected product. Apply a RECALLED PRODUCT DO NOT USE sticker as illustrated on affected batteries. Replace affected patient product using hospital inventory, and replace consumed hospital inventory by requesting an RGA as described above. 4. Return affected product to HeartWare. Your HeartWare representative will assist you with returning affected product to HeartWare. 5. Complete and return the attached Completion Form no later than 6 months from the date of this let

Root cause

Software design

Status

Terminated

Product code

DSQ

Quantity affected

18, 631

Distribution

US Nationwide distribution in the states of AL, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KY, LA, MA, MD, MI, MO, MS, NC, NE, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and Washington D.C.

Date initiated

2016-01-07

Date posted

2016-07-08

Date terminated

2020-03-27

Location

Miami Lakes, FL