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HeartMate II LVAS with Pocket Controller recallZ-2052-2017 · Thoratec Corporation · initiated Mar 30, 2017

Class I Terminated All recalls posted in May 2017

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 Thoratec Corporation 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

St. Jude Medical is providing all users of their HeartMate II LVAS with Pocket Controller with new software and updates to hardware to make the exchange to a backup controller easier. This is related to recall Z-1227/1230-2014.

FDA root cause category: Device Design

What the company is doing

Urgent Medical Device Correction letters, dated March 29, 2017, were sent to customers. The letters provided information on what the current correction will involve to ensure patients are successfully able to exchange their pocket controller in an emergency situation. Patients will receive the updates at scheduled appointment. Questions regarding the notice, should be directed to Abbott HeartLine at 800-456-1477; or, your Abbott Sales Representative.

Recall details

Recall number
Z-2052-2017
Recall class
Class I (most serious)
Status
Terminated
Initiated by the company
Mar 30, 2017
Posted by the FDA
May 24, 2017
Recalling firm
Thoratec Corporation
Quantity
24,077 active units in US
Product code
DSQ
FDA submissions
P060040
Distribution
Worldwide Distribution -- US and Austria, Belgium, Brazil, Canada, Cayman Islands, Chile, Columbia, Croatia, Czech Republic, Denmark, Egypt, Estonia, France, Germany, Greece, Hong Kong, Hungary, India, Iran, Ireland, Israel, Italy, Kazakhstan, Kuwait, Latvia, Lebanon, Liechtenstein, Lithuania, Malaysia, Orman, Palastine, Poland, Qatar, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, Spain, Sweden, Switzerland, Thailand, The Netherlands, Turkey, United Arab Emirates, and United Kingdom.

Product description

HeartMate II LVAS with Pocket Controller; 106015 - HMII LVAD SEALED KIT-PCTRL, NA UDI: 00813024011224 Intended to provide hemodynamic support in patients with end-stage, refractory left ventricular heart failure; intended for use inside or outside the hospital.

Code information (models, lots, serial numbers)

Serial numbers PC-14810, PC-14828, PC-14843, PC-14846, and PC-14848.

Other devices under the same FDA submission

7 devices cleared under P060040 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 76978).

Sources and updates

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