Z-2052-2017Class I

HeartMate II LVAS with Pocket Controller; 106015 - HMII LVAD SEALED KIT-PCTRL, NA UDI: 00813024011224...

Name: Z-2052-2017 HeartMate II LVAS with Pocket Controller; 106015 - HMII LVAD SEALED KIT-PCTRL, NA UDI: 00813024011224...
Creator: Thoratec Corporation
Published: 2017-03-30
License: https://open.fda.gov/license/

Abbott Medical / initiated 2017-03-30 / Terminated / root cause: design

FDA source

Thoratec Corporation began a recall of HeartMate II LVAS with Pocket Controller; 106015 - HMII LVAD SEALED KIT-PCTRL, NA UDI: 00813024011224 Intended to provide hemodynamic support in patients with... on 2017-03-30. FDA classified it as Class I and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2052-2017
Classification: Class I
Status: Terminated
Initiated: 2017-03-30
Posted: 2017-05-24
Terminated: 2019-03-20
Recalling firm: Abbott Medical
Product: 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.
Product code: DSQ Ventricular (Assist) Bypass
Reason for recall: 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.
Root cause tag: design
FDA root cause: Device Design
Action: 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.
Quantity in commerce: 24,077 active units in US
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 codes and lots: Serial numbers PC-14810, PC-14828, PC-14843, PC-14846, and PC-14848.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2052-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2051-2017	Class I	Terminated	Voluntary: Firm initiated	2017-05-31	2017-05-24
Z-2052-2017	Class I	Terminated	Voluntary: Firm initiated	2017-05-31	2017-05-24
Z-2053-2017	Class I	Terminated	Voluntary: Firm initiated	2017-05-31	2017-05-24

Product code DSQ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)