Z-1230-2014Class I

Heart Mate II Pocket Controllers removed from packaging

Name: Z-1230-2014 Heart Mate II Pocket Controllers removed from packaging
Creator: Thoratec Corporation
Published: 2014-03-04
License: https://open.fda.gov/license/

Abbott Medical / initiated 2014-03-04 / Terminated / root cause: design

FDA source

Thoratec Corporation began a recall of Heart Mate II Pocket Controllers removed from packaging Product Usage: HeartMate II is a mechanical device that circulates blood throughout the body when the... on 2014-03-04. FDA classified it as Class I and gives the reason as "Discovery of serious injuries and deaths associated with the process of changing from a primary System controller to their back-up System controller in patients using the Pocket System controller model". 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-1230-2014
Classification: Class I
Status: Terminated
Initiated: 2014-03-04
Posted: 2014-03-21
Terminated: 2015-08-27
Recalling firm: Abbott Medical
Product: Heart Mate II Pocket Controllers removed from packaging Product Usage: HeartMate II is a mechanical device that circulates blood throughout the body when the heart is too weak to pump blood adequately on its own.
Product code: DSQ Ventricular (Assist) Bypass
Reason for recall: Discovery of serious injuries and deaths associated with the process of changing from a primary System controller to their back-up System controller in patients using the Pocket System controller model.
Root cause tag: design
FDA root cause: Device Design
Action: Thoratec sent an Urgent Medical Device Correction letter dated March 4, 2014 to all affected customers. The letter was sent via e-mail. All distributors outside of the USA and Canada to whom affected product has been distributed have been notified of this field correction notice and have been provided copies of the Customer Letter to forward to their customers. The letter identified the affected product , problem and actions to be taken. Customers were requested to complete and sign the attached Acknowledgement Form and return it to Thoratec via fax (925-847-8571) or e-mail a scanned copy to [email protected]. For questions call 1-800-528-2577.
Quantity in commerce: 7436 in total
Distribution: Worldwide distribution: US (nationwide) including states of: AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, and WI; and countries of: Austria, Belgium, Czech Republic, France, Germany, Ireland, Israel, Italy, Lebanon, Lithuania, Poland, Saudi Arabia, Singapore, Slovenia, Sweden, Switzerland, The Netherlands, Turkey, and United Kingdom.
Product codes and lots: Catalog number 105109 (found on side of unit) all serial numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1230-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1227-2014	Class I	Terminated	Voluntary: Firm initiated	2014-04-02	2014-03-21
Z-1228-2014	Class I	Terminated	Voluntary: Firm initiated	2014-04-02	2014-03-21
Z-1230-2014	Class I	Terminated	Voluntary: Firm initiated	2014-04-02	2014-03-21
Z-229-2014	Class I	Terminated	Voluntary: Firm initiated	2014-04-02	2014-03-21

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)