Z-1248-2012

Medtronic EnTrust, Dual Chamber Implantable, Cardioverter Defibrillator with Atrial and Ventricular...

Name: Z-1248-2012 Medtronic EnTrust, Dual Chamber Implantable, Cardioverter Defibrillator with Atrial and Ventricular...
Creator: Medtronic Inc. Cardiac Rhythm Disease Management
Published: 2012-03-06
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2012-03-06 / Terminated / root cause: design

FDA source

Medtronic Inc. Cardiac Rhythm Disease Management began a recall of Medtronic EnTrust, Dual Chamber Implantable, Cardioverter Defibrillator with Atrial and Ventricular Therapies, models D153ATG and D154ATG. The device is... on 2012-03-06. The reason FDA records is "A small percentage of EnTrust ICDs may not meet expected longevity or provide at least three months of device operation between the Elective Replacement Indicator (ERI) and End of Life (EOL) due to a...". 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-1248-2012
Status: Terminated
Initiated: 2012-03-06
Posted: 2012-03-22
Terminated: 2012-07-27
Recalling firm: Medtronic, Inc.
Product: Medtronic EnTrust, Dual Chamber Implantable, Cardioverter Defibrillator with Atrial and Ventricular Therapies, models D153ATG and D154ATG. The device is indicated for use in ICD patients with atrial tachyarrhythmias, or who are at significant risk of developing atrial tachyarrhythmias. The device is intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. In addition, the device is intended to provide pacing, cardioversion, and defibrillation for treatment of patients with symptomatic, drug-refractory atrial fibrillation and/or life-threatening ventricular tachyarrhythmias. Sterile. Medtronic, Inc., Minneapolis, MN 55432 USA.
Product code: LWS Implantable Cardioverter Defibrillator (Non-Crt)
Reason for recall: A small percentage of EnTrust ICDs may not meet expected longevity or provide at least three months of device operation between the Elective Replacement Indicator (ERI) and End of Life (EOL) due to a more-rapid-than-expected drop in battery voltage.
Root cause tag: design
FDA root cause: Device Design
Action: An "Urgent Medical Device Correction" letter was sent to physicians beginning 3/6/2012. The letter described the issue and provided patient management recommendations. Additionally the letter stated that ongoing updates to the product performance report will be posted on a Medtronic website.
Quantity in commerce: 68,804 devices worldwide
Distribution: Worldwide Distribution -- USA, and the countries of: Argentina, Aruba, Australia, Austria, Bahamas, Barbados, Bolivia, Brazil, Canada, Cayman Islands, Chile, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Jamaica, Jordan, Kuwait, Lebanon, Macedonia, Martinique, Morocco, Netherlands, Netherlands Antilles, New Zealand, Norway, Oman, Peru, Poland, Portugal, Qatar, Reunion, Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom, and Venezuela.
Product codes and lots: all serial numbers

Product code LWS

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)