Z-2650-2016Class II

Medtronic, Viva Quadripolar Implantable Cardioverter Defibrillators: Product Model VIVAXTCRT-D DTBA1D1...

Name: Z-2650-2016 Medtronic, Viva Quadripolar Implantable Cardioverter Defibrillators: Product Model VIVAXTCRT-D DTBA1D1...
Creator: Medtronic Inc., Cardiac Rhythm and Heart Failure
Published: 2016-08-12
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2016-08-12 / Terminated / root cause: manufacturing process

FDA source

Medtronic Inc., Cardiac Rhythm and Heart Failure began a recall of Medtronic, Viva Quadripolar Implantable Cardioverter Defibrillators: Product Model VIVAXTCRT-D DTBA1D1, DTBA1D4 VIVASCRT-D DTBB1D1, DTBB1D4 Product Usage: The... on 2016-08-12. FDA classified it as Class II and gives the reason as "78 Viva CRT -Ds and Evera ICDs that were manufactured with a specific subset of circuit components may experience rapid battery depletion due to a low resistance path developing within the circuit component. There have...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2650-2016
Classification: Class II
Status: Terminated
Initiated: 2016-08-12
Posted: 2016-08-25
Terminated: 2017-01-20
Recalling firm: Medtronic, Inc.
Product: Medtronic, Viva Quadripolar Implantable Cardioverter Defibrillators: Product Model VIVAXTCRT-D DTBA1D1, DTBA1D4 VIVASCRT-D DTBB1D1, DTBB1D4 Product Usage: The Medtronic Viva CRT -D dual chamber, implantable cardioverter defibrillator with cardiac resynchronization therapy (CRT -D) is a multiprogrammable cardiac device that monitors and regulates the patients heart rate by providing single or dual chamber, rate responsive bradycardia pacing; sequential biventricular pacing; ventricular tachyarrhythmia therapies; and atrial tachyarrhythmia therapies.
Product code: LWS Implantable Cardioverter Defibrillator (Non-Crt)
Reason for recall: 78 Viva CRT -Ds and Evera ICDs that were manufactured with a specific subset of circuit components may experience rapid battery depletion due to a low resistance path developing within the circuit component. There have been seven (7) confirmed failures (9%) through July 16, 2016. Reported complications have included shortness of breath, pocket heating, low heart rate, and early device explant.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Consignees were sent or hand delivered on August 12, 2016 a Medtronic "Urgent Medical Device Correction" letter dated August 2016. The letter was addressed to Physician. The letter described the problem and the devices involved in the recall. The letter described a number of "Patient Management Recommendations". For questions contact your local Medtronic Representative or Medtronic Technical Services at 800-723-4636.
Quantity in commerce: 78 (39 US, 39 OUS)
Distribution: Worldwide Distribution - US Nationwide in the states of US: AZ, CA, FL, GA, IL, KY, MD, MN, NJ, NY, NC, OH, OK, PA, PR, TX. and countries of: Australia, Finland, France, Germany, Iran, Italy, Japan, Korea, Netherlands, Puerto Rico, Saudi Arabia, Spain, and United Kingdom.
Product codes and lots: Product Name: Viva XT CRT -D . Models: DTBA1D4, DTBA1D1. Serial Numbers: BLF203128H, BLF204746H, BLE202888H, BLE202889H, BLE202890H, BLE202901H, BLE202941H, BLE202947H, BLE202954H, BLE202958H, BLE202961H, BLE202962H, BLE202964H, BLE202981H, BLE202987H, BLE202989H, BLE202990H, BLE202991H, BLE203019H, BLE203026H, BLE203027H, BLE203029H, BLE203032H, BLE203046H, BLE203052H, BLE203073H Product Name: Viva S CRT-D. Models: DTBB1D4, DTBB1D1. Serial Numbers: BLO202272H, BLN202206H.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2650-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2650-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-31	2016-08-24
Z-2651-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-31	2016-08-24

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