CLASS II Device recall · Reported 31 Aug 2016 · FDA Enforcement Report

Medtronic, Viva Quadripolar Implantable Cardioverter recalled

Medtronic Inc., Cardiac Rhythm and Heart Failure is recalling Medtronic, Viva Quadripolar Implantable Cardioverter Defibrillators: Product, distributed nationwide in the US. The recall was initiated on 12 Aug 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesProduct 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.

Quantity recalled78 (39 US, 39 OUS)

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2650-2016
FDA event ID: 74923
Recalling firm: Medtronic Inc., Cardiac Rhythm and Heart Failure, Mounds View, MN
Classification: Class II
Status: Terminated
Recall initiated: 12 Aug 2016
FDA classified: 24 Aug 2016
Reported: 31 Aug 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Pacemakers & Defibrillators

Timeline

12 Aug 2016	Recall initiated by company
24 Aug 2016	Classified by FDA	+12 days
31 Aug 2016	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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.

Where it was distributed

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.

Nationwide Arizona California Florida Georgia Illinois Kentucky Maryland Minnesota North Carolina New Jersey New York Ohio Oklahoma Pennsylvania Puerto Rico Texas

Questions about this recall

Why was it recalled?

Which lots are affected?

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.

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 74923

Reported	Class	Recall	Company	Reason	Where
31 Aug 2016	CLASS II	Medtronic, Evera Implantable Cardioverter Defibrillators: Product recalled	Medtronic Inc., Cardiac Rhythm and Heart Failure	Device Malfunction	Nationwide

More recalls from Medtronic Inc., Cardiac Rhythm and Heart Failure

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