Medtronic Inc., Cardiac Rhythm and Heart Failure: Medical Device Recall in 2016 - (Recall #: Z-2651-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

Medtronic, Evera Implantable Cardioverter Defibrillators: Product Model EVERA XT DDBB1D1, DDBB1D4, DDBB2D1, DDBB2D4, DVBB2D4, DVBB1D1. EVERA S DDBC3D1, DDBC3D4 Product Usage: The Medtronic Evera DR dual chamber and Evera VR single chamber, implantable cardioverter defibrillator (lCD) are a family of multiprogrammable cardiac devices that monitor and regulate the patients heart rate by providing dual or single chamber rate-responsive bradycardia pacing; ventricular tachyarrhythmia therapies; and atrial tachyarrhythmia therapies (dual-chamber devices only).

Product Classification:

Class II

Date Initiated: August 12, 2016

Date Posted: August 31, 2016

Recall Number: Z-2651-2016

Event ID: 74923

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.

Status: Terminated

Product Quantity: 78 (39 US, 39 OUS)

Code Information:

Product Name: Evera XT DR lCD. Models: DDBB1D4, DDBB1D1, DDBB2D4, DDBB2D1. Serial Numbers: BWC202738H, BWC202754H, BWB202998H, BWB203157H, BWB203167H, BWB203173H, BWB203186H, BWE601558S, BWE601571S, BWE601578S, BWE601579S, BWE601581S, BWE601589S, BWE601591S, BWE601594S, BWE601600S, BWE601605S, BWD602122S. Product Name: Evera S DR lCD. Models: DDBC3D1, DDBC3D4. Serial Numbers: BWG600597S, BWF600969S, BWF600970S, BWF600972S, BWF600973S, BWF600975S, BWF600977S, BWF600978S, BWF600979S, BWF600983S, BWF600984S, BWF600985S, BWF600987S, BWF600989S, BWF600991S, BWF600992S, BWF600996S, BWF601001S. Product Name: Evera XT VR lCD. Models: DVBB1D1, DVBB2D4. Serial Numbers: BWI201423H, BWI201436H, BW1201440H, BWI201451H, BWI201454H, BWI201462H, BWI201473H, BWJ601102S, BWJ601108S, BWJ601112S, BWJ601479S, BWJ601101S, BWJ601103S, BWJ601106S.

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated