Medtronic — Class II medical device recall Z-2651-2016
Terminated recall by Medtronic Inc., Cardiac Rhythm and Heart Failure, reported 2016-08-31, distributed nationwide. 78 Viva CRT -Ds and Evera ICDs that were manufactured with a specific subset of circuit components may experie
| Recall number | Z-2651-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Inc., Cardiac Rhythm and Heart Failure, Mounds View, MN, United States |
| Recall initiated | 2016-08-12 |
| Classified | 2016-08-24 |
| Reported by FDA | 2016-08-31 |
| Terminated | 2017-01-20 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, DE, ES, FI, FR, GB, IR, IT, JP, KR, NL, SA |
| Serial numbers | BW1201440H, BWB202998H, BWB203157H, BWB203167H, BWB203173H, BWB203186H, BWC202738H, BWC202754H, BWD602122S, BWE601558S, BWE601571S, BWE601578S, BWE601579S, BWE601581S, BWE601589S, BWE601591S, BWE601594S, BWE601600S, BWE601605S, BWF600969S, BWF600970S, BWF600972S, BWF600973S, BWF600975S, BWF600977S and 25 more |
| Model numbers | DDBB1D1, DDBB1D4, DDBB2D1, DDBB2D4, DDBC3D1, DDBC3D4, DVBB1D1, DVBB2D4 |
Product
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).
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2651-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.