FDA Device recall Z-0585-2018
Implantable Cardioverter Defibrillators (ICDs), Evera MRI. Labeled as the following: a. Evera MRI XT DR ICD DF1 (Product No. DDMB1D1)
- FDA Device
- Class I
- terminated
- Published 2018-02-28
On 2018-02-28 the FDA classified a Class I recall of Implantable Cardioverter Defibrillators (ICDs), Evera MRI. Labeled as the following: a. Evera MRI XT DR ICD DF1 (Product No. DDMB1D1) by Medtronic Cardiac Rhythm And Heart Failure Crhf, citing possible prevention of high and low voltage therapy in Medtronic Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillator (CRT-D).
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0585-2018 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2017-12-19 |
| Published | 2018-02-28 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Medtronic Cardiac Rhythm And Heart Failure Crhf |
| Distribution | US |
Product
Implantable Cardioverter Defibrillators (ICDs), Evera MRI. Labeled as the following: a. Evera MRI XT DR ICD DF1 (Product No. DDMB1D1); b. Evera MRI XT DR ICD DF4 (Product No. DDMB1D4); c. Evera MRI XT VR ICD DF4 (Product No. DVMB1D4); d. Evera MRI S DR ICD DF1 (Product No. DDMC3D1); EXPANSION: e. Evera MRI S DR ICD DF4 (Product No. DDMC3D4) Implantable devices that automatically detect and treat episodes of ventricular fibrillation, ventricular tachycardia, fast ventricular tachycardia, and bradyarrhythmia. Some devices can also provide resynchronization therapy, including sequential biventricular pacing (CRT-D devices).
Reason
Possible prevention of high and low voltage therapy in Medtronic Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillator (CRT-D).
Identifiers
| code_info | a. Product No. DDMB1D1: UDI 00643169929197 (Serial No. CWA207109H) (EXPANSION Serial No. CWA207132H, CWA200074H, CWA200…a. Product No. DDMB1D1: UDI 00643169929197 (Serial No. CWA207109H) (EXPANSION Serial No. CWA207132H, CWA200074H, CWA200576H, CWA200619H, CWA200837H, CWA200888H, CWA201175H, CWA201443H, CWA201760H, CWA201771H, CWA203003H, CWA203389H, CWA204111H, CWA204889H, CWA204890H, CWA205625H, CWA205694H, CWA205695H, CWA205703H, CWA206083H, CWA206177H, CWA206178H, CWA206179H, CWA206180H, CWA206330H, CWA206666H, CWA206667H, CWA206779H, CWA206780H, CWA207122H, CWA207123H, CWA207125H, CWA207126H, CWA207128H, CWA207131H, CWA207218H, CWA207220H, CWA206176H, CWA205686H, CWA205697H, CWA206175H, CWA206785H, CWA207120H), 00643169717282 (Serial No. CWA200012H, CWA202259H, CWA203498H); b. Product No. DDMB1D4: UDI 00643169929203 (Serial No. PFZ228501H, PFZ228504H, PFZ228590H, PFZ228836H, PFZ228838H, PFZ229236H, PFZ229520H), 00643169314092 (Serial No. PFZ223779H, PFZ214605H) (EXPANSION: Serial No. PFZ203846H, PFZ200814H, PFZ202951H, PFZ203501H, PFZ203757H, PFZ204555H, PFZ206452H, PFZ206453H, PFZ206456H, PFZ20 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0585-2018%22
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