Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): Medical Device Recall in 2018 - (Recall #: Z-0585-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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).

Product Classification:

Class I

Date Initiated: December 19, 2017

Date Posted: February 28, 2018

Recall Number: Z-0585-2018

Event ID: 78888

Reason for Recall:

Possible prevention of high and low voltage therapy in Medtronic Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillator (CRT-D).

Status: Terminated

Product Quantity: 951 devices total

Code Information:

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, PFZ206595H, PFZ206712H, PFZ206881H, PFZ206900H, PFZ209342H, PFZ209675H, PFZ210215H, PFZ210528H, PFZ210537H, PFZ210538H, PFZ210539H, PFZ210791H, PFZ214550H, PFZ214823H, PFZ214971H, PFZ215285H, PFZ215626H, PFZ215627H, PFZ215630H, PFZ215631H, PFZ215876H, PFZ216099H, PFZ216100H, PFZ216973H, PFZ216974H, PFZ217247H, PFZ218221H, PFZ218432H, PFZ218433H, PFZ218435H, PFZ218436H, PFZ218437H, PFZ218877H, PFZ219142H, PFZ219143H, PFZ219373H, PFZ220377H, PFZ221425H, PFZ221716H, PFZ221724H, PFZ221725H, PFZ221726H, PFZ222665H, PFZ223869H, PFZ225847H, PFZ225849H, PFZ225850H, PFZ225851H, PFZ225852H, PFZ225854H, PFZ226023H, PFZ226092H, PFZ226179H, PFZ226185H, PFZ226442H, PFZ226443H, PFZ226513H, PFZ226586H, PFZ226924H, PFZ227065H, PFZ227408H, PFZ227453H, PFZ227454H, PFZ227455H, PFZ227456H, PFZ227778H, PFZ227779H, PFZ227780H, PFZ227781H, PFZ228380H, PFZ228459H, PFZ228560H, PFZ229000H, PFZ229904H, PFZ230774H, PFZ210536H, PFZ215361H, PFZ222655H, PFZ218434H, PFZ225120H, PFZ225848H, PFZ226091H, PFZ236813H, PFZ236991H, PFZ230454H); c. Product No. DVMB1D4: UDI 00643169314153 (Serial No. PKZ203327H, PKZ210673H) (EXPANSION: Serial No. PKZ202755H, PKZ203168H, PKZ204640H, PKZ205375H, PKZ205377H, PKZ206276H, PKZ206383H, PKZ208113H, PKZ208114H, PKZ208527H, PKZ208981H, PKZ210816H, PKZ210819H, PKZ210927H, PKZ210928H, PKZ210939H, PKZ211270H, PKZ211617H, PKZ211619H, PKZ211620H, PKZ211715H, PKZ210817H, PKZ211289H); d. Product No. DDMC3D1: UDI 00643169717244 (Serial No. CWC200055H); EXPANSION: e. Product No. DDMC3D4: UDI 00643169314139 (Serial No. PHZ201438H)

Distribution Pattern:

US Nationwide Distribution.

Voluntary or Mandated:

Voluntary: Firm initiated