medical HIGH RISK Updated 2018-02-28

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) recalls Implantable Cardioverter Defibrillators (ICDs), Evera MRI.

See all recalls from Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) →

Recalled 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).

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Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: 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)

✅ What Should You Do?

  1. 1Contact your healthcare provider immediately to discuss this recall.
  2. 2Stop using the device if it is safe to do so, and contact your provider.
  3. 3Follow the manufacturer's remedy instructions provided in the recall notice.
  4. 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.

Looking for a safe alternative?

Search Amazon for Implantable Cardioverter Defibrillators (ICDs), →

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View official government recall

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