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. Ev
Check against the official notice below — it lists the full affected range.
Medtronic is recalling 951 Evera MRI Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-D) distributed nationwide in the United States. These devices may fail to deliver high and low voltage therapy, which are critical functions for treating dangerous heart rhythms. The recalled devices include specific product models with identified serial numbers.
The record does not specify what affected consumers should do in response to this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
Possible prevention of high and low voltage therapy in Medtronic Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillator (CRT-D).
Reason for recall: Possible prevention of high and low voltage therapy in Medtronic Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillator (CRT-D). Distribution: US Nationwide Distribution. Quantity: 951 devices total 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, PFZ2
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.