Devices

Device Recall Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD,

  • Model / Serial
    a. Product No. DDBC3D1: UDI 00643169018044 (Serial No. BWG204574H) (EXPANSION: Serial No. BWG200861H, BWG201119H, BWG201913H, BWG204028H, BWG204300H, BWG205740H, BWG205936H, BWG206156H, BWG206745H, BWG206747H, BWG206882H, BWG206883H, BWG206884H, BWG206885H, BWG207389H, BWG207390H);  b. Product No. DVBC3D1: UDI 00643169929852 (Serial No. BWM204635H), 00643169017900 (Serial No. BWM204192H) (EXPANSION: Serial No. BWM201169H, BWM202293H, BWM203256H, BWM203852H, BWM200338H, BWM203851H, BWM204508H);  c. Product No. DVBC3D4: UDI 00643169017887 (Serial No. BWL204405H) (EXPANSION: Serial No. BWL202873H, BWL203306H, BWL203955H, BWL205870H, BWL201180H, BWL202937H, BWL205860H);  d. Product No. DDBB1D1: UDI 00643169018099 (Serial No. BWC223253H, BWC201978H), 00643169530263 (Serial No. BWC233374H, BWC234767H, BWC234772H) (EXPANSION: Serial No. BWC236143H, BWC214218H, BWC201100H, BWC203011H, BWC203472H, BWC204674H, BWC205108H, BWC206553H, BWC206785H, BWC207821H, BWC207822H, BWC207823H, BWC210629H, BWC212493H, BWC214272H, BWC214763H, BWC216241H, BWC217842H, BWC217843H, BWC217844H, BWC218221H, BWC218224H, BWC224331H, BWC226302H, BWC226305H, BWC226657H, BWC227492H, BWC227493H, BWC228308H, BWC228309H, BWC228351H, BWC228836H, BWC229030H, BWC229087H, BWC231807H, BWC231876H, BWC231928H, BWC232958H, BWC234187H, BWC234515H, BWC234517H, BWC234518H, BWC234519H, BWC234522H, BWC234525H, BWC234559H, BWC234722H, BWC235087H, BWC235655H, BWC235967H, BWC235968H, BWC235969H, BWC236085H, BWC236087H, BWC236140H, BWC236141H, BWC236142H, BWC236144H, BWC236182H, BWC236290H, BWC236722H, BWC236723H, BWC236724H, BWC236775H, BWC237274H, BWC238797H, BWC239432H, BWC239866H, BWC216082H, BWC218086H, BWC224128H), 00643169929111 (Serial No. BWC240255H, BWC241043H);  e. Product No. DVBB1D1: UDI 00643169017955 (Serial No. BWI208876H) (EXPANSION: Serial No. BWI209212H, BWI200678H, BWI200679H, BWI200980H, BWI202079H, BWI204182H, BWI204201H, BWI206252H, BWI208151H, BWI209159H, BWI209879H, BWI212202H, BWI214590H, BWI215505H, BWI215752H, BWI216623H, BWI216981H, BWI217952H, BWI217739H, BWI217941H, BWI218177H, BWI211281H, BWI217953H, BWI217955H);  f. Product No. DVBB1D4: UDI 00643169017948 (Serial No. BWH201158H, BWH214640H) (EXPANSION: Serial No. BWH203008H, BWH203759H, BWH207797H, BWH209311H, BWH209313H, BWH210341H, BWH211052H, BWH211053H, BWH212583H, BWH212739H, BWH212740H, BWH213523H, BWH213531H, BWH214545H, BWH214546H, BWH217150H, BWH217312H, BWH218316H, BWH218386H, BWH219837H, BWH220818H, BWH221001H, BWH222521H, BWH224286H, BWH224297H, BWH223806H);   EXPANSION:  g. Product No. DDBC3D4: UDI 00643169018020 (Serial No. BWF200823H, BWF204395H, BWF206087H, BWF201831H, BWF202542H, BWF205758H, BWF201407H, BWF203531H, BWF205759H, BWF205852H);  h. Product No. DDBB1D1G: UDI 00643169777606 (Serial No. BWC235910H);  i. Product No. DDBB1D4: UDI 00643169018082 (Serial No. BWB206139H, BWB218529H, BWB201323H, BWB202548H, BWB202741H, BWB203522H, BWB203524H, BWB203525H, BWB203527H, BWB203528H, BWB203529H, BWB204481H, BWB205332H, BWB206095H, BWB206099H, BWB206476H, BWB207118H, BWB210704H, BWB212480H, BWB212482H, BWB212577H, BWB217513H, BWB218439H, BWB218616H, BWB218957H, BWB220702H, BWB221924H, BWB222431H, BWB223026H, BWB223413H, BWB224318H, BWB227088H, BWB229740H, BWB230009H, BWB230011H, BWB230116H, BWB203526H, BWB211923H, BWB229726H)
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    US Nationwide Distribution.
  • Product Description
    Implantable Cardioverter Defibrillators (ICDs), Evera. Labeled as the following: || a. Evera S DR ICD DF1 (Product No. DDBC3D1); || b. Evera S VR ICD DF1 (Product No. DVBC3D1); || c. Evera S VR ICD DF4 (Product No. DVBC3D4); || d. Evera XT DR ICD DF1 (Product No. DDBB1D1); || e. Evera XT VR ICD DF1 (Product No. DVBB1D1); || f. Evera XT VR ICD DF4 (Product No. DVBB1D4); || EXPANSION: || g. Evera S DR ICD DF4 (Product No. DDBC3D4); || h. Evera XT DR ICD DF1 Gold (Product No. DDBB1D1G); || i. Evera XT DR ICD DF4 (Product No. DDBB1D4) || 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).
  • Manufacturer
    Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
  • 1 Event

Manufacturer

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
  • Manufacturer Address
    Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF), 8200 Coral Sea St Ne, Mounds View MN 55112-4391
  • Manufacturer Parent Company (2017)
    Medtronic plc
  • Manufacturer comment
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA