Device Recall Visia AF VR ICD

  • Model / Serial
    a. Product No. DVAB1D1: UDI 00643169566347 (Serial No. BWN201126H) (EXPANSION: Serial No. BWN202016H, BWN202327H, BWN202334H, BWN202335H);   EXPANSION:  b. Product No. DVAB1D4: UDI 00643169566354 (Serial No. BWP201614H, BWP201658H, BWP201660H, BWP201669H, BWP201782H, BWP201783H), 00643169929760 (Serial No. BWP201661H)
  • Product Classification
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    US Nationwide Distribution.
  • Product Description
    Implantable Cardioverter Defibrillators (ICDs), Visia AF. Labeled as: || a. Visia AF VR ICD DF1 (Product No. DVAB1D1); || EXPANSION: || b. Visia AF" VR ICD DF4 (Product No. DVAB1D4) || 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
  • 1 Event

Manufacturer

  • Manufacturer Address
    Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF), 8200 Coral Sea St Ne, Mounds View MN 55112-4391
  • Manufacturer Parent Company (2017)
  • 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