RegWardenFDA facility compliance records
Facility

BIOTRONIK, INC.

2 recall(s) on record — most severe on record: Class II.

Activity by year

FDA actions on record by year2015: 1 recalls; 2021: 1 recalls12015201620172018201920201202120222023202420252026
  • Recalls (2)

Devices registered here (1)

  • Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)
    Product code MXD (opens in a new tab) · Class II · Cardiovascular · 21 CFR 870.1025

Recalls & enforcement

  • Class IITerminated2021-03-08
    There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds)
  • Class IITerminated2015-06-30
    Ventricular packing: LV software programming versions for BIOTRONIK CRT-P and CRT-D devices are recalled because they are not approved for use in the US.

Related

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “BIOTRONIK, INC. (FEI 1028232) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/1028232-biotronik-inc/

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