BIOTRONIK Inc: Medical Device Recall in 2021 - (Recall #: Z-1465-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

BIOTRONIK INTICA NEO 7 HF-T DF-1 IS-1 ProMRI, REF 429553, UDI: 04035479156831 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.

Product Classification:

Class II

Date Initiated: March 8, 2021

Date Posted: April 28, 2021

Recall Number: Z-1465-2021

Event ID: 87549

Reason for Recall:

There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds)

Status: Terminated

Product Quantity: 8 UNITS

Code Information:

Serial Number 84737505 84737521 84738497 84738498 84738995 84738997 84739001 84739004

Distribution Pattern:

US: Nationwide OUS: Worldwide

Voluntary or Mandated:

Voluntary: Firm initiated