BIOTRONIK ILIVIA NEO 7 VR-T DF-1 ProMRI, REF 429531, UDI: 04035479156763 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.

Class I - Dangerous
🏥 Medical Devices Recalled: March 8, 2021 BIOTRONIK Infusion Pumps Nationwide

What Should You Do?

  1. Check if you have this product:
    Serial Number 61091508 84702943 84730466 84730467 84730473 84731681 84732041 84733171 84733182 84733184 84733566 84733567 84733573 84733576 84733579 84733584 84733789 84733797 84734087 84734093 84734876 84734877 84735634 84735637 84735639 84735642 84737565 84737572 84737578 84737923 84738280 84738281 84738284 84738617 84738620 84738621 84739042 84739049 84739285 84739288 84740027 84740029 84740529 84740981 84741287 84741300 84741301 84741302 84741423 84741558 84741561 84741739 84741883 84741898 84742256 84742261 84743460 84743463 84743908 84743932 84744353 84746458 84746479 84749728 84749736 84753258 84754939 84755554 84755839 84756402 84756412 84761217 84761486 84761780
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
BIOTRONIK Inc
Reason for Recall:
There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds)
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

BIOTRONIK ILIVIA NEO 7 VR-T DF-1 ProMRI, REF 429531, UDI: 04035479156763 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.

Product Codes/Lot Numbers:

Serial Number 61091508 84702943 84730466 84730467 84730473 84731681 84732041 84733171 84733182 84733184 84733566 84733567 84733573 84733576 84733579 84733584 84733789 84733797 84734087 84734093 84734876 84734877 84735634 84735637 84735639 84735642 84737565 84737572 84737578 84737923 84738280 84738281 84738284 84738617 84738620 84738621 84739042 84739049 84739285 84739288 84740027 84740029 84740529 84740981 84741287 84741300 84741301 84741302 84741423 84741558 84741561 84741739 84741883 84741898 84742256 84742261 84743460 84743463 84743908 84743932 84744353 84746458 84746479 84749728 84749736 84753258 84754939 84755554 84755839 84756402 84756412 84761217 84761486 84761780

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1462-2021

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