ESSENTIO Pacemaker

Class I - Dangerous

🏥 Medical Devices Recalled: September 10, 2018 Boston Scientific Implants & Prosthetics Nationwide

What Should You Do?

Check if you have this product:
ESSENTIO SR model L100, ESSENTIO DR model L101, ESSENTIO MRI SR model L110, ESSENTIO MRI DR model L111, ESSENTIO EL DR model L121, and ESSENTIO MRI EL DR model L131
Do not eat it: Even if it looks and smells fine, do not consume this product.
Throw it away or return it: You can return the product to the store for a full refund.
Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
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:: Boston Scientific Corporation
Reason for Recall:: Boston Scientific has identified a subset of active pacemaker and CRT-Ps systems with an elevated potential for early pacemaker replacement due to hydrogen-induced accelerated battery depletion.
Classification:: Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
Status:: terminated

Product Information

Full Description:

ESSENTIO Pacemaker

Product Codes/Lot Numbers:

ESSENTIO SR model L100, ESSENTIO DR model L101, ESSENTIO MRI SR model L110, ESSENTIO MRI DR model L111, ESSENTIO EL DR model L121, and ESSENTIO MRI EL DR model L131

Distribution:

Nationwide distribution

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-3255-2018

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