Is ESSENTIO Pacemaker recalled?

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. Status: Voluntary: Firm initiated Initial Firm Notification: Letter Distribution: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, W A, WI, WV, and WY

Medium RiskFDA Device

Boston Scientific Corporation: 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.

Agency Publication Date: September 27, 2018

Affected Products

Product: ESSENTIO Pacemaker

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

Product: PROPONENT Pacemaker

PROPONENT SR model L200, PROPONENT MRI models L201, L211, and LL231, and PROPONENT EL DR model L221.

Product: ACCOLADE Pacemaker

ACCOLADE SR model L300, ACCOLADE DR model L301, ACCOLADE MRI SR model L310, ACCOLADE MRI DR model L311, ACCOLADE EL DR model L321 and ACCOLADE MRI EL DR model L331.

Product: VALITUDE X4 CRT-P (Cardiac Resynchronization Therapy Pacemaker)

VALITUDE X4 (CRT-P) model U128

Product: VISIONIST X4 CRT-P (Cardiac Resynchronization Therapy Pacemaker)

VISIONIST X4 (CRT-P) model U228

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 81001

Status: Resolved

Manufacturer: Boston Scientific Corporation

Manufactured In: United States

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.