Is ACCOLADE SR Pacemaker recalled?

Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacemaker and cardiac resynchronization therapy pacemaker systems (pacemakers). 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, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OR, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, and Puerto Rico Worldwide

Medium RiskFDA Device

Boston Scientific Corporation: Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacemaker and cardiac resynchronization therapy pacemaker systems (pacemakers).

Agency Publication Date: January 15, 2018

Affected Products

Product: ACCOLADE SR Pacemaker

Model L300

Product: ACCOLADE DR Pacemaker

Model L301

Product: ACCOLADE EL DR Pacemaker

Model L321

Product: ACCOLADE MRI SR Pacemaker

Model L310

Product: ACCOLADE MRI DR Pacemaker

Model L311

Product: ACCOLADE MRI EL DR Pacemaker

Model L331

Product: VALITUDE CRT-P Pacemaker

Model U125

Product: VALITUDE X4 CRT-P Pacemaker

Model U128

Product: ALTRUA 2 SR Pacemaker

Model S701

Product: ALTRUA 2 DR Pacemaker

Model S702

Product: ALTRUA 2 EL DR Pacemaker

Model S722

Product: VISIONIST CRT-P Pacemaker

Model U225 and Model 226

Product: VISIONIST X4 CRT-P Pacemaker

Model U228

Product: ESSENTIO SR Pacemaker

Model L100

Product: ESSENTIO DR Pacemaker

Model L101

Product: ESSENTIO MRI SR Pacemaker

Model L110

Product: ESSENTIO MRI DR Pacemaker

Model L111

Product: ESSENTIO EL DR Pacemaker

Model L121

Product: ESSENTIO MRI EL DR Pacemaker

Model L131

Product: PROPONENT SR Pacemaker

Model L200

Product: PROPONENT DR Pacemaker

Model L201

Product: PROPONENT EL DR Pacemaker

Model L221

Product: PROPONENT VDD SL Pacemaker

Model L209 - NOT APPROVED IN US

Product: PROPONENT MRI Pacemaker

Model's; L210, L211, and L231 - NOT APPROVED IN US

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 78787

Status: Active

Manufacturer: Boston Scientific Corporation

Manufactured In: United States

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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

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