The Recall Desk
Agency classClass IIOur severity:SevereFDA (Devices)·Z-3257-2018·Announced 2018-10-03

Boston Scientific Recalls ACCOLADE Pacemakers Due to Battery Depletion Risk

Boston Scientific is recalling specific ACCOLADE pacemakers and CRT-P systems due to an elevated potential for early replacement caused by hydrogen-induced accelerated battery depletion.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a 'Severe' rating under the rubric, particularly given the risk of early battery depletion in a life-sustaining medical device.

Plain-English summary

Boston Scientific Corporation has initiated a recall for a subset of active ACCOLADE pacemaker and CRT-P systems. The recall is due to an identified elevated potential for early pacemaker replacement resulting from hydrogen-induced accelerated battery depletion.

The affected devices include the 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. These devices were distributed across numerous U.S. states and Puerto Rico, including 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, WA, WI, WV, and WY.

Patients with these devices should contact their healthcare provider or Boston Scientific to determine if their specific device is affected and to discuss appropriate monitoring or replacement options.

The recalled product

Product
ACCOLADE Pacemaker
Manufacturer
Boston Scientific Corporation
Category
Medical Device — Cardiac Pacemaker
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (5)

  • 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.

Distribution

Distributed in 48 states:

Part of a larger recall action

This product is one of 5 recalled by Boston Scientific Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 5 products in this recall →

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