The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-3259-2018·Announced 2018-10-03

Boston Scientific Recalls VISIONIST X4 CRT-P Pacemakers Due to Battery Depletion

Boston Scientific is recalling VISIONIST X4 CRT-P pacemakers because hydrogen-induced accelerated battery depletion may require early replacement.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a high-risk medical device (pacemaker) with a functional defect (battery depletion) that poses a risk of harm, but the source text does not report any specific injuries, illnesses, or fatalities, fitting the criteria for a High severity score.

Plain-English summary

Boston Scientific Corporation is recalling a subset of active VISIONIST X4 CRT-P (Cardiac Resynchronization Therapy Pacemaker) systems. The recall is due to an identified elevated potential for early pacemaker replacement caused by hydrogen-induced accelerated battery depletion.

The affected devices are the VISIONIST X4 (CRT-P) model U228. These pacemakers 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 specific pacemaker models should contact their healthcare provider or Boston Scientific to determine if their device is affected and to discuss necessary monitoring or replacement options.

The recalled product

Product
VISIONIST X4 CRT-P (Cardiac Resynchronization Therapy Pacemaker)
Manufacturer
Boston Scientific Corporation
Category
Medical Device — 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 (1)

  • VISIONIST X4 (CRT-P) model U228

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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