The Recall Desk
HighFDA (Devices)·Z-0823-2025·Announced 2025-01-22

PROPONENT DR Pacemaker Recalled for Unexpected Safety Mode Risk

Boston Scientific is recalling certain PROPONENT DR pacemakers built before September 2018 due to latent battery impedance that could cause unexpected Safety Mode initiation during normal operation.

What this means for you

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: FDA Class I medical device recall for latent defect with no reported injuries. The hazard (unexpected Safety Mode initiation) is potential rather than reported, and per rubric, such risk-of-harm recalls without reported illness score at most 3.

Plain-English summary

Boston Scientific is recalling certain PROPONENT DR pacemakers (models L201, L209, L211, L221, L231) manufactured before September 2018. Approximately 59,937 units were distributed in the U.S., with additional units distributed to U.S. territories and other locations including Guam and the Northern Mariana Islands, totaling 156,329 affected units.

The recalled devices may experience an increased potential to initiate Safety Mode during telemetry or normal higher-power operations due to latent high battery impedance. Safety Mode is a protective mechanism that, if activated unexpectedly during routine pacing operations, could interrupt normal device function.

Patients can identify whether their device is affected by checking their device's model number, UDI code, and serial number against the detailed recall information provided by the FDA. Further guidance regarding affected devices may be obtained from Boston Scientific or by consulting the official FDA recall documentation.

The recalled product

Product
PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L211), EL (Model Number L221), and EL MRI (Model Number L231).
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 (10)

  • L201 - UDI-DI: 00802526559044
  • 00802526578014
  • 00802526576379
  • 00802526576874
  • L209 - UDI-DI: 00802526559068
  • 00802526576386
  • L211 - UDI-DI: 00802526578038
  • 00802526559105
  • 00802526576409
  • 00802526576904

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

Part of a larger recall action

This product is one of 6 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 6 products in this recall →

Related recalls

Same manufacturer · Boston Scientific Corporation

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Same hazard · battery impedance

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