The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2543-2019·Announced 2019-09-25

Boston Scientific Recalls S-ICD Devices Due to Battery Depletion

Boston Scientific is recalling 404 EMBLEM MRI S-ICD devices because a compromised electrical component causes accelerated battery depletion, potentially requiring earlier 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 is classified as FDA Class II. While the hazard involves a life-sustaining device, the source text does not report any injuries, deaths, or hospitalizations, and the issue is a performance degradation (battery depletion) rather than an immediate catastrophic failure. This aligns with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Boston Scientific Corporation is recalling 404 units of the Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEM MRI S-ICD Pulse Generator, Model A219. The recall is due to a compromised performance of an electrical component that causes accelerated battery depletion. This issue may lead to an Elective Replacement Indicator (ERI) or End of Life (EOL) status earlier than expected.

The affected devices were distributed nationwide to numerous U.S. states and territories, as well as internationally to many countries. The specific serial numbers affected range from 213636 to 214085, with use-before dates falling between July 21, 2019, and July 31, 2019.

Patients with these implanted devices should contact their healthcare provider or Boston Scientific to discuss the potential need for device replacement. The recall is classified as FDA Class II, indicating a reasonable probability that the use of the product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEM MRI S-ICD Pulse Generator
Manufacturer
Boston Scientific Corporation
Category
Medical Device — Cardiovascular
Hazard
Affected units
404

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 (20)

  • Model A219
  • Serial Number (Use Before Date) - 213636 (7/21/2019)
  • 213637 (7/21/2019)
  • 213638 (7/21/2019)
  • 213639 (7/21/2019)
  • 213640 (7/21/2019)
  • 213641 (7/21/2019)
  • 213642 (7/21/2019)
  • 213643 (7/21/2019)
  • 213644 (7/21/2019)
  • 213645 (7/21/2019)
  • 213646 (7/21/2019)
  • 213647 (7/21/2019)
  • 213648 (7/21/2019)
  • 213649 (7/21/2019)
  • 213650 (7/21/2019)
  • 213651 (7/21/2019)
  • 213652 (7/21/2019)
  • 213653 (7/21/2019)
  • 213654 (7/21/2019)

Distribution

Distributed nationwide across the United States.

The notice also names 37 states specifically:

Part of a larger recall action

This product is one of 2 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 2 products in this recall →

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