The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2542-2019·Announced 2019-09-25

Boston Scientific Recalls 28 Subcutaneous Implantable Cardioverter Defibrillators

Boston Scientific is recalling 28 EMBLEM S-ICD devices due to accelerated battery depletion. Patients should contact their healthcare provider for evaluation.

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 (ICD) where a performance defect (battery depletion) poses a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

Boston Scientific Corporation is recalling 28 units of the Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEM S-ICD Pulse Generator. The recall involves Model A209 devices with specific serial numbers and use-before dates ranging from July 24, 2019, to July 31, 2019.

The recall is issued because a compromised electrical component may cause accelerated battery depletion, leading to an Elective Replacement Indicator (ERI) or End of Life (EOL) status earlier than expected. This performance issue requires the potential replacement of the device.

The affected devices were distributed nationwide to numerous U.S. states and territories, as well as internationally to many countries. Patients with these specific devices should contact their healthcare provider to discuss the recall and determine if device replacement is necessary.

The recalled product

Product
Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEMTM S-ICD Pulse Generator
Manufacturer
Boston Scientific Corporation
Category
Medical Device — Cardiovascular
Hazard
Affected units
28

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 A209
  • Serial Number (Use Before Date) - 213729 (7/24/2019)
  • 213859 (7/26/2019)
  • 213891 (7/27/2019)
  • 213896 (7/27/2019)
  • 213898 (7/27/2019)
  • 213901 (7/27/2019)
  • 213902 (7/27/2019)
  • 213904 (7/27/2019)
  • 213910 (7/27/2019)
  • 213919 (7/27/2019)
  • 213921 (7/27/2019)
  • 213937 (7/27/2019)
  • 213938 (7/27/2019)
  • 213943 (7/27/2019)
  • 213946 (7/27/2019)
  • 213961 (7/28/2019)
  • 213972 (7/28/2019)
  • 213975 (7/28/2019)
  • 213976 (7/28/2019)

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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