The Recall Desk

FDA (Devices) recall action 83558

Boston Scientific Corporation recalled 2 products on 2019-09-25

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2019-09-25
Critical
0
Units
432

Why these products were recalled

Potential need for device replacement - Elective Replacement Indicator (ERI) or End of Life (EOL) - earlier than expected due to compromised performance of an electrical component causing accelerated battery depletion.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–2 of 2

  • HighFDA (Devices)··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.

    Product
    Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEM MRI S-ICD Pulse Generator
    Category
    Distribution
    37 states
  • HighFDA (Devices)··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.

    Product
    Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEMTM S-ICD Pulse Generator
    Category
    Distribution
    37 states