Boston Scientific EMBLEM S-ICD Subcutaneous Defibrillators Software Defect Causes Battery Display Error
Boston Scientific is recalling 7 EMBLEM S-ICD Model A209 subcutaneous defibrillators due to a software defect that displays inaccurate battery capacity information. Patients may not realize when their device's battery requires 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: This is an FDA Class II recall of a life-critical implanted cardiac device with a software defect affecting battery status display. No hospitalizations, injuries, or deaths have been reported. The defect creates a risk of harm if patients cannot accurately monitor their device's battery status, but no actual harm has been documented, placing this at High (Score 3) per the rubric.
Plain-English summary
Boston Scientific Corporation is recalling 7 EMBLEM S-ICD Model A209 subcutaneous implantable defibrillators (serial numbers 169276, 169509, 169645, 169774, 169876, 169671, 169297) due to a software manufacturing date/timestamp error. This defect causes the device to display inaccurate battery capacity information to patients and healthcare providers.
The EMBLEM S-ICD is a life-critical device implanted beneath the skin to monitor heart rhythm and deliver electrical therapy to correct dangerous arrhythmias. Accurate battery status is essential for patients to know when the device requires replacement. An inaccurate battery display may lead patients to be unaware that their device needs replacement before the battery is depleted.
The affected devices were distributed worldwide, including to patients in the United States (Alabama, Arkansas, California, Colorado, Delaware, Georgia, Illinois, Iowa, Massachusetts, Michigan, Minnesota, Nevada, New Jersey, New York, Ohio, Pennsylvania, Tennessee, Texas, and Virginia), Canada, France, Germany, Latvia, Netherlands, Poland, Sweden, Switzerland, and the United Kingdom.
Patients who have been implanted with an EMBLEM S-ICD Model A209 should contact their healthcare provider or Boston Scientific to confirm whether their device is affected and to discuss what monitoring or follow-up may be needed. Do not stop using the device or attempt self-removal. Healthcare providers should verify patient device serial numbers and follow Boston Scientific's guidance for management of affected devices.
The recalled product
- Product
- EMBLEM S-ICD, Subcutaneous Implantable Defibrillators, Model A209, sterile.
- Manufacturer
- Boston Scientific Corporation
- Affected units
- 7
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 (8)
- UPN: 00802526548406
- Serial numbers 169276
- 169509
- 169645
- 169774
- 169876
- 169671
- 169297.
Distribution
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.
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