Implantable Defibrillator Software Error Causes Inaccurate Battery Display
Boston Scientific's EMBLEM MRI S-ICD implantable defibrillators contain a software defect with an incorrect manufacturing date that causes inaccurate battery capacity display. The recall affects 142 devices distributed worldwide.
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 a risk-of-harm implantable medical device with a confirmed software defect affecting critical battery status information. Although the device is classified as FDA Class II, the source text contains no reports of illness, injury, or hospitalization. Per the rubric, risk-of-harm products without reported injuries score at most 3.
Plain-English summary
Boston Scientific Corporation is recalling 142 units of the EMBLEM MRI S-ICD, a subcutaneous implantable defibrillator (S-ICD), Model A219, due to a software defect.
The device contains an incorrect manufacturing date and timestamp in its software, which causes the device to display battery capacity inaccurately. This means patients may not have accurate information about their device's remaining battery life.
The affected devices are distributed worldwide, including in 19 US states (AL, AR, CA, CO, DE, GA, IL, IA, MA, MI, MN, NV, NJ, NY, OH, PA, TN, TX, and VA), and in Canada, France, Germany, Latvia, Netherlands, Poland, Sweden, Switzerland, and the United Kingdom.
Patients with an affected device should contact their healthcare provider or Boston Scientific for guidance on monitoring their device. Do not attempt to address this issue on your own. Your cardiologist or healthcare provider can advise you on next steps.
The recalled product
- Product
- EMBLEM MRI S-ICD, Subcutaneous Implantable Defibrillator, Model A219, sterile.
- Manufacturer
- Boston Scientific Corporation
- Affected units
- 142
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)
- UPN: 00802526584404
- Serial numbers: 169280
- 169298
- 169494
- 169753
- 169776
- 169934
- 169941
- 170003
- 169547
- 169151
- 169315
- 169514
- 169851
- 169879
- 169292
- 169696
- 169786
- 169788
- 169852
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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