Boston Scientific Recalls Emblem MRI S-ICD Devices Due to Electrical Overstress
Boston Scientific is recalling 872 Emblem MRI S-ICD Model A219 devices because electrical overstress may lead to device malfunction.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class I, which mandates a severity score of at least 4 per the rubric, as it indicates a reasonable probability of serious adverse health consequences or death.
Plain-English summary
Boston Scientific Corporation is recalling 872 units of the Emblem MRI S-ICD Model A219. The recall is being conducted because electrical overstress may lead to device malfunction.
The affected devices were distributed throughout the United States and worldwide, with foreign distribution made to Canada and other countries. The specific serial numbers affected are listed in the official recall documentation.
Consumers and healthcare providers should contact Boston Scientific Corporation for further instructions on how to proceed with the recall and replacement of the affected devices.
The recalled product
- Product
- EMBLEM MRI S-ICD Model A219
- Manufacturer
- Boston Scientific Corporation
- Affected units
- 872
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)
- Serial numbers: 100641
- 200266
- 200291
- 200317
- 200347
- 200348
- 200359
- 200368
- 200369
- 200375
- 200378
- 200431
- 200479
- 200481
- 200631
- 200762
- 200786
- 200787
- 200818
- 200821
Distribution
Distribution scope not specified by the agency.
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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