Boston Scientific Recalls EMBLEM S-ICD Model A209 Due to Electrical Overstress
Boston Scientific is recalling 1,953 EMBLEM S-ICD Model A209 devices because electrical overstress may cause malfunction. The devices were distributed in the US and worldwide.
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 FDA has classified this recall as Class I. According to the severity rubric, an FDA Class I recall must be scored as at least 4 (Severe), as it indicates a reasonable probability of serious adverse health consequences.
Plain-English summary
Boston Scientific Corporation is recalling 1,953 units of the EMBLEM S-ICD Model A209. The recall is due to a potential electrical overstress issue that may lead to device malfunction. The affected devices were distributed throughout the United States and worldwide, including Canada and other countries.
The source text does not specify the number of patients affected or report any illnesses or injuries associated with this recall. The specific serial numbers for the affected units are listed in the official FDA recall record Z-0950-2021.
Patients with these devices should contact their healthcare provider or Boston Scientific for further instructions on how to proceed. The FDA has classified this recall as Class I, indicating a reasonable probability that the use of, or exposure to, the violative product will cause serious adverse health consequences or death.
The recalled product
- Product
- EMBLEM S-ICD Model A209
- Manufacturer
- Boston Scientific Corporation
- Affected units
- 1,953
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: 104254
- 104259
- 104277
- 104292
- 104299
- 104304
- 104305
- 104307
- 104310
- 104322
- 104331
- 104339
- 104340
- 104341
- 104348
- 104349
- 104351
- 104355
- 104356
- 104357
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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