Obsidio Conformable Embolic coils recalled for bowel-ischemia risk
Boston Scientific recalled 985 Obsidio Conformable Embolic coils because using the aliquot delivery technique for lower GI bleeding poses a high risk of bowel ischemia requiring major surgery.
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: FDA Class I recall with high-risk safety issue: the aliquot delivery technique poses a risk of bowel ischemia requiring major surgery (bowel resection or diverting colostomy), representing serious injury risk.
Plain-English summary
Boston Scientific Corporation has recalled 985 units of Obsidio Conformable Embolic coils (UPNs M0013972001010 and M0013972101010). The recall affects devices distributed in the US.
An FDA investigation determined that delivery of the Obsidio embolic using the aliquot technique for lower gastrointestinal bleeding embolization poses a high risk of bowel ischemia, a condition in which part of the bowel loses its blood supply. The most serious and most common adverse health consequence is the need for major surgery, such as bowel resection or diverting colostomy.
Boston Scientific does not recommend using the aliquot technique to deliver Obsidio devices for lower GI bleed embolization procedures. Healthcare providers should review their use of this device and delivery technique accordingly.
The recalled product
- Product
- Obsidio Conformable Embolic, Material Numbers (UPN): a) M0013972001010, b) M0013972101010
- Manufacturer
- Boston Scientific Corporation
- Affected units
- 985
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 (5)
- a) M0013972001010
- UDI/DI 00191506039332
- ALL LOT CODES b) M0013972101010
- UDI/DI 00191506043124
- ALL LOT CODES
Distribution
Distribution scope not specified by the agency.
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