Obsidio Conformable Embolic, Material Numbers (UPN): a) M0013972001010, b) M0013972101010
Published April 3, 2024 · Recall initiated: February 20, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
An investigation determined that delivery of the Obsidio embolic using the aliquot technique for lower gastrointestinal bleeding embolization poses a high risk of bowel ischemia. The most serious and the most common adverse health consequence, reasonably foreseeable to occur, is the need to perform major surgery such as bowel resection and/or diverting colostomy. Therefore, Boston Scientific does not recommend that the aliquot technique be used to deliver the Obsidio device for lower GI bleed embolization procedures.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Boston Scientific Corporation
- Distributor
- US
- Lot
- a) M0013972001010, UDI/DI 00191506039332, ALL LOT CODES b) M0013972101010, UDI/DI 00191506043124, ALL LOT CODES
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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