Recall Z-1374-2024— Boston Scientific Corporation
Class I · Ongoing
Class I FDA medical device recall by Boston Scientific Corporation, initiated 2024-02-20. It names one FDA 510(k) clearance: K213385. Product: Obsidio Conformable Embolic, Material Numbers (UPN): a) M0013972001010, b) M0013972101010. Reason: 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..
- Recalling firm
- Boston Scientific Corporation
- Classification
- Class I
- Status
- Ongoing
- Initiated
- 2024-02-20
- Firm location
- Maple Grove, MN, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Obsidio Conformable Embolic, Material Numbers (UPN): a) M0013972001010, b) M0013972101010
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.