Recall Z-1374-2024 ยท KRD Device, Vascular, For Promoting Embolization
Boston Scientific Corporation
Obsidio Conformable Embolic, Material Numbers (UPN): a) M0013972001010, b) M0013972101010
| Date | Mar 27, 2024 (initiated Feb 20, 2024) |
| Status | Open, Classified |
| 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. |
| Root cause | Under Investigation by firm |
| Action | Boston Scientific issued an URGENT MEDICAL DEVICE PRODUCT ADVISORY notice to its consignees via FedEx on 02/21/2024. The notice explained the use of the aliquot technique in not recommended for lower GI bleed embolization procedure due to the risk to the patient. The firm directed the consignee to immediately post the notice near the product to ensure the information is easily accessible to all users. For questions, please contact your local Boston Scientific Representative. Updated recall strategy: All Obsidio accounts were sent an updated Product Advisory, which includes the Customer |
| Quantity | 985 units |
| Distribution | US |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K213385 | GEM Obsidio, Inc., Jul 1, 2022 |