| Class 1 Device Recall Obsidio |  |
Date Initiated by Firm | February 20, 2024 |
Date Posted | March 27, 2024 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-1374-2024 |
Recall Event ID |
94126 |
510(K)Number | K213385 |
Product Classification |
Device, Vascular, for Promoting Embolization - Product Code KRD
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Product | Obsidio Conformable Embolic, Material Numbers (UPN): a) M0013972001010, b) M0013972101010 |
Code Information |
a) M0013972001010, UDI/DI 00191506039332, ALL LOT CODES
b) M0013972101010, UDI/DI 00191506043124, ALL LOT CODES |
Recalling Firm/ Manufacturer |
Boston Scientific Corporation 1 Scimed Pl Maple Grove MN 55311-1565
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For Additional Information Contact | Renee Archie 763-494-1133 |
Manufacturer 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. |
FDA Determined Cause 2 | 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 Cover Letter, Customer Advisory Letter and Sample RVTF, to inform physicians of updated IFU warnings and instruction regarding delivery techniques.
The customer notifications were sent on Friday, October 11, 2024, via delivery using Fed Ex, DHL or other equivalent service.
Accounts are not asked to return affected Obsidio product.
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Quantity in Commerce | 985 units |
Distribution | US |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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510(K) Database | 510(K)s with Product Code = KRD
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