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U.S. Department of Health and Human Services

Class 1 Device Recall Obsidio

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  Class 1 Device Recall Obsidio see related information
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
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
For Additional Information Contact Rebecca KinKead Rubio
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.
Quantity in Commerce 985 units
Distribution US
Total Product Life Cycle TPLC Device Report
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.
510(K) Database 510(K)s with Product Code = KRD and Original Applicant = Obsidio, Inc.
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