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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 Obsidiosee related information
Date Initiated by FirmFebruary 20, 2024
Date PostedMarch 27, 2024
Recall Status1 Open3, Classified
Recall NumberZ-1374-2024
Recall Event ID 94126
510(K)NumberK213385 
Product Classification Device, Vascular, for Promoting Embolization - Product Code KRD
ProductObsidio 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 ContactRebecca 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
ActionBoston 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 Commerce985 units
DistributionUS
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = KRD
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