Use cautionMedical device recall · FDA · Published February 20, 2024
Boston Scientific Obsidio Embolic Recall: High Risk of Bowel Surgery
Boston Scientific recalls Obsidio Conformable Embolic devices with specific material numbers due to high risk of bowel ischemia requiring major surgery during lower GI bleeding procedures.
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.
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Contact the company
📍Recalling firmBoston Scientific Corporation1 Scimed Pl · Maple Grove, MN 55311-1565
“Boston Scientific Obsidio Embolic Recall: High Risk of Bowel Surgery.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/56133-boston-scientific-obsidio-embolic-recall-high-risk-of-bowel-surgery. Based on FDA recall #Z-1374-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1374-2024%22&limit=1).
The FDA announced on Feb. 20, 2024, that Boston Scientific Corporation is recalling Obsidio Conformable Embolic devices due to a high risk of bowel ischemia. Owners should not use the aliquot technique to deliver the device for lower gastrointestinal bleeding embolization procedures.
How to tell if you have it
Brand: Boston Scientific
Product: Obsidio Conformable Embolic
Material Numbers (UPN): M0013972001010, M0013972101010
UDI/DI for M0013972001010: 00191506039332
UDI/DI for M0013972101010: 00191506043124
Lot Codes: All lot codes for both material numbers
Units affected: 985
The hazard
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 common adverse health consequence is the need to perform major surgery such as bowel resection and/or diverting colostomy.
Context
GovInfoNow's records show Boston Scientific Corporation has 124 other recalls on record since June 1, 2017. Other recent recalls of similar products include Boston Scientific Imager II Angiographic Catheters Recall (Aug. 24, 2026), Boston Scientific LUX-Dx Cardiac Monitor System Recall (Aug. 6, 2026), and Boston Scientific StoneSmart Connect Console Power Adapters May Fail Safety Testing (July 22, 2026). Other recent recalls of similar products include Wilson-Cook Instinct Plus Endoscopic Clipping Device Recall (March 3, 2026), AMD Medicom Ritmed Neurological Sponges Recall (May 8, 2026), and Wilson-Cook Teslatome Sphincterotomes Recall (Dec. 18, 2025).
How to tell if you have this one
Check for material numbers M0013972001010 or M0013972101010 on the device. These devices were sold with specific UDI/DI codes and lot numbers.
Brand
Boston Scientific
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Device Details
Identify the material number on the device to determine if it's recalled.
How this recall unfolded
Recall timeline
FDA published this recall 43 days after the firm started it.
1Firm started the recall
2FDA classified it Class I
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1374-2024 (February 20, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1374-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.