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.
Boston Scientific is recalling certain Obsidio Conformable Embolic devices used for lower gastrointestinal bleeding. Using these devices with the aliquot technique poses a high risk of bowel ischemia that may require major surgery like bowel resection or colostomy.
The aliquot technique used to deliver the Obsidio embolic device for lower GI bleeding can cause bowel ischemia. This may lead to serious complications requiring major surgery such as bowel resection or colostomy creation.
Healthcare providers using the Obsidio device for lower GI bleeding procedures are affected. Patients undergoing these procedures with the recalled devices are at risk of needing major bowel surgery.
Check for material numbers M0013972001010 or M0013972101010 on the device. These devices were sold with specific UDI/DI codes and lot numbers.
Identify the material number on the device to determine if it's recalled.
Boston Scientific determined that using the aliquot technique with these devices for lower GI bleeding poses a high risk of bowel ischemia requiring major surgery.
The aliquot technique used to deliver the Obsidio device can cause bowel ischemia, which may require bowel resection or colostomy.
Look for material numbers M0013972001010 or M0013972101010 on the device.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-1374-2024 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-1374-2024 from Boston Scientific. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
