OBSIDIO™ M0013972001010Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00191506039332), received between Nov 20, 2023 and Dec 4, 2025 — classified as 2 deaths, 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Migration” (2 reports).

1 FDA recall record name this device's identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Feb 20, 2024Open, Classified

   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.

   Z-1374-2024 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 4, 2025Migration; Migration

  IT WAS REPORTED THAT MIGRATION OCCURRED. OBSIDIO WAS SELECTED FOR USE IN A SPLENIC EMBOLIZATION PROCEDURE. OBSIDIO WAS USED OFF LABEL FOR THE VESSEL SIZE AND TRAVELED OUTSIDE THE DESIRED AREA OCCLUDED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE DESIRED AMOUNT OF OBSIDIO THAT TRAVELED OUTSIDE THE PARAMETERS WAS INTENDED AND PURPOSEFUL AND THE PATIENT DID NOT EXPERIENCE ANY HARM.

  Patient problems: Embolism/Embolus

  MAUDE report 23722659 ↗
• DeathMar 26, 2025Migration; Migration

  IT WAS REPORTED VIA JOURNAL ARTICLE, THAT MIGRATION OCCURRED RESULTING IN PATIENT COMPLICATIONS AND DEATH. OBSIDIO WAS SELECTED FOR AN EMBOLIZATION PROCEDURE OF THE POSTERIOR SUPERIOR PANCREATICODUODENAL ARTERY (PSPDA). THE PATIENT WAS ADMITTED FOR HYPOXEMIC RESPIRATORY FAILURE AND SWEETS SYNDROME, AND THE HOSPITAL COURSE WAS COMPLICATED BY MELENA. THE PATIENTS HEMOGLOBIN DECLINED OVERNIGHT FROM 7.1 TO 5.8 G/DL WITH RECURRENT MELENA AND HEMATEMESIS REQUIRING A BLOOD TRANSFUSION. A COMPUTERIZED TOMOGRAPHY (CT) ANGIOGRAM DEMONSTRATED ACTIVE EXTRAVASATION INTO THE DUODENUM. ANGIOGRAPHY OF THE PSPDA WITH A 2.8 FRENCH NON-BOSTON SCIENTIFIC MICROCATHETER DEMONSTRATED A PSEUDOANEURYSM OF A SMALL BRANCH WHERE SUPER SELECTIVE CATHETERIZATION WAS IMPOSSIBLE. EMBOLIZATION OF THE PSPDA USING OBSIDIO WAS PERFORMED, WITH THE GOAL OF OCCLUDING BRANCHES BEYOND THE REACH OF THE MICROCATHETER. THE ALIQUOT TECHNIQUE WAS UTILIZED TO PRESERVE THE MICROCATHETER FOR LATER USE. WHILE APPLYING A SLOW INJECTION FORCE, 0.2 ML ALIQUOTS OF OBSIDIO WAS FLUSHED WITH A 3 ML SYRINGE AND IOHEXOL, WHICH WAS SURMISED TO BETTER RESEMBLE THE VISCOSITY OF OBSIDIO COMPARED TO NORMAL SALINE. THE EMBOLIC WAS ADMINISTERED U

  Patient problems: Abdominal Pain; Embolism/Embolus; Ischemia; Multiple Organ Dysfunction Syndrome; Necrosis; Pancreatitis; Sepsis

  MAUDE report 21696264 ↗
• DeathFeb 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT DEATH OCCURRED. OBSIDIO WAS SELECTED FOR USE IN A TERMINAL ILEAL BLEED. THE ALIQUOT TECHNIQUE WAS USED WITH CONTRAST AND THE VESSEL SIZE WAS 2MM. THE DEVICE WAS SUCCESSFULLY IMPLANTED INTO TWO BRANCHES OFF OF THE ILEOCOLIC ARTERY. A BOWEL INFARCTION WAS NOTICED ON POST COMPUTERIZED TOMOGRAPHY (CT) IMAGING. APPROXIMATELY FOUR DAYS POST PROCEDURE, THE PATIENT EXPERIENCED PNEUMATOSIS AND UNDERWENT SURGERY FOR A PARTIAL BOWEL RESECTION. THE PATIENT REMAINED HOSPITALIZED UNTIL PASSING AWAY. IT WAS FURTHER REPORTED THAT THE DOCUMENTED CAUSE OF DEATH WAS RESPIRATORY FAILURE AND CARDIAC ARREST.

  Patient problems: Ischemia; Unspecified Tissue Injury

  MAUDE report 18769491 ↗
• InjuryNov 21, 2023Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT OBSIDIO EMBOLIZED. THE TARGET LOCATION WAS IN THE GASTRODUODENAL ARTERY (GDA). THE VESSEL SIZE WAS 1 - 3MM. OBSIDIO WAS SELECTED FOR USE. AFTER CREATING CASTING OF THE OBSIDIO, THE FELLOW WAS INSTRUCTED BY THE PHYSICIAN TO ADMINISTER A LARGE BOLUS OF SALINE AND OBSIDIO MATERIAL THROUGH ALIQUOT TECHNIQUE. THE REASON FOR THE USE OF THE ALIQUOT METHOD WAS TO RE-USE THE MICROCATHETER. THE ALIQUOT METHOD RESULTED IN A TOTAL OF .6 ML OF OBSIDIO BEING USED AND THE CATHETER, IN USE, BEING PLACED TOO CLOSE TO THE OBSIDIO CASTING. THE OBSIDIO FROM THE SECOND BOLUS/ALIQUOT, MOVED TOWARDS THE BRANCH POINT OF THE RIGHT HEPATIC ARTERY. THE FLOW OF THE VESSEL AND INJECTION OF CONTRAST DURING A HAND INJECTION RUN TOOK THE OBSIDIO EVEN MORE DISTAL. THE OBSIDIO SHUT DOWN THE RIGHT HEPATIC ARTERY SUPPLY. ACTION WAS TAKEN TO BREAK UP THE OBSIDIO INTO PIECES USING A MICROCATHETER. SMALLER PIECES OF OBSIDIO TRAVELED DISTALLY TO THE PANCREAS. MINOR FLOW WAS ACHIEVED BUT NOT ENTIRELY. IMAGING, POST PROCEDURE, REVEALED THE PATIENT HAD PANCREAS FLOW SHUT DOWN RESULTING INTO OTHER COMPLICATIONS LIKE PANCREAS INFARCT.

  Patient problems: Embolism/Embolus; Obstruction/Occlusion

  MAUDE report 18184607 ↗
• InjuryNov 20, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT THE OBSIDIO BROKE OFF AND EMBOLIZED. THE TARGET LOCATION WAS IN THE GASTRODUODENAL ARTERY (GDA). THE VESSEL SIZE WAS 2.0 - 2.7 MM. OBSIDIO WAS SELECTED FOR USE. AFTER OBSIDIO WAS ADMINISTERED, THE MICROCATHETER WAS LEFT IN PLACE FOR A FEW MINUTES PRIOR TO REMOVING IT. A PIECE OF OBSIDIO BROKE OFF AND TRAVELED TO APPROXIMATELY 1CM AWAY FROM THE OSTIUM. THE TARGET LOCATION WAS BACKFILLED WITH AN EMBOLD FIBERED COIL, AND THE OBSIDIO REMAINED STABLE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: Embolism/Embolus

  MAUDE report 18176969 ↗