EMBOLD™ Fibered M001394240030060Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08714729983545), received between Apr 12, 2024 and Feb 11, 2026 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Stretched” (3 reports).

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 11, 2026Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PUSHER WIRE FRACTURED AND ADDITIONAL INTERVENTION WAS REQUIRED. AN EMBOLD FIBERED 3X6 WAS SELECTED FOR USE IN A PELVIC EMBOLIZATION PROCEDURE. THE COIL WAS ADVANCED TO THE TARGET LESION AND THE PROXIMAL RELEASE PERFORATION WAS BROKEN TO DEPLOY THE COIL. AT THIS POINT, THE PHYSICIAN NOTICED RADIO OPAQUE MARKERS IN THE DISTAL SEGMENT OF CATHETER AND SAW THAT THE COIL PUSHER WIRE HAD BROKEN OFF AND WAS STILL ATTACHED TO COIL. THE PHYSICIAN PULLED THE ENTIRE MICROCATHETER SYSTEM AND INSERTED A MICROSNARE TO SNARE THE COIL AND PUSHER WIRE FRAGMENT. THE DEVICE FRAGMENT AND THE COIL WERE SUCCESSFULLY SNARED IN THE UNKNOWN 5 FR CATHETER AND THE ENTIRE SYSTEM WAS REMOVED FROM THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24313841 ↗
• InjuryFeb 2, 2026Premature Activation; Stretched

  IT WAS REPORTED THAT THE COIL PREMATURELY DEPLOYED WITHIN THE PATIENT, REQUIRING ADDITIONAL INTERVENTION. AN EMBOLD? FIBERED 3X6 WAS SELECTED FOR USE TO TREAT A BLEED IN THE UTERINE ARTERIES FOLLOWING A HYSTERECTOMY. THE RIGHT UTERINE ARTERY WAS SUCCESSFULLY TREATED WITH AN EMBOLD? FIBERED 2X4 AND A NON-BOSTON SCIENTIFIC (BSC) MICROCATHETER. THE LEFT UTERINE ARTERY WAS FIRST TREATED WITH AN EMBOLD? FIBERED 2X4. WHILE POSITIONING THE EMBOLD? FIBERED 3X6, THE PHYSICIAN RETRACTED THE COIL. MIDWAY THROUGH RETRACTION, THE PHYSICIAN FELT A "POP", AND THE COIL PREMATURELY DEPLOYED, PARTLY WITHIN THE PATIENT'S VASCULATURE AND PARTLY WITHIN THE NON-BSC MICROCATHETER. USING A SNARE, THE PHYSICIAN WAS SUCCESSFULLY ABLE TO REMOVE THE ENTIRETY OF THE STRETCHED EMBOLD? FIBERED 3X6. THE PHYSICIAN DETERMINED THAT THE VESSEL WAS SUFFICIENTLY OCCLUDED, AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24239834 ↗
• MalfunctionFeb 19, 2025Failure to Advance; Failure to Advance

  REPORTABLE BASED OFF DEVICE ANALYSIS COMPLETED ON 23JAN2025. AN EMBOLD FIBERED 3X6 WAS SELECTED FOR USE. DURING ADVANCEMENT, IT WAS REPORTED THAT THE COIL WAS UNABLE TO ADVANCE THROUGH THE MICROCATHETER. THE COIL WAS IRRIGATED, REMOVED, AND ADVANCEMENT WAS ATTEMPTED ONCE AGAIN, BUT WAS UNSUCCESSFUL. THE DEVICE WAS REMOVED FROM THE PATIENT AND ANOTHER COIL WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED PATIENT COMPLICATIONS. HOWEVER, DEVICE ANALYSIS REVEALED THE COUPLER WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21414492 ↗
• InjuryOct 29, 2024Premature Activation; Difficult to Remove; Stretched; Difficult to Advance; Adverse Event Without Identified Device or Use Problem; Premature Activation; Difficult to Remove; Stretched; Difficult to Advance; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ADDITIONAL INTERVENTION WAS REQUIRED TO RETRIEVE THE COIL. AN EMBOLD FIBERED DETACHABLE COIL SYSTEM WAS SELECTED FOR USE IN A RENAL EMBOLIZATION PROCEDURE. THE TARGET VESSEL WAS REPORTED TO BE MILDLY TORTUOUS. DURING THE PROCEDURE, THERE WAS DIFFICULTY EXPERIENCED BOTH ADVANCING THE COIL WITHIN THE MICROCATHETER AND WITHDRAWING FROM THE MICROCATHETER. ALTHOUGH THE PROXIMAL RELEASE MECHANISM WAS NOT BROKEN, THE COIL STRETCHED AND DEPLOYED WITHIN THE PATIENT PREMATURELY. AS A RESULT, A SNARE WAS USED TO REMOVE THE COIL FROM THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING AN ALTERNATE EMBOLIZATION DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THE INTERVENTION.

  Patient problems: Muscle Weakness/Atrophy; Nausea; No Clinical Signs, Symptoms or Conditions; Pain; Sepsis; Unspecified Infection; Unspecified Kidney or Urinary Problem; Vomiting

  MAUDE report 20558397 ↗
• InjuryJun 25, 2024Failure to Advance; Material Protrusion/Extrusion; Failure to Advance; Material Protrusion/Extrusion

  IT WAS REPORTED THAT THE COIL PROTRUDED FROM THE TARGET LOCATION. A 3X6 EMBOLD FIBERED DETACHABLE COIL SYSTEM WAS SELECTED FOR AN EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA). IT WAS NOTED THAT THE COIL WOULD NOT ADVANCE THROUGH THE CATHETER AT FIRST, BUT IT WAS RE-SHEATHED AND RE-USED SUCCESSFULLY. PRIOR TO COIL DEPLOYMENT, NOTHING LOOKED UNUSUAL. IT WAS SEATED NORMALLY; HOWEVER, AFTER DEPLOYMENT AND REMOVING THE PUSHER WIRE, SOMETHING WAS LEFT STICKING OUT OF THE GDA INTO THE COMMON HEPATIC ARTERY. THE DEVICE WAS SNARED AND THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19610363 ↗
• InjuryApr 12, 2024Break; Stretched; Difficult to Advance; Break; Stretched; Difficult to Advance

  IT WAS REPORTED THAT THE COIL FRACTURED DURING DEPLOYMENT AND ADDITIONAL INTERVENTION WAS REQUIRED. A 3X6 EMBOLD FIBERED DETACHABLE COIL SYSTEM WAS SELECTED FOR USE IN A SUPERIOR RECTAL ARTERY EMBOLIZATION PROCEDURE. THE VESSEL WAS MILDLY TORTUOUS. SEVERAL EMBOLD COILS WERE PLACED WITHOUT ISSUE. WHILE ADVANCING THE FINAL EMBOLD COIL, THERE WAS RESISTANCE ENCOUNTERED. THE COIL WAS RE-SHEATHED, AND ADVANCEMENT WAS ATTEMPTED FOR A SECOND TIME, WHICH WENT MORE SMOOTHLY. WHEN THE COIL WAS DEPLOYED, IT STRETCHED AND BROKE OFF, WITH A PORTION OF THE COIL DEPLOYING INTO THE ARTERY AND A PORTION REMAINING WITHIN THE MICROCATHETER. THE FRACTURED PIECE OF THE COIL THAT WAS WITHIN THE ARTERY WAS SNARED OUT. ALL PIECES OF THE DEVICE WERE SUCCESSFULLY REMOVED FROM THE PATIENT. THERE WERE NO REPORTED PATIENT COMPLICATIONS AND THE PATIENT FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19095914 ↗