EMBOLD™ Soft M001394250020040Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00191506026370), received between Oct 3, 2024 and Jan 22, 2026 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 22, 2026Migration

  IT WAS REPORTED THAT THE COIL MIGRATED POST-DEPLOYMENT. AN EMBOLD SOFT 2 X 4 COIL WAS SELECTED FOR USE DURING A GASTROINTESTINAL (GI) BLEED PROCEDURE. THE VESSEL WAS MILDLY TORTUOUS, AND THE COIL FULLY DEPLOYED WITHOUT ANY ISSUES. WHILE ATTEMPTING TO ACCESS ANOTHER BRANCH USING A .014 NON-BOSTON SCIENTIFIC WIRE, THE WIRE INADVERTENTLY ENTERED THE WRONG BRANCH AND HOOKED THE DEPLOYED COIL, RESULTING IN COIL DISLODGEMENT. THE ENTIRE SYSTEM, INCLUDING THE MICROCATHETER AND BASE CATHETER, WAS WITHDRAWN AND FLUSHED; HOWEVER, THE COIL COULD NOT INITIALLY BE LOCATED. UPON REINSERTION OF THE BASE CATHETER, THE COIL WAS VISUALIZED UNDER FLUOROSCOPY PROTRUDING FROM THE SIDE HOLE OF THE BASE CATHETER AND WAS SUCCESSFULLY RETRIEVED. PRIOR TO THIS ISSUE, OTHER EMBOLD COILS HAD BEEN SUCCESSFULLY IMPLANTED; THEREFORE, THE PROCEDURE WAS COMPLETE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24151051 ↗
• MalfunctionJul 30, 2025Difficult to Remove; Migration; Difficult to Remove; Migration

  IT WAS REPORTED THAT THE COIL MIGRATED POST DEPLOYMENT. A 2MM X 4CM EMBOLD SOFT COIL WAS SELECTED FOR USE IN A PROSTATIC ARTERY EMBOLIZATION (PAE) PROCEDURE. THE VESSEL WAS 2-3MM, AND THE TORTUOSITY WAS MODERATE TO SEVERE. DURING THE PROCEDURE, THE COIL COULD NOT BE RETRACTED BACK INTO THE MICROCATHETER. THE COIL WAS DEPLOYED, AND IT WAS CONSIDERED SUCCESSFUL, BUT AFTERWARDS THE COIL MOVED OUT OF POSITION INTO THE SUPERIOR GLUTEAL ARTERY. THE COIL WAS PULLED OUT WITH THE SHEATH. AFTER RETRIEVING THE COIL, THE PHYSICIAN DECIDED TO CLOSE AND COME BACK ANOTHER DAY GIVEN THE EVENTS. ONLY ONE SIDE OF THE PROCEDURE WAS TREATED SUCCESSFULLY; THIS SIDE WAS NOT. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22668553 ↗
• InjuryOct 3, 2024Break; Separation Failure; Break; Separation Failure

  IT WAS REPORTED THAT THE COIL WAS DIFFICULT TO DEPLOY, REQUIRING A SNARE TO REMOVE. TWO 2X4 EMBOLD SOFT DETACHABLE COIL SYSTEMS WAS SELECTED FOR USE DURING A BLEED COILING PROCEDURE. DURING THE PROCEDURE, THE COIL WAS DIFFICULT TO DEPLOY IN THE MILD TO MODERATELY TORTUOUS TARGET LOCATION. SEVERAL ATTEMPTS WERE MADE TO DEPLOY THE COIL, BUT DIFFICULTY WAS ENCOUNTERED DUE TO SMALL VASCULATURE. IT WAS NOTED THAT THE PULL WIRE/DETACHMENT WIRE WAS BROKEN. A SNARE WAS USED TO RETRIEVE THE COIL, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20359284 ↗
• InjuryOct 3, 2024Break; Separation Failure; Break; Separation Failure

  IT WAS REPORTED THAT THE COIL WAS DIFFICULT TO DEPLOY, REQUIRING A SNARE TO REMOVE. TWO 2X4 EMBOLD SOFT DETACHABLE COIL SYSTEMS WAS SELECTED FOR USE DURING A BLEED COILING PROCEDURE. DURING THE PROCEDURE, THE COIL WAS DIFFICULT TO DEPLOY IN THE MILD TO MODERATELY TORTUOUS TARGET LOCATION. SEVERAL ATTEMPTS WERE MADE TO DEPLOY THE COIL, BUT DIFFICULTY WAS ENCOUNTERED DUE TO SMALL VASCULATURE. IT WAS NOTED THAT THE PULL WIRE/DETACHMENT WIRE WAS BROKEN. A SNARE WAS USED TO RETRIEVE THE COIL, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20359278 ↗