EMBOLD™ Fibered M001394240040150Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 08714729983576), received between Aug 1, 2022 and Aug 6, 2026 — classified as 4 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryAug 6, 2026Break; Premature Activation; Stretched; Malposition of Device; Difficult to Advance; Adverse Event Without Identified Device or Use Problem

  It was reported that the coil detached requiring intervention, and there were unretrieved device fragments. A 4mm x 15cm EMBOLD? Fibered coil was selected for use in an embolization procedure to treat a bleed. The vessel was mildly tortuous. During the procedure, difficulty advancing was noted, and the coil detached and fell apart in the 130cm TruSelect microcatheter while the coil was half in the vasculature and half in the microcatheter. The proximal release perforation was not broken. The coil was deployed into the gastroduodenal artery (GDA) while prolapsing into the common, proper and right hepatic arteries, which it subsequently thrombosed. Most of the coil was retrieved with a snare, but there was a stringy portion that was coming off the end of it and detached. Most of that portion was retrieved too, but it was too late for the common hepatic, proper hepatic, and GDA, which were all completely thrombosed. The majority of the device fragments were removed during the procedure, and there is no plan to remove any fragments that remain. It was also noted that the procedure was aborted because of diffuse vessel thrombosis / dissection. The patient was in stable condition and dis

  Patient problems: Foreign Body In Patient; Thrombosis/Thrombus; Vascular Dissection

  MAUDE report 50168455 ↗
• MalfunctionApr 23, 2026Failure to Advance; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2026. IT WAS REPORTED THAT THE COIL WOULD NOT ADVANCE THROUGH THE SHEATH. A 4X15 EMBOLD FIBERED COIL WAS SELECTED FOR AN EMBOLIZATION PROCEDURE. DURING THE PROCEDURE, THE COIL WOULD NOT ADVANCE THROUGH THE SHEATH AND KEPT GETTING STUCK. SEVERAL ATTEMPTS, TO ADVANCE THE COIL, WERE MADE BUT NONE WERE SUCCESSFUL. THE COIL WAS REMOVED FROM THE PATIENT. AN ALTERNATE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. HOWEVER, DEVICE ANALYSIS REVEALED THE COIL DETACHED AND SEPARATED FROM THE DELIVERY SYSTEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24971626 ↗
• MalfunctionFeb 4, 2026Break; Difficult to Remove

  IT WAS REPORTED THAT THE COIL BROKE INTERNAL TO THE PATIENT. AN EMBOLD FIBERED 4X15 WAS SELECTED FOR USE IN THE COILING PROCEDURE. THE TARGET VESSEL WAS MODERATE TO SEVERELY TORTUOUS. DURING THE PROCEDURE, UPON RETRACTION INTO AN UNKNOWN 0.035 MICROCATHETER, THE COIL CAME APART. THE COIL PIECES WERE REMOVED FROM THE PATIENT AND DISPOSED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24260738 ↗
• InjuryNov 21, 2025Stretched; Material Protrusion/Extrusion; Stretched; Material Protrusion/Extrusion

  IT WAS REPORTED THAT THE COIL STRETCHED AND PROTRUDED FROM THE TARGET LOCATION, REQUIRING INTERVENTION. AN EMBOLD FIBERED 4X15 WAS SELECTED TO TREAT A PSEUDO ANEURYSM THAT MEASURED 2.5 CENTIMETERS (CM) IN THE INTERNAL MAMMARY ARTERY. THE RIGHT RADIAL ACCESS WAS A 65 CM RIM CATHETER AND A 105 CM TRUSELECT WAS USED. A 4X15 EMBOLD FIBERED "COIL" WAS SUCCESSFULLY PLACED IN THE TARGET VESSEL WITH NO ISSUES. THEN IT WAS ATTEMPTED TO PLACE A SECOND EMBOLD FIBERED COIL. HOWEVER, THE COIL HAD STRETCHED AND PROTRUDED OUT OF THE MAMMARY ARTERY TO THE SHEATH. THE MICROCATHETER WAS REMOVED, AND THE 5 FRENCH BASE CATHETERS REMAINED. A BASKET-TYPE SNARE WAS ATTEMPTED TO RETRIEVE THE COIL UNSUCCESSFULLY. COMPETITIVE COILS WERE THEN USED TO COMPLETE THE PROCEDURE. THE PATIENT WAS BROUGHT BACK THE NEXT DAY FOR ANOTHER PROCEDURE WHERE A STENT WAS PLACED TO ATTEMPT TO MITIGATE WHAT OF THE COIL THAT HAD EXTENDED DOWN THE RADIAL ACCESS PATHWAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23621719 ↗
• MalfunctionMay 19, 2025Break; Break

  IT WAS REPORTED THAT THE COIL BROKE. THE 90% STENOSED TARGET LESION WAS LOCATED IN A MILDLY TORTUOUS AND MILDLY CALCIFIED LUMBAR ARTERY. AN EMBOLD FIBERED 4X15 WAS SELECTED TO TREAT AN ANEURYSM. AFTER UNPACKING THE EMBOLD, HOWEVER, IT WAS DISCOVERED TO BE BROKEN AT THE DETACHABLE PORTION. A NEW EMBOLD WAS USED TO COMPLETE THE PROCEDURE, AND THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22044589 ↗
• InjuryMay 5, 2025Break; Stretched; Material Integrity Problem; Break; Stretched; Material Integrity Problem

  IT WAS REPORTED THAT THE COIL BROKE REQUIRING ADDITIONAL INTERVENTION TO REMOVE PORTIONS OF THE COIL. A 4MM X 15CM EMBOLD FIBERED COIL WAS SELECTED FOR USE IN A COIL EMBOLIZATION PROCEDURE TO TREAT A BLEED IN A 3MM MODERATELY TORTUOUS SPLENIC ARTERY. THE PHYSICIAN DID NOT LIKE THE WAY THE COIL WAS FORMING IN THE VESSEL AND WENT TO BRING IT BACK INTO THE MICROCATHETER. A "POP" WAS FELT AND THE COIL BROKE WHILE INSIDE THE CATHETER. THE PHYSICIAN ASSUMED THE COIL DEPLOYED. IT WAS THEN DETERMINED THAT THE COIL STRETCHED FROM THE HEPATIC ARTERY TO THE AORTA. SOME PORTIONS OF THE STRETCHED COIL WERE REMOVED USING A SNARE AND SOME PORTIONS REMAINED INSIDE THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 21961895 ↗
• InjurySep 14, 2022Break; Difficult to Remove; Material Separation; Material Deformation; Break; Difficult to Remove; Material Separation; Material Deformation

  IT WAS REPORTED THAT THERE WAS AN UNRETRIEVED DEVICE FRAGMENT. A 4MM X 15MM EMBOLD FIBERED DETACHABLE COIL SYSTEM WAS SELECTED FOR USE IN A SPLENIC PSEUDOANEURYSM EMBOLIZATION PROCEDURE. THE SPLENIC ARTERY WAS MODERATELY TORTUOUS, AND THERE WERE A LOT OF ISSUES WITH BASE STABILITY. EVENTUALLY, A TRUSELECT CATHETER WAS PLACED DISTAL TO THE PSEUDOANEURYSM, AND COILING BEGAN WITH 5MM EMBOLDS. NEXT, A 10MM X 20MM EMBOLD WAS PLACED DESPITE DIFFICULTY GOING AROUND THE TORTUOSITY AND MICROCATHETER KICK BACK. SOME NON-BOSTON SCIENTIFIC LOW-PROFILE PACKING COILS WERE PLACED FOLLOWED BY 4-5MM EMBOLDS FURTHER BACK. FINALLY, A 4MM X 15MM EMBOLD WAS POSITIONED, BUT THERE WAS A DETACHMENT ISSUE. WHEN THE WIRE BETWEEN THE PERFORATION MARKERS WAS SNAPPED, THE PULL WIRE SNAPPED AS WELL. THERE WAS NO PULL WIRE TO GRASP AT ALL. AN ATTEMPT WAS MADE TO REMOVE THE COIL, BUT THE DISTAL END OF THE DELIVERY WIRE WAS KINKED AND WOULD NOT COME BACK ACROSS THE TORTUOUS VESSEL. THE PHYSICIAN ENDED UP CUTTING THE PROXIMAL END OF THE DELIVERY WIRE UNTIL THE PULL WIRE WAS VISIBLE. THE PULL WIRE WAS PULLED, AND THE COIL WAS FINALLY RELEASED, BUT IT WAS SUSPECTED THE PROXIMAL COIL MARKER FROM THE POLYMER SHAFT WAS

  Patient problems: Foreign Body In Patient

  MAUDE report 15417151 ↗
• MalfunctionAug 1, 2022Difficult to Remove; Failure to Advance; Adverse Event Without Identified Device or Use Problem; Difficult to Remove; Failure to Advance; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON ANALYSIS COMPLETED ON (B)(6) 2022. IT WAS REPORTED THAT THE COIL BECAME ENTRAPPED IN THE MICROCATHETER. AN EMBOLD FIBERED 4X15 DETACHABLE COIL SYSTEM WAS SELECTED FOR THE INDEX PROCEDURE. THE .021 RENEGADE MICROCATHETER WAS FLUSHED WITH SALINE DURING PREPARATION AND NO KINKS WERE DETECTED; HOWEVER, WHEN THE COIL WAS ADVANCED HALFWAY THROUGH THE MICROCATHETER, THE COIL WOULD NOT MOVE FORWARD AND IT COULDN'T BE PULLED BACK. THE MICROCATHETER WAS REMOVED FROM THE PATIENT WITH THE COIL STILL IN IT. A NEW MICROCATHETER AND NEW EMBOLD COILS WERE USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED A SEPARATED COIL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15139184 ↗