EMBOLD™ Packing M001394260000450Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00191506026608), received between Nov 15, 2024 and May 5, 2026 — classified as 4 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Break” (6 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.

• MalfunctionMay 5, 2026Break

  IT WAS REPORTED THAT A BREAK OCCURRED. AN 45CM EMBOLD PACKING WAS SELECTED FOR USE. DURING THE PROCEDURE, THE COIL PARTS WERE BROKEN/SEPARATED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25084756 ↗
• InjuryJun 11, 2025Break; Difficult to Remove; Stretched; Positioning Problem; Break; Difficult to Remove; Stretched; Positioning Problem

  IT WAS REPORTED THAT THE CATHETER KICKED-BACK UPON COIL PACKING, AND THE COIL BROKE UPON REMOVAL. THIS PATIENT WAS RECEIVING EMBOLIZATION TREATMENT FOR BLEEDING IN THE GASTRIC ARTERY. DURING THE PROCEDURE, A 3 MM EMBOLD FIBERED COIL DELIVERED THEN THE REST WAS FILLED IN WITH THIS 45CM EMBOLD PACKING COIL. THE COIL WAS ADVANCED EASILY INTO THE ARTERY, BUT DURING PACKING, THE COIL PUSHED THE MICROCATHETER OUT OF THE VESSEL. THE COIL WAS ATTEMPTED TO BE RETRACTED, BUT THE COIL UNRAVELED/STRETCHED AND WAS UNABLE TO BE PULLED ALL THE WAY BACK INTO THE MICROCATHETER AND EVENTUALLY BROKE. THE COIL WAS PARTIALLY EXPLANTED, AND A PORTION STILL REMAINS INSIDE THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION INDICATED THAT A SNARE WAS ATTEMPTED TO BE USED TO REMOVE THE PORTION THAT REMAINED INSIDE THE PATIENT, AND IT ENDED UP PUSHING COIL INTO PARENT VESSEL.

  Patient problems: Foreign Body In Patient

  MAUDE report 22188713 ↗
• InjuryJun 5, 2025Break; Difficult to Remove; Stretched; Break; Difficult to Remove; Stretched

  IT WAS REPORTED THAT THE COIL BROKE AND WAS DIFFICULT TO REMOVE, REQUIRING AN ADDITIONAL DEVICE. THIS EMBOLD PACKING 45 WAS SELECTED FOR USE DURING AN EPIGASTRIC EMBOLIZATION PROCEDURE IN MILDLY TORTUOUS ANATOMY. DURING THE PROCEDURE WHEN THIS EMBOLD PACKING COIL WAS BEING ADVANCED, THE PUSHER WIRE DETACHED, AND THE INTERNAL WIRE STAYED ATTACHED TO THE COUPLERS. AN ATTEMPT WAS MADE TO REMOVE THE ENTIRE SYSTEM; HOWEVER, ONLY THE DELIVERY WIRE CAME OUT WITH BOTH COUPLERS REMAINING ON THE DELIVERY WIRE. A SNARE WAS USED TO PULL OUT THE COIL WHICH EXPERIENCED STRETCHING AND BREAKING IN SEVERAL AREAS. THREE DIFFERENT SNARES WERE USED TO EXTRACT THE COIL, AND THE PROCEDURE WAS COMPLETED USING PUSHABLE COILS. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THIS DID NOT OCCUR DURING AN ATTEMPT TO DEPLOY THE COILS, AS THE PROXIMAL RELEASE PERFORATION WAS NOT BROKEN. THERE WAS A DETACHMENT AT THE COUPLERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22155100 ↗
• InjuryMay 21, 2025Stretched; Material Protrusion/Extrusion; Stretched; Material Protrusion/Extrusion

  IT WAS REPORTED VIA THAT THE COIL WAS STRETCHED AND PROTRUDING FROM THE TARGET LOCATION, REQUIRING EXPLANTATION. A 45CM EMBOLD PACKING COIL WAS SELECTED FOR USE IN AN EMBOLIZATION PROCEDURE IN THE 4MM GASTRODUODENAL ARTERY (GDA). A 4MM FIBERED COIL WAS PLACED DISTALLY PRIOR TO THE PLACEMENT OF THIS COIL. THIS EMBOLD PACKING COIL WAS PLACED IN THE GDA WITHOUT INCIDENT. HOWEVER, UPON FOLLOW UP USING CT, THE COIL WAS FOUND TO BE STRETCHED AND EXTENDING OUT OF THE TARGET VESSEL INTO THE ORIGIN OF THE CELIAC ARTERY INTO THE PROXIMAL AORTA AND THEN DESCENDING TO THE RIGHT COMMON FEMORAL ARTERY. THE COIL WAS SCHEDULED TO BE EXPLANTED ON (B)(6) 2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22066771 ↗
• InjuryMar 27, 2025Break; Stretched; Difficult to Advance; Break; Stretched; Difficult to Advance

  IT WAS REPORTED THAT THE COIL BROKE AND REQUIRED A SNARE FOR RETRIEVAL. AN EMBOLD PACKING 45 WAS SELECTED FOR A HYPO EMBOLIZATION PROCEDURE IN THE MILDLY TORTUOUS INTERNAL ILIAC ARTERY. WHILE ADVANCING THE COIL USING INTERMITTENT FLUSHING, IT BECAME DIFFICULT TO PUSH FROM THE DISTAL PART OF THE 2.4 FRENCH NON-BOSTON SCIENTIFIC MICROCATHETER. IT WAS ATTEMPTED TO RETRACT THE COIL, BUT THE COIL STRETCHED TO THE POINT OF BREAKING. THE COIL BROKE OFF WITH A PORTION IN THE CATHETER AND A PORTION IN THE COIL NEST. THE MICROCATHETER WAS REMOVED WITH ONE FRACTURED PORTION OF THE COIL INSIDE, AND THE FRACTURED PORTION IN THE COIL NEST WAS REMOVED WITH A SNARE. NO COIL WAS LEFT IN THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21713059 ↗
• MalfunctionFeb 5, 2025Difficult to Insert; Device-Device Incompatibility; Material Deformation; Difficult to Insert; Device-Device Incompatibility; Material Deformation

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 10JAN2025. AN EMBOLD PACKING 45 COIL WAS SELECTED FOR USE. THE PHYSICIAN HAD DELIVERED A COMBINATION OF EMBOLD FIBERED, SOFT, AND PACKING COILS VIA A NON-BOSTON SCIENTIFIC MICROCATHETER WITHOUT DIFFICULTY. THERE WAS A DIFFICULT BRANCH TO ENGAGE WITH THE FIRST MICROCATHETER, SO THE DEVICE WAS EXCHANGED FOR A SHORTER NON-BOSTON SCIENTIFIC MICROCATHETER. ONCE THE VESSEL WAS ENGAGED, THE PHYSICIAN WANTED TO DEPLOY AN EMBOLD PACKING COIL. THE PHYSICIAN MET RESISTANCE WHEN TRYING TO ADVANCE THE COIL INTO THE MICROCATHETER AND NOTICED THE DISTAL TIP OF THE COIL WAS KINKED. THE COIL WAS REMOVED AND NOT IMPLANTED. THE PHYSICIAN ASKED FOR A SECOND EMBOLD PACKING COIL AND HAD SOME DIFFICULTY ADVANCING AGAIN BUT WAS ABLE TO GET THE COIL WITHIN THE MICROCATHETER. HOWEVER, WITH THE INCREASED RESISTANCE WITH ADVANCING THE COIL, THE PHYSICIAN DECIDED TO REMOVE THE SECOND COIL. UPON RETRACTING THE COIL, THE COIL BEGAN TO STRETCH. THE ENTIRE COIL WAS REMOVED FROM THE MICROCATHETER. AT THIS POINT, THE PHYSICIAN DECIDED TO STOP THE CASE AND REEVALUATE THE IMAGES. THE PHYSICIAN THEN REALIZED WHAT WAS NEEDED TO BE DONE WAS ACCOMPLISHED AND THE PROCEDURE W

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21314904 ↗
• MalfunctionDec 6, 2024Break; Difficult to Remove; Failure to Advance; Break; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT A COIL BREAK OCCURRED. AN EMBOLD PACKING COIL WAS SELECTED FOR USE IN A BILATERAL RENAL ARTERY EMBOLIZATION PROCEDURE. THE VESSEL WAS MILDLY TORTUOUS. AFTER IMPLANTING A FIBERED COIL WITH NO ISSUE, THE EMBOLD PACKING COIL WAS DELIVERED WITH A PULSATION METHOD. IT WAS NOTED THAT THE COIL WAS NOT ADVANCING AND THE COIL BECAME DETACHED INTO TWO PIECES. DURING AN ATTEMPT TO PULL THE COIL BACK, IT MAINTAINED INSIDE THE 2.4 FRENCH NON-BOSTON SCIENTIFIC MICROCATHETER. SEVERAL WIRES WERE USED TO PUSH THE COIL FORWARD AND A WIRE WAS PLACED ALONG SIDE OF THE COIL AND ANCHORED IT AGAINST THE MICRO CATHETER. EVERYTHING WAS ABLE TO BE RETRIEVED. THE PROCEDURE WAS COMPLETED WITH ANOTHER BASE AND MICRO CATHETER. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20866255 ↗
• MalfunctionNov 15, 2024Break; Separation Failure; Break; Separation Failure

  IT WAS REPORTED THAT A COIL BREAK OCCURRED. AN EMBOLD PACKING 45 WAS SELECTED FOR AN EMBOLIZATION PROCEDURE IN THE PORTAL VEIN. DURING THE PROCEDURE, THE COIL DID NOT DETACH CORRECTLY AND BROKE OFF IN THE CATHETER. THE COIL WAS REMOVED FROM THE CATHETER. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20694685 ↗