EMBOLD™ Packing M001394260000150Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00191506026585), received between Dec 15, 2023 and Nov 17, 2025 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Premature Activation” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 17, 2025Break; Entrapment of Device; Premature Activation; Break; Entrapment of Device; Premature Activation

  IT WAS REPORTED PER MEDWATCH (B)(4) THAT THE COIL BROKE AND THE FILAMENT REMAINED IN THE MICROCATHETER. AN EMBOLD PACKING 15 WAS SELECTED FOR AN ARTERY EMBOLIZATION PROCEDURE. WHEN ADVANCING THE DELIVERY WIRE THROUGH THE MICROCATHETER, HOWEVER, THE COIL DETACHED WITHOUT USING THE DEPLOYMENT MECHANISM. WHEN THE MICROCATHETER WAS REMOVED, PART OF THE COIL FILAMENT WAS STILL IN THE LUMEN OF THE MICROCATHETER. TWO SUBSEQUENT ARTERIES WERE SELECTED AND EMBOLIZED THEN UPON ATTEMPTED REMOVAL OF BASE CATHETER, THE WIRE WAS UNABLE TO BE ADVANCED PAST THE TIP OF THE BASE CATHETER, AND WHEN REMOVING THE CATHETER, THE COIL FILAMENT WAS OBSERVED TO BE PROTRUDING FROM THE TIP OF THE CATHETER. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23571122 ↗
• InjuryMay 14, 2025Stretched; Stretched

  IT WAS REPORTED THAT THE COIL STRETCHED, AND A SNARE WAS USED TO PUSH THE COIL INTO THE LESION. A LONG SHEATH WAS ADVANCED THROUGH THE INTERNAL ILIAC ARTERY, AND THROUGH THE SHEATH A 5 FRENCH BASE CATHETER WAS ADVANCED. A .021 DIREXION BERN MICROCATHETER WAS THEN ADVANCED INTO THE NON-CALCIFIED AND MILDLY TORTUOUS PROSTATE ARTERY TARGET LESION. THE PHYSICIAN EMBOLIZED THAT ARTERY AND WANTED TO COIL ON EXIT. A FEW NON-BOSTON SCIENTIFIC COILS WERE DEPLOYED, THEN THE EMBOLD PACKING 15CM WAS SELECTED. THE COIL WAS PREPPED AND ADVANCED IN THE NORMAL FASHION WITHOUT DIFFICULTY. AS THE COIL WAS EXITING THE MICROCATHETER, HOWEVER, IT WAS NOTED TO LOOK IRREGULAR ON FLUOROSCOPY. WHILE ATTEMPTING TO REMOVE THE COIL, IT WAS STRETCHING. THE PHYSICIAN ADVANCED A SNARE TO REMOVE THE COIL, BUT ULTIMATELY THE SNARE ENDED UP DETACHING THE COIL AND WAS ABLE TO PUSH THE COIL INTO THE PROSTATE ARTERY. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22022207 ↗
• MalfunctionDec 15, 2023Premature Activation; Difficult to Remove; Material Protrusion/Extrusion; Premature Activation; Difficult to Remove; Material Protrusion/Extrusion

  IT WAS REPORTED THAT THE COIL WAS PROTRUDING FROM THE TARGET ANEURYSM. AN EMBOLD PACKING DETACHABLE COIL SYSTEM WAS SELECTED FOR USE TO TREAT AN ANEURYSM IN THE SMALL, TORTUOUS SPLENIC ARTERY. PRIOR TO THE PACKING COIL BEING DEPLOYED, THE PHYSICIAN HAD PREVIOUSLY DEPLOYED TWO FRAMING COILS AND THE FIRST PACKING COIL. THE PACKING COIL WAS ADVANCED TO THE ANEURYSM AND DEPLOYED BY APPROXIMATELY 50% WHEN THE PHYSICIAN REALIZED THE SECOND PACKING COIL WOULD BE TOO MUCH. THE PACKING COIL WAS RETRACTED, AT WHICH POINT RESISTANCE WAS ENCOUNTERED AND THE PACKING COIL UNINTENTIONALLY DEPLOYED. A PORTION OF THE PACKING COIL EXTENDED INTO THE SPLENIC ARTERY. NO CORRECTIVE ACTION WAS TAKEN AS A RESULT OF THE PROTRUDING COIL, AND THERE WERE NO REPORTED PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18340750 ↗