EMBOLD PackingRecalls & reported problems across all models

We found 4 models of EMBOLD Packing by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 28 adverse event reports in the FDA's MAUDE database, received between Dec 15, 2023 and Sep 30, 2026 — classified as 15 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Stretched” (18 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported EMBOLD Packing problems

EMBOLD Packing models

4 models, most reported first. Each model has its own page with its reports, recalls and device details.

• EMBOLD™ Packing M001394260000600

  Device, Vascular, for Promoting Embolization
  16 reports
• EMBOLD™ Packing M001394260000450

  Device, Vascular, for Promoting Embolization
  8 reports
• EMBOLD™ Packing M001394260000150

  Device, Vascular, for Promoting Embolization
  3 reports
• EMBOLD™ Packing M001394260000300

  Device, Vascular, for Promoting Embolization
  1 report

Recent EMBOLD Packing adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Break; Difficult to Remove; Failure to Advance; Material Protrusion/Extrusion

  Patient problems: Foreign Body In Patient

  MAUDE report 50949630 ↗
• InjuryAug 4, 2026Break; Adverse Event Without Identified Device or Use Problem

  It was reported that the coil broke within the patient and was unable to be removed. An EMBOLD? Packing 60 coil was used for an embolization. During the procedure, as the coil was being deployed, it broke off in the patient and within the microcatheter. The coil was unable to be pulled out. No further information regarding the patient or procedure outcome was provided despite request by Boston Scientific.

  Patient problems: Foreign Body In Patient

  MAUDE report 50135792 ↗
• MalfunctionJun 1, 2026Premature Activation; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2026. IT WAS REPORTED THAT THE DEVICE PREMATURELY DEPLOYED WITHIN THE PATIENT. AN EMBOLD? PACKING 60 WAS SELECTED FOR USE IN AN EMBOLIZATION PROCEDURE TO TREAT A BLEED. DURING THE PROCEDURE, THE DEVICE PREMATURELY DEPLOYED WITHIN THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. HOWEVER, DEVICE ANALYSIS REVEALED THE COIL WAS SEPARATED FROM THE DISTAL COUPLER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25350637 ↗
• 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 ↗
• MalfunctionApr 7, 2026Premature Activation; Stretched; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON ANALYSIS COMPLETED ON (B)(6) 2026. THE RETURNED DEVICE EVALUATION REVEALED THE COIL WAS DETACHED FROM THE DISTAL COUPLER. THE EMBOLD? PACKING DEVICE WAS USED DURING EMBOLIZATION OF A GASTRODUODENAL ARTERY (GDA) BLEED. AS THE COIL WAS DEPLOYED, THE VESSEL SPASMED AND PUSHED THE MICROCATHETER OUT. WHILE ADVANCING THE COIL, IT DEPLOYED HALFWAY INSIDE THE MICROCATHETER. BOTH THE PACKING COIL AND MICROCATHETER WERE REMOVED, BUT THE COIL BEGAN TO STRETCH OR UNWIND. IT WAS DECIDED TO USE TWO SOFT COILS AND A PACKING COIL FROM ANOTHER MANUFACTURER. NO PATIENT COMPLICATIONS OCCURRED AS A RESULT OF THIS EVENT.

  Patient problems: Vasoconstriction

  MAUDE report 24801146 ↗
• InjuryMar 12, 2026Break; Premature Activation; Stretched; Malposition of Device; Material Integrity Problem

  IT WAS REPORTED THAT THE COIL SNAPPED, AND ADDITIONAL INTERVENTION WAS REQUIRED, RESULTING IN AN UNRETRIEVED DEVICE FRAGMENT (UDF). AN EMBOLD PACKING 60 WAS SELECTED FOR USE TO TREAT A PERSISTENT UPPER GASTROINTESTINAL (GI) BLEED. THE COIL WAS USED IN CONJUNCTION WITH A 1.9F NON-BOSTON SCIENTIFIC MICROCATHETER. THE VESSELS WERE STARTING TO SPASM, SO THE COIL WAS NOT TAKING SHAPE AND PACKING. THE COIL WAS ATTEMPTED TO BE WITHDRAWN INTO THE MICROCATHETER, AT WHICH POINT IT WAS NOTED THAT THE COIL HAD ALREADY DETACHED. THE PROXIMAL RELEASE PERFORATION HAD NOT BEEN BROKEN. THE TAIL OF THE COIL WAS OBSERVED AND HAD TO BE SNARED OUT OF THE AORTA. APPROXIMATELY 15CM OF THE COIL WAS LEFT BEHIND IN THE SECOND ORDER BRANCH OFF THE SUPERIOR MESENTERIC ARTERY (SMA). THE PHYSICIAN LATER EXPLAINED HE FELT A "POP" WHEN TRYING TO WITHDRAW THE COIL INTO THE MICROCATHETER. THE BOSTON SCIENTIFIC REPRESENTATIVE PRESUMED THAT THE COUPLERS MOST LIKELY WERE STILL ATTACHED AND THE COIL INSTEAD HAD SNAPPED AND STRETCHED MORE PROXIMAL TO THE COUPLERS. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: Foreign Body In Patient; Vasoconstriction

  MAUDE report 24582513 ↗
• MalfunctionDec 19, 2025Break; Difficult to Remove; Stretched; Break; Difficult to Remove; Stretched

  IT WAS REPORTED THAT THE COIL WAS BROKEN. THIS EMBOLD PACKING 60 DEVICE WAS SELECTED FOR USE DURING THIS COILING PROCEDURE. THE TARGET VESSEL WAS NOTED TO BE MODERATELY TO SEVERELY TORTUOUS, NOT CALCIFIED, AND NOT STENOSED. DURING THE PROCEDURE, UPON ATTEMPTING TO RETRACT THE PACKING EMBOLD COIL, IT CAME APART WITHIN THE CATHETER, LEAVING THE FILAMENT HANGING FROM THE DISTAL PORTION OF THE CATHETER. IT WAS SUCCESSFULLY RETRIEVED WITH THE CATHETER. IT APPEARED TO HAVE BROKEN APART OR STRETCHED, AS IT MAY HAVE BECOME STUCK OR CAUGHT UP WITHIN THE ANEURYSM. A PORTION OF THE DEVICE WAS REMOVED, AND A PORTION REMAINED IMPLANTED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THE EVENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 23854181 ↗
• InjuryDec 3, 2025Break; Stretched; Difficult to Advance; Break; Stretched; Difficult to Advance

  IT WAS REPORTED THAT THE COIL BROKE REQUIRING ADDITIONAL INTERVENTION. AN EMBOLD PACKING COIL WAS SELECTED FOR USE IN A CELIAC BLEED EMBOLIZATION PROCEDURE. DURING PLACEMENT OF THE COIL INTO THE 3-4MM VESSEL, RESISTANCE WAS FELT. THE COIL WAS PULLED BACK; HOWEVER, THE COIL STRETCHED AND SNAPPED IN THE VESSEL. A SNARE WAS USED TO REMOVE SOME OF THE COIL. THE PATIENT WAS HOSPITALIZED BEYOND STANDARD OF CARE, AND ANOTHER CASE WAS SCHEDULED TO RETRIEVE/SNARE THE REMAINING PORTION OF THE COIL FROM THE AORTA. THE ISSUE IS ONGOING.

  Patient problems: Foreign Body In Patient

  MAUDE report 23709694 ↗
• InjuryDec 2, 2025Stretched; Stretched

  IT WAS REPORTED THAT THE COIL STRETCHED AND WAS REMOVED WITH A SNARE. A 60CM EMBOLD? PACKING WAS SELECTED AS THE LAST COIL IN AN EMBOLIZATION PROCEDURE. THE TARGET VESSEL WAS A SACCULAR ANEURYSM, AND THE ANATOMY WAS MODERATELY TORTUOUS. INTERMITTENT FLUSHING WAS PERFORMED. DURING THE PROCEDURE, THE COIL BECAME STRETCHED INSIDE THE VASCULATURE. THE PHYSICIAN DESCRIBED THE FAILURE FEELING LIKE MORE OF A "POP" THAN RESISTANCE. THE COIL WAS REMOVED VIA A SNARE, AND THE PROCEDURE WAS COMPLETED. THE PHYSICIAN STATED THAT THIS LAST COIL DIDN'T NECESSARILY NEED TO BE PLACED AND PROBABLY SHOULD HAVE STOPPED AT THE PREVIOUS COIL. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23698197 ↗
• 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 ↗
• InjurySep 30, 2025Break; Difficult to Remove; Stretched; Difficult to Advance; Material Protrusion/Extrusion; Break; Difficult to Remove; Stretched; Difficult to Advance; Material Protrusion/Extrusion

  IT WAS REPORTED THAT THE COIL WAS PROTRUDING OUTSIDE THE TARGET LOCATION, REQUIRING INTERVENTION. THIS EMBOLD PACKING COIL WAS SELECTED FOR USE DURING A SPLENIC ARTERY EMBOLIZATION PROCEDURE. THE TARGET VESSEL HAD MODERATE TORTUOSITY. DURING THE PROCEDURE, THE EMBOLD PACKING COIL WAS DIFFICULT TO ADVANCE. THE COIL WAS THEN DEPLOYED, AND THE PHYSICIAN ATTEMPTED TO RETRIEVE THE COIL IN ORDER TO REPOSITION IT; HOWEVER, INCREASED RESISTANCE WAS FELT UPON RETRIEVAL. THE COIL BECAME STRETCHED AND BROKEN AS A RESULT. THE PUSHER WIRE WAS REMOVED LEAVING THE COIL OUTSIDE THE TARGET VESSEL. A SECOND COIL WAS SUCCESSFULLY PLACED. THE PROCEDURE WAS PROLONGED. THE PATIENT WAS STABLE POST PROCEDURE, AND AN ADDITIONAL SURGERY WAS SCHEDULED TO REMOVE THE COIL. THERE WERE NO OTHER PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23183217 ↗
• MalfunctionAug 26, 2025Break; Difficult to Remove; Failure to Advance; Break; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE COIL BROKE. A 60CM EMBOLD? PACKING COIL WAS SELECTED FOR USE IN THE EMBOLIZATION OF A HEPATIC BLEED. THE VESSEL WAS MODERATELY TORTUOUS. DURING THE PROCEDURE, THE COIL WAS UNABLE TO ADVANCE THROUGH THE MICROCATHETER. THE COIL MADE IT TO THE MIDDLE/DISTAL PORTION OF THE MICROCATHETER BEFORE IT COULD NOT ADVANCE ANY FURTHER. THERE WAS RESISTANCE DURING ADVANCEMENT AND RETRACTION, AND THE COIL BROKE INSIDE THE MICROCATHETER. THE COIL BROKE OFF FROM THE DISTAL COUPLER. THE COIL WAS REMOVED TOGETHER WITH THE MICROCATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER EMBOLD? COIL OF THE SAME SIZE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT TWO MICROCATHETERS WERE USED IN THIS CASE, BUT IT COULD NOT BE CONFIRMED WHICH ONE ENCOUNTERED THE ISSUE: A 2.4F NON-BOSTON SCIENTIFIC MICROCATHETER AND A TRUSELECT MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22893615 ↗
• InjuryAug 5, 2025Difficult to Remove; Stretched; Failure to Advance; Difficult to Remove; Stretched; Failure to Advance

  IT WAS REPORTED THAT THE COIL BECAME STUCK AND STRETCHED, REQUIRING A SNARE FOR REMOVAL. AN EMBOLD PACKING 60 WAS SELECTED FOR USE IN A SPLENIC EMBOLIZATION PROCEDURE. WHEN THE COIL WAS BEING DEPLOYED INTO THE COIL PACK, THE COIL BECAME STUCK AND STRETCHED. IT KEPT UNRAVELING TO WHERE THE PHYSICIAN COULD SEE FILAMENT. THE COIL WAS ACCESSED WITH A BIG SNARE TO SNARE IT OUT, AND THE PROCEDURE WAS COMPLETED USING AN ALTERNATE METHOD. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22723131 ↗
• InjuryJun 26, 2025Premature Activation; Difficult to Remove; Stretched; Malposition of Device; Premature Activation; Difficult to Remove; Stretched; Malposition of Device

  IT WAS REPORTED THAT THE COIL MALPOSITIONED, REQUIRING VASCULAR SURGERY FOR COIL RETRIEVAL. AN EMBOLD PACKING 60 WAS SELECTED FOR AN EMBOLIZATION PROCEDURE. DURING THE PROCEDURE, THE COIL STRETCHED. WHILE ATTEMPTING TO PULL THE COIL BACK THROUGH THE MICROCATHETER, THERE WAS RESISTANCE DURING RETRACTION, AND THE COIL DETACHED, RESULTING IN DEPLOYMENT OUTSIDE OF THE TARGET LOCATION. THE PROCEDURE WAS DISCONTINUED, AND THE PATIENT WAS REFERRED TO A VASCULAR SURGERY TO RETRIEVE THE MISPOSITIONED COIL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22342161 ↗
• InjuryJun 23, 2025Premature Activation; Stretched; Material Protrusion/Extrusion; Premature Activation; Stretched; Material Protrusion/Extrusion

  IT WAS REPORTED THAT THE COIL STRETCHED AND PROTRUDED FROM THE TARGET LESION, AND NEEDED TO BE SNARED FROM THE VASCULATURE. AN EMBOLD PACKING WAS SELECTED FOR USE IN THE RENAL EMBOLIZATION PROCEDURE. THE COIL WAS ADVANCED TO THE TARGET LESION WITHOUT RESISTANCE. WHEN THE COIL WAS RETRACTED, THE COIL STRETCHED AND DEPLOYED PREMATURELY, PROTRUDING FROM THE TARGET VESSEL INTO THE AORTA. A SNARE WAS USED TO REMOVE THE COIL FROM THE PATIENT. AN ADDITIONAL EMBOLD COIL WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22310505 ↗

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