EMBOLD™ Packing M001394260000600Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00191506026615), received between Jun 6, 2024 and Sep 30, 2026 — classified as 9 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Stretched” (12 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 16 most recent of 16 reports, 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 ↗
• 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 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 ↗
• 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 ↗
• MalfunctionApr 17, 2025Difficult to Remove; Stretched; Failure to Advance; Difficult to Remove; Stretched; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2025. AN EMBOLD PACKING 60 WAS SELECTED FOR USE IN THE GONDAL VEIN. THE PHYSICIAN HAD DEPLOYED A FEW COILS PRIOR TO THE EMBOLD PACKING WITHOUT ISSUE. THE MICROCATHETER, A RENEGADE HI FLO, WAS FLUSHED INTERMITTENTLY AND THE COIL WAS ADVANCED. AFTER ADVANCING TO APPROXIMATELY 30CM FROM THE TIP, RESISTANCE WAS ENCOUNTERED AND THE COIL CEASED TO ADVANCE FURTHER. THE PHYSICIAN ATTEMPTED TO REMOVE THE COIL, AND THE COIL WAS STRETCHED. IMAGING SHOWED A GOOD PORTION OF THE COIL STILL WITHIN THE MICROCATHETER. THE COIL WAS UNABLE TO BE REMOVED FROM THE MICROCATHETER, AND BOTH DEVICES WERE REMOVED FROM THE PATIENT TOGETHER. THE MICROCATHETER AND COIL WERE EXCHANGED, AND THE PROCEDURE WAS COMPLETED WITH NO PATIENT COMPLICATIONS. HOWEVER, DEVICE ANALYSIS REVEALED A PARTIAL COIL DETACHED WITHIN THE MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21861474 ↗
• InjuryApr 7, 2025Break; Difficult to Remove; Stretched; Material Integrity Problem; Break; Difficult to Remove; Stretched; Material Integrity Problem

  IT WAS REPORTED THAT THE COIL BROKE, AND SNARING WAS REQUIRED TO RETRIEVE IT. A 60CM EMBOLD PACKING COIL WAS SELECTED FOR USE IN THE EMBOLIZATION OF A PSEUDOANEURYSM OFF OF THE GASTRODUODENAL ARTERY (GDA) AND ACCESSORY VESSELS WITH LOW TORTUOSITY. INTERMITTENT FLUSHING WAS PERFORMED. THE FIRST 60CM EMBOLD PACKING COIL WAS DEPLOYED SUCCESSFULLY. THIS SECOND 60CM EMBOLD PACKING COIL WAS ADVANCED WITHOUT RESISTANCE AND STARTED TO COIL IN THE VESSEL. HOWEVER, THE MIDDLE PORTION OF THE COIL WOULD NOT PACK TIGHTLY ENOUGH INTO THE VESSEL. IT WAS REPOSITIONED FIVE OR SIX TIMES TO TRY FOR A BETTER PACK, BUT THEN IT STRETCHED OUT. AFTER THE COIL STRETCHED, A SNARE WAS USED TO GRAB THE COIL, BUT WHILE ATTEMPTING TO RETRACT THE COIL, IT BROKE. THE COIL BROKE AT THE STRETCHED PORTION, AND A PORTION OF THE COIL WAS LEFT HANGING OUT OF THE PARENT VESSEL. THIS PORTION OF THE COIL WAS SNARED AND BROKE A FEW TIMES AND THEN SNARED AGAIN. THE PORTION OF THE COIL THAT WAS OUTSIDE OF THE PARENT VESSEL WAS SNARED OUT, AND THE PORTION INSIDE THE TARGET VESSEL WAS LEFT WHERE IT WAS. TWO NEW EMBOLD COILS WERE USED TO FINISH EMBOLIZING THE TARGET VESSEL. THE TARGET VESSEL WAS EMBOLIZED WITHOUT PROBLEM. THERE

  Patient problems: Foreign Body In Patient

  MAUDE report 21791845 ↗
• MalfunctionJan 15, 2025Break; Difficult to Remove; Stretched; Break; Difficult to Remove; Stretched

  IT WAS REPORTED THAT THE COIL BROKE. AN EMBOLD PACKING 60CM COIL WAS SELECTED FOR USE IN A HEMORRHOID EMBOLIZATION PROCEDURE. THE 2-3MM TARGET VESSEL WAS MILDLY TORTUOUS. ONE TO TWO EMBOLD FIBERED COILS WERE DEPLOYED BEFORE ATTEMPTING TO FINISH WITH THIS 60CM PACKING COIL. THE COIL WAS ADVANCED INTO A COLLATERAL VESSEL FEEDING THE HEMORRHOID. THE LAST 5CM DID NOT HAVE ENOUGH ROOM, AND IT WENT INTO A PARENT ARTERY THAT THE INTERVENTIONAL RADIOLOGIST DID NOT WANT TO EMBOLIZE. SINCE THE COIL WAS TOO LONG BY 5CM, THE COIL WAS RETRACTED. 30CM OF THE COIL WAS PULLED OUT WITHOUT ISSUE UNTIL THEY GOT TO A SMALL TURN IN A RECTAL ARTERY, AND THE PACKING COIL GOT CAUGHT ON SOMETHING. THE COIL WOULD NO LONGER RETRACT. THE COIL WAS PULLED HARDER TO GET IT OUT, BUT THE COIL SNAPPED AND DETACHED IN THE MICROCATHETER. THE COIL FILAMENT ENDED UP SNAPPING AFTER THE COIL BECAME STRETCHED FROM THE PULLING/RETRACTION. AN ATTEMPT WAS MADE TO FLUSH THE COIL OUT OF THE MICROCATHETER WITH SALINE; HOWEVER, IT WAS NOTICED THAT COIL FILAMENT WAS STUCK IN THE SHEATH. THE WHOLE DELIVERY SYSTEM (INCLUDING DIAGNOSTIC) HAD TO BE TAKEN OUT TO ENSURE THE WHOLE COIL WAS REMOVED FROM THE PATIENT. UPON REMOVAL OF THE D

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21161812 ↗
• InjuryJun 6, 2024Premature Activation; Difficult to Remove; Stretched; Failure to Advance; Material Protrusion/Extrusion; Premature Activation; Difficult to Remove; Stretched; Failure to Advance; Material Protrusion/Extrusion

  IT WAS REPORTED THAT THE COIL WAS UNABLE TO RETRACT DURING REPOSITIONING AND DETACHED UNEXPECTEDLY. THE EMBOLD PACKING 60 DETACHABLE COIL SYSTEM WAS SELECTED FOR TRIPLE A ENDOLEAK EMBOLIZATION. DURING COILING OF ANEURYSM SAC (ENDOLEAK), THE PHYSICIAN REPOSITIONED THE COIL TO A DIFFERENT PART OF THE ANEURYSM; HOWEVER, IT WOULD NOT MOVE WHILE ATTEMPTING TO PUSH FORWARD. THEY ATTEMPTED TO PULL COIL THROUGH MICROCATHETER WITHOUT SUCCESS, AND THE COIL PREMATURELY DETACHED. THE COIL WAS PARTIALLY DEPLOYED IN THE INTENDED POSITION, BUT A LARGE PART OF THE COIL WAS UNRAVELED AND RETAINED IN THE INFERIOR MESENTERIC ARTERY (OUTSIDE OF THE INTENDED LOCATION), WHERE THEY ATTEMPTED TO REMOVE WITH A SNARE UNSUCCESSFULLY. PROCEDURE WAS NOT ABLE TO BE FINISHED. NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19477103 ↗