EMBOLD FiberedRecalls & reported problems across all models
Boston Scientific Corporation · 23 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 140
- Deaths reported
- 0
- Injuries reported
- 67
- Recalls
- 0
We found 23 models of EMBOLD Fibered by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 140 adverse event reports in the FDA's MAUDE database, received between Jun 24, 2022 and Sep 24, 2026 — classified as 67 injuries, 73 malfunctions.
The most frequently reported specific device problem is “Stretched” (74 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
Reports received per month, all models
Most reported EMBOLD Fibered problems
Device problems
- Stretched74
- Break61
- Difficult to Remove54
- Premature Activation32
- Material Protrusion/Extrusion31
- Difficult to Advance27
- Adverse Event Without Identified Device or Use Problem23
- Failure to Advance21
Patient problems
- No Clinical Signs, Symptoms or Conditions102
- Foreign Body In Patient35
- Vascular Dissection3
- Vasoconstriction3
- Embolism/Embolus2
- Thrombosis/Thrombus2
- Muscle Weakness/Atrophy1
- Nausea1
EMBOLD Fibered models
23 models, most reported first. Each model has its own page with its reports, recalls and device details.
- EMBOLD™ Fibered M001394240020040Device, Vascular, for Promoting Embolization18 reports
- EMBOLD™ Fibered M001394240020060Device, Vascular, for Promoting Embolization17 reports
- EMBOLD™ Fibered M001394240030120Device, Vascular, for Promoting Embolization12 reports
- EMBOLD™ Fibered M001394240060200Device, Vascular, for Promoting Embolization11 reports
- EMBOLD™ Fibered M001394240100500Device, Vascular, for Promoting Embolization11 reports
- EMBOLD™ Fibered M001394240050150Device, Vascular, for Promoting Embolization9 reports
- EMBOLD™ Fibered M001394240040150Device, Vascular, for Promoting Embolization8 reports
- EMBOLD™ Fibered M001394240080200Device, Vascular, for Promoting Embolization8 reports
- EMBOLD™ Fibered M001394240030060Device, Vascular, for Promoting Embolization6 reports
- EMBOLD™ Fibered M001394240040080Device, Vascular, for Promoting Embolization5 reports
- EMBOLD™ Fibered M001394240180500Device, Vascular, for Promoting Embolization5 reports
- EMBOLD™ Fibered M001394240140300Device, Vascular, for Promoting Embolization4 reports
- EMBOLD™ Fibered M001394240220600Device, Vascular, for Promoting Embolization4 reports
- EMBOLD™ Fibered M001394240320600Device, Vascular, for Promoting Embolization3 reports
- EMBOLD™ Fibered M001394240100200Device, Vascular, for Promoting Embolization3 reports
- EMBOLD™ Fibered M001394240140500Device, Vascular, for Promoting Embolization3 reports
- EMBOLD™ Fibered M001394240200500Device, Vascular, for Promoting Embolization3 reports
- EMBOLD™ Fibered M001394240100300Device, Vascular, for Promoting Embolization2 reports
- EMBOLD™ Fibered M001394240120200Device, Vascular, for Promoting Embolization2 reports
- EMBOLD™ Fibered M001394240120300Device, Vascular, for Promoting Embolization2 reports
- EMBOLD™ Fibered M001394240120500Device, Vascular, for Promoting Embolization2 reports
- EMBOLD™ Fibered M001394240050080Device, Vascular, for Promoting Embolization1 report
- EMBOLD™ Fibered M001394240060100Device, Vascular, for Promoting Embolization1 report
Recent EMBOLD Fibered adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 24, 2026Device-Device Incompatibility; Material Protrusion/Extrusion
It was reported that the previously deployed coil was pulled out of position, and intervention was required to correct its position.Two 20mm x 50cm EMBOLD? Fibered coils were selected for use in the embolization of a splenic artery aneurysm. Other non-Boston Scientific coils were also used in the procedure. The microcatheter was flushed immediately prior to coil insertion, and continuous flushing was performed throughout the procedure. During the procedure, resistance was felt during coil placement. An attempt was made to retrieve the coil; however, the coil became unraveled, making retrieval impossible. An attempt was made to withdraw the coil together with the microcatheter; however, the previously deployed coil, another 20mm x 50cm EMBOLD. Fibered coil, also moved. It might have been the coil that caught on the previously deployed coil. As a result, retrieval was unsuccessful. The unraveled coil was secured with a balloon and cut outside the body. The cut end was pushed into the aneurysm using another coil, resulting in a portion of the coil remaining in the body. The previously deployed coil moved out of position, partially in the target vessel and partially protruding out of t
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50889517 ↗InjurySep 3, 2026Premature Activation; Stretched; Material Protrusion/Extrusion
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50599520 ↗MalfunctionSep 2, 2026Break; Difficult to Remove; Difficult to Advance
Patient problems: Foreign Body In Patient
MAUDE report 50569942 ↗MalfunctionSep 1, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50551531 ↗InjurySep 1, 2026Entrapment of Device; Difficult to Remove; Stretched
It was reported that the coil stretched, requiring additional intervention.An EMBOLD¿ Fibered 12x20 device was selected to treat variceal bleeding in the portal branches. The target lesion was reported as moderately tortuous. The coil was successfully placed in the target vessel proximal to several other Embold Fibered Coils and non-Boston Scientific packing coils. After breaking the proximal release perforation, the physician proceeded to withdraw the pull wire. Under fluoroscopy, the physician noted that the coil appeared to be withdrawing along with the pull wire. The physician noted that the pull wire appeared to be stuck to the catheter tip and reported resistance when attempting to withdraw. A snare was used to remove the pull wire. The coil was noted to be stretched within the vessel. Several other coils were then successfully deployed proximal to the stretched coil. There were no patient consequences as a result of this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50547920 ↗InjuryAug 27, 2026Difficult to Remove; Stretched; Failure to Advance; Device-Device Incompatibility
It was reported that the stretched coil required intervention to retrieve, but there were unretrieved device fragments.A 20mm x 50cm EMBOLD Fibered coil was selected for use in the embolization of a splenic artery aneurysm. During the procedure, resistance was felt during coil placement. An attempt was made to retrieve the coil; however, the coil became unraveled, making retrieval impossible. An attempt was made to withdraw the coil together with the microcatheter; however, a previously deployed coil also moved. As a result, retrieval was unsuccessful. The unraveled coil was secured with a balloon and cut outside the body. The cut end was pushed into the aneurysm using another coil, resulting in a portion of the coil remaining in the body. There were no patient complications as a result of this event.
Patient problems: Foreign Body In Patient
MAUDE report 50478241 ↗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 ↗InjuryAug 3, 2026Stretched; Device-Device Incompatibility; Material Protrusion/Extrusion
It was reported that the coil stretched out of the target location.A 10mm x 50cm EMBOLD? Fibered coil was selected for use in an embolization procedure of the non-tortuous left ovarian vein. The target vessel diameter was 6-7 mm. The patient was being treated for pelvic congestion. The distal left ovarian vein was embolized with two EMBOLD? Fibered coils successfully. Afterwards, the proximal ovarian vein was embolized with two EMBOLD? Fibered coils. It appeared normal and the whole delivery system and microcatheter were pulled out of the ovarian vein; however, in doing so, the second to last coil became entangled with either the microcatheter or the 5Fr catheter, resulting in the coil unraveling with a strand stretched out. A fine strand of the coil extended all the way back into the sheath through the inferior vena cava (IVC). During removal of the microcatheter, tension on this strand pulled the proximal portion of the coil up into the renal vein. The team was able to reposition the proximal portion of the coil back into the ovarian vein; however, despite several hours of effort, using various guidewires and snares, they were unable to retrieve the remaining strand that extended
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50116340 ↗InjuryJul 31, 2026Stretched
It was reported that the coil stretched within the patient, resulting in additional intervention.An EMBOLD? Fibered 10x50 was selected for use for a splenic artery embolization. The Embold coil was deployed but was noted to stretch due to the non-Boston Scientific catheter kinking. The stretched coil was successfully retrieved and fully explanted using a snare. The procedure was successfully completed using an alternate coil. There were no patient complications as a result of this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50100696 ↗MalfunctionJul 7, 2026Premature Activation; Difficult to Advance
REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 08JUN2026. IT WAS REPORTED THAT PREMATURE DEPLOYMENT OCCURRED. A 10X20 EMBOLD FIBERED WAS SELECTED FOR AN EMBOLIZATION PROCEDURE. THE COIL WAS DIFFICULT TO ADVANCE AND DEPLOYED IN THE CATHETER BEFORE 25 PERCENT OF THE COIL WAS DEPLOYED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. AN ALTERNATE DEVICE WAS USED TO COMPLETE THE PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED COIL SEPARATION FROM THE DISTAL COUPLER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25738424 ↗MalfunctionJun 11, 2026Break
IT WAS REPORTED THAT A BREAK OCCURRED. A 2X6 EMBOLD FIBERED WAS SELECTED FOR USE. DURING THE PROCEDURE, OTHER COILS WERE DEPLOYED PRIOR TO THE 2X6 EMBOLD FIBERED COIL. A PORTION OF THE 2X6 EMBOLD FIBERED SHAFT WAS DAMAGED AND BROKE OFF ALONGSIDE THE COIL. THE DEVICE WAS REMOVED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25472305 ↗InjuryJun 1, 2026Break; Difficult to Remove; Malposition of Device
IT WAS REPORTED THAT THE COIL FRACTURED, RESULTING IN AN UNRETRIEVED DEVICE FRAGMENT. AN EMBOLD? FIBERED 6X20 WAS SELECTED FOR USE TO TREAT AN ABDOMINAL AORTIC ANEURYSM ALONG WITH A TRUSELECT MICROCATHETER. PRIOR TO USE OF THE EMBOLD DEVICE, A NON-BOSTON SCIENTIFIC LIQUID EMBOLIC AGENT WAS USED TO TREAT THE LESION. THE TARGET VESSEL WAS REPORTED TO BE TORTUOUS. DURING THE PROCEDURE, WHILE POSITIONING AND DEPLOYING THE COIL IN THE PROXIMAL INFERIOR MESENTERIC ARTERY, THERE WAS RESISTANCE ENCOUNTERED IN THE COIL DETACHMENT SYSTEM. AS A RESULT, THE COIL FRACTURED, WITH A FRAGMENT OF THE COIL BREAKING OFF WITHIN THE PATIENT. SEVERAL ATTEMPTS WERE MADE TO RETRIEVE THE COIL FRAGMENT USING AN UNKNOWN 4MM MICRO-SNARE, BUT ATTEMPTS WERE UNSUCCESSFUL. THE PHYSICIAN WAS UNABLE TO RETRIEVE THE COIL FRAGMENT, WHICH WAS OBSERVED PROXIMALLY AT THE LEVEL OF THE LEFT COLIC ARTERY, OUTSIDE OF THE TARGET LESION. NO FURTHER INTERVENTION WAS REPORTED.
Patient problems: Foreign Body In Patient
MAUDE report 25350626 ↗MalfunctionJun 1, 2026Premature Activation; Difficult to Remove; Stretched; Adverse Event Without Identified Device or Use Problem
REPORTABLE BASED ON PRODUCT ANALYSIS ON (B)(6) 2026. AN EMBOLD? FIBERED WAS SELECTED FOR USE TO TREAT A SPLENIC ARTERY ANEURYSM. DURING COIL POSITIONING, THE PHYSICIAN ATTEMPTED TO RECAPTURE THE COIL, BUT THERE WAS RESISTANCE ENCOUNTERED, AND THE COIL BEGAN TO FRAY. THE COIL PREMATURELY DEPLOYED WITHIN THE MICROCATHETER. THE COIL WAS REMOVED TOGETHER WITH THE MICROCATHETER. THE COIL WAS REPLACED WITH ANOTHER OF THE SAME DEVICE AND THE CASE WAS SUCCESSFULLY COMPLETED WITH NO PATIENT COMPLICATIONS. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED THAT THE MAIN COIL WAS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25349953 ↗MalfunctionMay 27, 2026Stretched; Separation Failure; Adverse Event Without Identified Device or Use Problem
REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2026. IT WAS REPORTED THAT THE COIL COULD NOT BE DETACHED AND UNRAVELED. AN 12X50 EMBOLD? FIBERED WAS SELECTED FOR USE IN A BALLOON-OCCLUDED RETROGRADE TRANSVENOUS OBLITERATION (BRTO) PROCEDURE IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED GASTRIC VEIN. DURING THE PROCEDURE, THE COIL DID NOT DETACH, DESPITE BENDING AND PULLING THE DETACHMENT MARKER PART BEYOND THE PROXIMAL MARKER. THE COIL UNRAVELED. THE COIL AND THE PUSHER WERE COMPLETELY RETRIEVED FROM THE PATIENT. ANOTHER OF THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. HOWEVER, DEVICE ANALYSIS REVEALED COIL SEPARATION FROM THE DISTAL COUPLER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25305892 ↗InjuryMay 20, 2026Difficult to Remove; Stretched; Material Protrusion/Extrusion; Migration
IT WAS REPORTED THAT THE COIL MIGRATED AND REQUIRED ADDITIONAL INTERVENTION. AN EMBOLD? FIBERED 6X20 WAS SELECTED FOR USE TO TREAT A SPLENIC LACERATION. THE EMBOLD COIL WAS SUCCESSFULLY DEPLOYED INTO THE PROXIMAL SPLENIC ARTERY. STASIS WAS NOT ACHIEVED, SO THE PHYSICIAN FOLLOWED IT WITH A 45 CM NON-BOSTON SCIENTIFIC (BSC) PACKING COIL. BEFORE THEY FULLY DEPLOYED THE NON-BSC COIL, THE EMBOLD SHOT DISTALLY INTO THE SPLEEN. THE PHYSICIAN RESHEATHED THE NON-BSC PACKING AND SENT A SNARE TO RETRIEVE THE EMBOLD. THE PHYSICIAN WAS ABLE TO GRAB HOLD OF THE EMBOLD AND PULL IT BACK ALL THE WAY TO THE ORIGIN OF THE SPLENIC ARTERY, BUT WAS UNABLE TO RETRACT IT INTO THE MICROCATHETER. THE PHYSICIAN REPORTED SOME RESISTANCE AND ULTIMATELY ELECTED TO LEAVE THE EMBOLD IN THE PATIENT. THE PHYSICIAN USED EMBOLD 8X20 AND NON-BSC PACKING COILS TO BLOCK OFF THE PROXIMAL SPLENIC ARTERY. FOLLOW-UP CT IMAGING REVEALED THAT THE EMBOLD 6X20 HAD STRETCHED ALL THE WAY FROM THE SPLENIC ARTERY TO THE ACCESS SITE IN THE RIGHT GROIN. THE PATIENT WAS STARTED ON BABY ASPIRIN AND THE PHYSICIAN ORDERED FOLLOW UP IMAGING IN A COUPLE OF MONTHS. THERE WERE NO ADVERSE PATIENT SYMPTOMS AS A RESULT OF THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25231150 ↗
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Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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