IDCRecalls & reported problems across all models

We found 7 models of IDC by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 23 adverse event reports in the FDA's MAUDE database, received between Dec 13, 2018 and Feb 12, 2026 — classified as 1 death, 10 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Migration” (5 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 IDC problems

IDC models

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

• IDC™ M0013614120

  Device, Vascular, for Promoting Embolization
  5 reports
• IDC™ M0013612040

  Device, Vascular, for Promoting Embolization
  4 reports
• IDC™ M0013613100

  Device, Vascular, for Promoting Embolization
  4 reports
• IDC™ M0013614080

  Device, Vascular, for Promoting Embolization
  3 reports
• IDC™ M0013615080

  Device, Vascular, for Promoting Embolization
  3 reports
• IDC™ M0033612020

  Device, Vascular, for Promoting Embolization
  1 death2 reports
• IDC™ M0013615120

  Device, Vascular, for Promoting Embolization
  2 reports

Recent IDC adverse event reports

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

• InjuryFeb 12, 2026Break; Stretched; Material Protrusion/Extrusion

  IT WAS REPORTED THAT THE COIL UNRAVELED AND PROTRUDED FROM THE TARGET LOCATION, REQUIRING ADDITIONAL INTERVENTION. AN IDC 18 SOFT COIL 4MM X 8CM WAS SELECTED FOR A VARICOELE EMBOLIZATION PROCEDURE. THE IDC 18 SOFT COIL 4MM X 8CM WAS IMPLANTED IN ADDITION TO MULTIPLE OTHER EMBOLIC COILS. WHEN DEPLOYING THIS COIL, HOWEVER, THERE WERE SLIGHT ISSUES DURING DEPLOYMENT, AND THE COIL WAS RE-SHEATHED AS IT DIDN'T DEPLOY CORRECTLY. THE ORIGINAL DEVICE WAS USED TO COMPLETE THE PROCEDURE. OVERNIGHT, THE PATIENT EXPERIENCED PAIN AND DISCOMFORT AND NOTICED A COIL PROTRUDING OUT OF AN OPEN-WOUND SCALPEL INCISION IN THEIR GROIN. A COMPLEX EXTRACTION WAS PLANNED FOR THE NEXT DAY. AT THE TIME OF PRESENTATION, IT SEEMED THE COIL WAS SANDWICHED BETWEEN SEVERAL OTHER COILS USED DURING VARICOCOELE EMBOLISATION. THEREFORE, SIMPLY PULLING IT WAS NOT FEASIBLE AS THIS RISKED DISLODGING PROXIMAL COILS. INSTEAD, IT WAS APPROACHED FROM THE NECK AND GROIN AT THE SAME TIME, AND THEY WERE ABLE TO SNAP THE COIL IN THE RENAL VEIN. DURING THE EXTRACTION, THE COIL WAS HALF-REMOVED, WITH A SMALL AMOUNT LEFT WITHIN THE RENAL VEIN. NO COIL WAS LEFT IN THE INFERIOR VENA CAVA (IVC) OR RIGHT COMMON ILIAC VEIN (RCIV).

  Patient problems: Discomfort; Foreign Body In Patient; Pain

  MAUDE report 24323196 ↗
• MalfunctionNov 7, 2024Break; Difficult to Remove; Break; Difficult to Remove

  IT WAS REPORTED THAT THE COIL GOT SEPARATED. THE STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS VESSEL. A 2MM X 4CM IDC EMBOLICS WAS SELECTED FOR USE. DURING THE PROCEDURE, AN ATTEMPT WAS MADE TO RETRACT THE COIL INTO THE OUTER SHEATH, BUT IT COULD NOT BE WITHDRAWN, LEADING TO THE COIL BECOMING DETACHED. THE DEVICE WAS REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE THERE WERE NO PATIENT COMPLICATIONS REPORTED. IT WAS FURTHER REPORTED THAT THE COIL DETACHED FROM THE LOCKING ARM WHEN RETRACTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20630955 ↗
• InjuryOct 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED REBLEEDING AND LOW HEMOGLOBIN LEVELS. THE PATIENT PRESENTED WITH A HISTORY OF PANCREATITIS, WHICH LED TO ACTIVE BLEEDING. THE PREFERRED TREATMENT FOR THIS CONDITION IS TO OCCLUDE THE PSEUDOANEURYSM USING AN INTERVENTIONAL PROCEDURE. ON (B)(6) 2024, A NON-BOSTON SCIENTIFIC (BSC) COIL WAS PLACED PERCUTANEOUSLY INSIDE THE PSEUDOANEURYSM. ON (B)(6) 2024, A COMPUTED TOMOGRAPHY (CT) SCAN DOCUMENTED THAT THE PSEUDOANEURYSM REMAINS PERMEABLE. THIS IS LIKELY DUE TO THE USE OF A SINGLE COIL, WHICH DID NOT ACHIEVE TOTAL THROMBOSIS OF THE PSEUDOANEURYSM. ON (B)(6) 2024, A 3MM X 12CM INTERLOCK, 3MM X 10CM IDC, AND 2MM X 4CM IDC WERE PLACED ENDOVASCULARLY AT THE ORIGIN OF THE LEFT GASTRIC ARTERY, WHICH PROVIDED IRRIGATION TO THE LEFT GASTRIC ARTERY. ON (B)(6) 2024, A CT SCAN WAS PERFORMED DUE TO REBLEEDING AND LOW HEMOGLOBIN LEVELS, FINDING A PERMEABLE PSEUDOANEURYSM AFTER OCCLUSION OF THE NOURISHING ARTERY WITH THE BSC THREE COILS. ON (B)(6) 2024, BASED ON THE TOMOGRAPHY FINDINGS, THE PHYSICIAN DECIDED TO PLACE ADDITIONAL NON-BOSTON SCIENTIFIC COILS. A REPEAT CONTROL AT 15 MINUTES SHOWED NO VISUALIZED FLOW DISTAL TO THE COILS INSIDE THE LEFT GASTRIC

  Patient problems: Anemia; Hemorrhage/Blood Loss/Bleeding; Pseudoaneurysm

  MAUDE report 20347330 ↗
• InjuryOct 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED REBLEEDING AND LOW HEMOGLOBIN LEVELS. THE PATIENT PRESENTED WITH A HISTORY OF PANCREATITIS, WHICH LED TO ACTIVE BLEEDING. THE PREFERRED TREATMENT FOR THIS CONDITION IS TO OCCLUDE THE PSEUDOANEURYSM USING AN INTERVENTIONAL PROCEDURE. ON (B)(6) 2024, A NON-BOSTON SCIENTIFIC (BSC) COIL WAS PLACED PERCUTANEOUSLY INSIDE THE PSEUDOANEURYSM. ON (B)(6) 2024, A COMPUTED TOMOGRAPHY (CT) SCAN DOCUMENTED THAT THE PSEUDOANEURYSM REMAINS PERMEABLE. THIS IS LIKELY DUE TO THE USE OF A SINGLE COIL, WHICH DID NOT ACHIEVE TOTAL THROMBOSIS OF THE PSEUDOANEURYSM. ON (B)(6) 2024, A 3MM X 12CM INTERLOCK, 3MM X 10CM IDC, AND 2MM X 4CM IDC WERE PLACED ENDOVASCULARLY AT THE ORIGIN OF THE LEFT GASTRIC ARTERY, WHICH PROVIDED IRRIGATION TO THE LEFT GASTRIC ARTERY. ON (B)(6) 2024, A CT SCAN WAS PERFORMED DUE TO REBLEEDING AND LOW HEMOGLOBIN LEVELS, FINDING A PERMEABLE PSEUDOANEURYSM AFTER OCCLUSION OF THE NOURISHING ARTERY WITH THE BSC THREE COILS. ON (B)(6) 2024, BASED ON THE TOMOGRAPHY FINDINGS, THE PHYSICIAN DECIDED TO PLACE ADDITIONAL NON-BOSTON SCIENTIFIC COILS. A REPEAT CONTROL AT 15 MINUTES SHOWED NO VISUALIZED FLOW DISTAL TO THE COILS INSIDE THE LEFT GASTRIC

  Patient problems: Anemia; Hemorrhage/Blood Loss/Bleeding; Pseudoaneurysm

  MAUDE report 20346310 ↗
• MalfunctionApr 14, 2023Difficult to Remove; Stretched; Failure to Advance; Difficult to Remove; Stretched; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2023: IT WAS REPORTED THAT THE DEVICE WAS UNABLE TO ADVANCE. THE TARGET LESION WAS LOCATED IN MODERATELY TORTUOUS VESSEL. A 4MM X 12CM IDC 18 COIL WAS SELECTED FOR USE. DURING THE PROCEDURE, THE COIL GOT STUCK WITHIN THE MICROCATHETER AND THE DEVICE WAS UNRAVEL. THE COIL WAS REMOVED TOGETHER WITH THE MICROCATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE DAME DEVICE. NO COMPLICATIONS WERE REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED THAT THE MAIN COIL WAS DETACHED IN THE COIL ARM SECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16747339 ↗
• MalfunctionFeb 22, 2023Stretched; Adverse Event Without Identified Device or Use Problem; Stretched; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 26 JAN 2023. IT WAS REPORTED THAT THE COIL WAS DAMAGED. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND NON-CALCIFIED INTERNAL ILIAC ARTERY. A 4MM X 12CM IDC COIL WAS SELECTED FOR USE. DURING UNPACKING, IT WAS NOTED THAT THE DISTAL PORT OF THE DEVICE WAS STRETCHED. THE DEVICE WAS NOT PLACED INSIDE THE BODY AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED THE INTERLOCKING ARM WAS FOUND DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16424352 ↗
• InjuryDec 1, 2022Migration; Migration

  IT WAS REPORTED THAT THE COIL PACK MIGRATED. A 5MM X 8CM IDC-18 SOFT INTERLOCKING DETACHABLE COIL WAS SELECTED FOR USE IN AN EMBOLIZATION PROCEDURE TO TREAT A SPLENIC ARTERY ANEURYSM. NEAR THE END OF THE PROCEDURE, THE COIL PACK MIGRATED DOWNSTREAM AT LEAST 5CM DISTALLY IN THE SPLENIC ARTERY. THE COIL PACK CONTAINED NINE COILS. ALL DEVICES WERE LEFT INSIDE THE PATIENT. THE PATIENT WAS ADMITTED FOR OBSERVATION. TISSUE NECROSIS OCCURRED, AND THE PATIENT WAS TREATED FOR ACUTE PANCREATITIS. THE PATIENT WAS ULTIMATELY DISCHARGED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Embolism/Embolus; Necrosis; Pancreatitis

  MAUDE report 15900845 ↗
• InjuryDec 1, 2022Migration; Migration

  IT WAS REPORTED THAT THE COIL PACK MIGRATED. A 5MM X 8CM IDC-18 SOFT INTERLOCKING DETACHABLE COIL WAS SELECTED FOR USE IN AN EMBOLIZATION PROCEDURE TO TREAT A SPLENIC ARTERY ANEURYSM. NEAR THE END OF THE PROCEDURE, THE COIL PACK MIGRATED DOWNSTREAM AT LEAST 5CM DISTALLY IN THE SPLENIC ARTERY. THE COIL PACK CONTAINED NINE COILS. ALL DEVICES WERE LEFT INSIDE THE PATIENT. THE PATIENT WAS ADMITTED FOR OBSERVATION. TISSUE NECROSIS OCCURRED, AND THE PATIENT WAS TREATED FOR ACUTE PANCREATITIS. THE PATIENT WAS ULTIMATELY DISCHARGED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Embolism/Embolus; Necrosis; Pancreatitis

  MAUDE report 15900812 ↗
• MalfunctionNov 22, 2022Contamination; Material Integrity Problem; Packaging Problem; Contamination; Material Integrity Problem; Packaging Problem

  IT WAS REPORTED THAT THE STERILITY OF THE DEVICE WAS COMPROMISED. A 2MMX2CM IDC-18 SOFT COIL WAS SELECTED FOR USE. WHEN THE DEVICE WAS RECEIVED IN THE HEALTH CARE FACILITY FROM SHIPPING, IT WAS OBSERVED THAT THE PACKAGE WAS SMASHED IN THE CENTER OF THE HOOP. IT WAS NOTED THAT THE STERILITY OF THE DEVICE WAS COMPROMISED. THE OUTER PACKAGE WAS NOT DAMAGED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15847057 ↗
• MalfunctionNov 7, 2022Detachment of Device or Device Component

  EARLY 80¿S FEMALE WITH NEW ONSET OF RECTAL BLEEDING. PROCEDURE: INTERNAL MAMMARY ARTERY (IMA) ANGIOGRAM, LEFT COLIC ARTERY BRANCH IMA AND SUPERIOR ANGIOPLASTY RECTAL ARTERY ANGIOPLASTY. THERE WAS A DEPLOYMENT MALFUNCTION THEN THE MICROCATHETER BROKE NEAR THE HUB. NO KNOWN HARM TO PATIENT. ANOTHER DEVICE USED FOR PROCEDURE WITHOUT PROBLEMS. MANUFACTURER RESPONSE FOR DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION, IDC¿ (PER SITE REPORTER). WILL OBTAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15743049 ↗
• InjuryAug 8, 2022Premature Activation; Premature Activation

  IT WAS REPORTED A SNARE WAS USED TO RECOVER THE COIL AND THE PROCEDURE WAS CANCELLED. THE 9.8MMX2MM TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS ANTERIOR SUPERIOR PANCREATICODUODENAL ARTERY. A 3MMX10CM IDC WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE TIP OF THE COIL WAS CAUGHT IN THE COIL THAT WAS EMBOLIZED EARLIER AND EARLY DETACHED IN THE DISTAL PART OF THE CATHETER WHEN IT WAS FORCIBLY PULLED BACK. A SNARE WAS USED FOR REMOVAL AND DEVICE WAS RECOVERED. THE PROCEDURE WAS NOT COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15188317 ↗
• MalfunctionFeb 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2022. A 5MMX8CM IDC WAS RETURNED WITH NO REPORTED ISSUES. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE INTERLOCKING ARM WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13550375 ↗
• InjurySep 1, 2021Material Integrity Problem; Migration; Material Integrity Problem; Migration

  IT WAS REPORTED THAT THE DEVICE FLOWED TO THE PERIPHERY, EMBOLIZED AND WAS REMOVED BY SNARE. THE TARGET LESION AREA WAS LOCATED IN THE SEVERELY TORTUOUS RENAL ARTERY. A 5MM X 12CM IDC WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE DEVICE WAS DEPLOYED FULLY. HOWEVER, THE COIL COULD NOT BE CRIMPED WELL TO THE VESSEL AND FLOWED TO THE PERIPHERY. SUBSEQUENTLY, IT EMBOLIZED IN THE DISTAL PART OF THE LESION AND WAS REMOVED USING A GOOSENECK SNARE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO FURTHER PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12408030 ↗
• MalfunctionJun 1, 2021Entrapment of Device; Entrapment of Device

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 07MAY2021. IT WAS REPORTED THAT COIL WAS STUCK INSIDE THE CATHETER. A 3MM X 10CM IDC-18 WAS SELECTED FOR USE. DURING PROCEDURE, IT WAS NOTED THAT THE COIL GOT STUCK INSIDE THE RENEGADE CATHETER. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED A DETACHED INTERLOCKING ARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11917899 ↗
• InjuryMar 23, 2021Premature Activation; Malposition of Device; Premature Activation; Malposition of Device

  IT WAS REPORTED THAT THE COIL WAS NOT PLACED WITHIN THE TARGET LESION. A 4MMX12CM IDC EMBOLIC COIL WAS SELECTED FOR USE IN A CHEMO EMBOLIZATION OF THE LIVER PROCEDURE. THE 4MMX12CM IDC EMBOLIC COIL WAS ADVANCED THROUGH THE RENEGADE CATHETER AND DEPLOYED PREMATURELY NOT WITHIN THE INTENDED TARGET LOCATION OF THE LIVER. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11554622 ↗

Other Boston Scientific Corporation products

• INGEVITY MRI7 models · 16,601 reports
• INGEVITY+3 models · 16,054 reports
• EMBLEM S-ICD4 models · 13,295 reports · 1 recall
• WATCHMAN25 models · 8,024 reports · 6 recalls
• AMS 800 Artificial Urinary Sphincter31 models · 7,515 reports · 2 recalls
• ENDOTAK RELIANCE SG9 models · 6,540 reports · 2 recalls
• RELIANCE 4-FRONT11 models · 5,739 reports
• FINELINE II EZ Sterox6 models · 5,633 reports