IDC™ M0013615080Recalls & reported problems
Boston Scientific Corporation · Interlocking Detachable Coil · Class 2 · Implant
All models of IDC (7)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729158769), received between Feb 17, 2022 and Dec 1, 2022 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Migration” (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 16, 2026.
Most reported problems
Device problems
- Migration2
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Embolism/Embolus2
- Necrosis2
- Pancreatitis2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
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 ↗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 ↗
Other Device, Vascular, for Promoting Embolization devices
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- Azur CX Detachable 45-750824Microvention, Inc. · Device, Vascular, for Promoting Embolization115 reports
- Tornado G08261Cook Incorporated · Device, Vascular, for Promoting Embolization2 recalls7 reports
- Optima Coil System OPTI0930CSFMXBalt USA LLC · Device, Vascular, For Promoting Embolization2 recalls4 reports
- Optima Coil System OPTI0720CSFMXBalt USA LLC · Device, Vascular, For Promoting Embolization2 recalls4 reports
- Optima Coil System OPTI0413CSFMXBalt USA LLC · Device, Vascular, For Promoting Embolization2 recalls3 reports
- Prestige Coil System PRES0520HPKPLBalt USA LLC · Device, Vascular, For Promoting Embolization2 recalls3 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- 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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