InterlockRecalls & reported problems across all models

We found 26 models of Interlock by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 421 adverse event reports in the FDA's MAUDE database, received between Aug 14, 2018 and Sep 23, 2026 — classified as 58 injuries, 363 malfunctions.

The most frequently reported specific device problem is “Entrapment of Device” (126 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 Interlock problems

Interlock models

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

• Interlock™ M001361570

  Device, Vascular, for Promoting Embolization
  46 reports
• Interlock™ M001361960

  Device, Vascular, for Promoting Embolization
  44 reports
• Interlock™ M001361580

  Device, Vascular, for Promoting Embolization
  35 reports
• Interlock™ M001361530

  Device, Vascular, for Promoting Embolization
  34 reports
• Interlock™ M001361920

  Device, Vascular, for Promoting Embolization
  31 reports
• Interlock™ M001361510

  Device, Vascular, for Promoting Embolization
  26 reports
• Interlock™ M001361640

  Device, Vascular, for Promoting Embolization
  23 reports
• Interlock™ M001361500

  Device, Vascular, for Promoting Embolization
  22 reports
• Interlock™ M001361930

  Device, Vascular, for Promoting Embolization
  22 reports
• Interlock™ M001361600

  Device, Vascular, for Promoting Embolization
  21 reports
• Interlock™ M001361620

  Device, Vascular, for Promoting Embolization
  18 reports
• Interlock™ M001361550

  Device, Vascular, for Promoting Embolization
  17 reports
• Interlock™ M001361940

  Device, Vascular, for Promoting Embolization
  17 reports
• Interlock™ M001361520

  Device, Vascular, for Promoting Embolization
  10 reports
• Interlock™ M001361950

  Device, Vascular, for Promoting Embolization
  10 reports
• Interlock™ M001361590

  Device, Vascular, for Promoting Embolization
  9 reports
• Interlock™ M001361490

  Device, Vascular, for Promoting Embolization
  7 reports
• Interlock™ M001361560

  Device, Vascular, for Promoting Embolization
  5 reports
• Interlock™ M001361610

  Device, Vascular, for Promoting Embolization
  4 reports
• Interlock™ M001361740

  Device, Vascular, for Promoting Embolization
  4 reports
• Interlock™ M001361480

  Device, Vascular, for Promoting Embolization
  4 reports
• Interlock™ M001361540

  Device, Vascular, for Promoting Embolization
  3 reports
• Interlock™ M001361630

  Device, Vascular, for Promoting Embolization
  3 reports
• Interlock™ M001361760

  Device, Vascular, for Promoting Embolization
  3 reports
• Interlock™ M001361770

  Device, Vascular, for Promoting Embolization
  2 reports
• Interlock™ M001361750

  Device, Vascular, for Promoting Embolization
  1 report

Recent Interlock adverse event reports

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

• MalfunctionSep 23, 2026Difficult to Remove; Failure to Advance; Adverse Event Without Identified Device or Use Problem

  Reportable based on device analysis completed on 01Sep2026.It was reported that the coil was unable to advance and withdraw from the microcatheter.A 10mm x 50cm Interlock coil was selected for use. However, during the procedure, it was noted that the coil got stuck with a non-Boston Scientific microcatheter after crossing the hub and was not able to remove. As a result, the entire catheter assembly was removed. The procedure was completed with another Interlock coil. There were no patient complications as a result of this event.However, device analysis revealed the pusher wire was detached from the Heat Shrink TFE tubing section.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50867334 ↗
• InjuryJul 20, 2026Break; Stretched; Separation Failure

  IT WAS REPORTED THAT A COIL BREAK OCCURRED, REQUIRING ADDITIONAL INTERVENTION. THE NON-STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND NON-CALCIFIED SPLENIC ARTERY. A 3 MM X 12 CM INTERLOCK COIL WAS SELECTED FOR A SPLENIC ARTERY EMBOLIZATION PROCEDURE. DURING THE PROCEDURE, AFTER REACHING THE TARGET LESION, COIL DETACHMENT WAS ATTEMPTED. HOWEVER, THE COIL DID NOT DETACH PROPERLY. UNRAVELING OCCURRED WHILE MOVING NOT ONLY THE DELIVERY WIRE BUT ALSO THE ENTIRE CATHETER BACK AND FORTH. ATTEMPTS WERE MADE TO RETRIEVE THE COIL USING A NON-BOSTON SCIENTIFIC 2TIP STRAIGHT MICROCATHETER AND A SNARE, BUT RETRIEVAL WAS UNSUCCESSFUL. UPON RETRIEVAL, FLUOROSCOPIC IMAGING OF THE ABDOMINAL AORTA CONFIRMED SEPARATION OF THE INTERLOCKING ARM ON THE DELIVERY WIRE SIDE, WHICH REMAINED WITHIN THE ABDOMINAL AORTA. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 25876917 ↗
• InjuryJun 18, 2026Migration

  IT WAS REPORTED THAT COIL PACK MIGRATION OCCURRED REQUIRING ADDITIONAL INTERVENTION. THE TARGET LESION WAS LOCATED IN THE MILDLY CALCIFIED SUBCLAVIAN VESSEL. A 12 MM X 30 CM INTERLOCK WAS SELECTED FOR USE. THE COIL PACK WAS INITIALLY SUCCESSFULLY IMPLANTED. THE PATIENT WAS BROUGHT TO THE CARDIAC INTENSIVE CARE UNIT (CICU), HAD AN X-RAY AND IT WAS NOTED THAT THE COIL MIGRATED TO THE BRONCHIAL ARTERY DUE TO AN ANTEROGRADE FLOW LIKELY CAUSED BY THE STENT GRAFT. THE PATIENT RETURNED THE FOLLOWING DAY, ONE DAY POST OP AND THE COIL PACK WAS SUCCESSFULLY REMOVED VIA SNARE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 25549314 ↗
• MalfunctionMay 8, 2026Difficult to Insert; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2026. IT WAS REPORTED THAT THE DEVICE WAS DIFFICULT TO INSERT. A 4MM X 15CM INTERLOCK COIL WAS SELECTED FOR USE IN THE LEFT ATRIUM. THE ANATOMY WAS MODERATELY TORTUOUS. AN ATTEMPT WAS MADE TO PLACE THE COIL IN THE LEFT ATRIUM, BUT THE NON-BOSTON SCIENTIFIC MICROCATHETER DEVIATED FROM THE ELECTED BLOOD VESSEL. CONSEQUENTLY, THE INTERLOCK COIL WAS REMOVED, AND THE MICROCATHETER WAS REINSERTED INTO THE LEFT ATRIUM. THE SAME COIL WAS ATTEMPTED TO BE INSERTED INTO THE MICROCATHETER, BUT THERE WAS SEVERE RESISTANCE IN THE INSERTER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. HOWEVER, DEVICE ANALYSIS REVEALED PUSHER WIRE DETACHMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25129690 ↗
• MalfunctionMay 7, 2026Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED. THE TARGET LESION WAS LOCATED IN THE INTERNAL ILIAC ARTERY (IIA). A 12MM X 30CM PE F-IDC COIL WAS SELECTED FOR USE. DURING THE PROCEDURE, THE COIL WAS INSERTED INTO THE CATHETER. HOWEVER, THE COIL WAS UNABLE TO PASS THE ANGULATION OF IIA DUE TO TORTUOSITY. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25117948 ↗
• MalfunctionApr 24, 2026Break

  IT WAS REPORTED THAT COIL DETACHMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE ILIAC ARTERY. A 14MM X 30CM PE F-IDC COIL WAS SELECTED FOR USE. DURING ADVANCEMENT AND POSITIONING, THE CONNECTION BETWEEN THE COIL AND THE SHAFT WAS FRACTURED SUDDENLY AND THE COIL WAS DETACHED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24982890 ↗
• MalfunctionApr 23, 2026Difficult to Remove; Stretched; Separation Failure; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2026. IT WAS REPORTED THAT COIL FAILED TO SEPARATE AND STRETCH OCCURRED. THE TARGET LESION WAS LOCATED IN THE PELVIC VEINS. A 2D 10MM X 30CM INTERLOCK WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS FOUND THAT THE COIL COULD NOT BE DEPLOYED AND PULLED OUT. UPON RETRIEVAL OF THE COIL, IT WAS OBSERVED TO BE VERY TIGHT AND HAD BEEN STRETCHED DURING REMOVAL. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED AN ARM COIL DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24971613 ↗
• MalfunctionApr 21, 2026Stretched; Failure to Advance; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 27MAR2026. IT WAS REPORTED THAT DEVICE UNABLE TO ADVANCE AND STRETCHED OCCURRED. THE TARGET LESION WAS LOCATED IN THE ARM. A 5MM X 15CM INTERLOCK WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL COULD NOT BE PUSHED OUT OF THE SHEATH. UPON REMOVAL, THE COIL WAS STRETCHED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A BROKEN PUSHER WIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24939785 ↗
• MalfunctionMar 31, 2026Stretched; Failure to Advance; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS ON 27FEB2026. IT WAS REPORTED THAT THE COIL COULD NOT ADVANCE IN THE MICROCATHETER. THE PATIENT UNDERWENT TRANSCATHETER EMBOLIZATION OF A SPLENIC ANEURYSM UNDER LOCAL ANESTHESIA. THE TARGET LESION WAS LOCATED IN THE LEFT FEMORAL ARTERY. AN STC MICROCATHETER AND 18 CONTROLLABLE COILS WERE UTILIZED FOR EMBOLIZATION. THE INITIAL COILS, 14 MM X 30 CM, 12 MM X 30 CM, AND 10 MM X 30 CM WERE DELIVERED WITHOUT DIFFICULTY. HOWEVER, THE FINAL 6 MM X 20 CM CONTROLLABLE COIL WAS ADVANCED INTO THE MICROCATHETER AND BECAME STUCK. DESPITE REPEATED ATTEMPTS, ADVANCEMENT WAS UNSUCCESSFUL, AND THE COIL WAS SUBSEQUENTLY WITHDRAWN. UPON INSPECTION, THE CONTROLLABLE COIL WAS NOTED TO BE STRETCHED. A SECOND 6 MM X 20 CM CONTROLLABLE COIL WAS THEN SELECTED AND DELIVERED USING THE SAME STC BOSTON SCIENTIFIC MICROCATHETER. THIS COIL WAS DEPLOYED WITHOUT DIFFICULTY, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT, AND THE PATIENT WAS STABLE POST-PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE COIL ARM WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24741140 ↗
• InjuryFeb 25, 2026Separation Failure

  IT WAS REPORTED THAT COIL FAILED TO DEPLOY REQUIRING INTERVENTION. THE TARGET LESION WAS LOCATED VESSEL IN THE DIGESTIVE TRACT. A 2D 20MM X 50CM PE F-IDC WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL COULD NOT BE DEPLOYED. THE DEVICE WAS REMOVED WITH THE ASSISTANCE OF A SNARE, AND NO DEVICE FRAGMENTS WERE FOUND IN THE BLOOD VESSEL. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. IT WAS FURTHER CONFIRMED THAT THERE WERE NO OBSERVATIONS OF PREMATURE DEPLOYMENT, COIL BREAK OR MALPOSITION OF THE COIL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24442788 ↗
• MalfunctionJan 26, 2026Separation Failure; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 30DEC2025. IT WAS REPORTED THAT THE COIL DID NOT DEPLOY. THE NON STENOSED TARGET LESION WAS LOCATED IN A NON-TORTUOUS AND NON-CALCIFIED VESSEL OF PROSTATE. A 2/3MM X 2.3CM INTERLOCK WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL GOT STUCK AND DID NOT DEPLOY. THE COIL WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. HOWEVER, DEVICE ANALYSIS REVEALED DETACHED PUSHER WIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24179468 ↗
• MalfunctionJan 7, 2026Difficult to Remove; Failure to Advance; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 12DEC2025. THE TARGET LESION WAS LOCATED IN THE PSEUDOANEURYSM OF THE RIGHT THIGH. A 3MM X 12CM PE F-IDC COIL WAS SELECTED FOR USE IN A PERCUTANEOUS ARTERIAL EMBOLIZATION. DURING THE PROCEDURE, THE COIL WAS STUCK AT THE TIP OF THE MICROCATHETER. MULTIPLE ATTEMPTS TO PUSH IT WERE UNSUCCESSFUL, AND THE COIL COULD NOT BE WITHDRAWN. CONSEQUENTLY, THE COIL WAS REMOVED TOGETHER WITH THE MICROCATHETER, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE ARM COIL WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23996617 ↗
• MalfunctionDec 22, 2025Premature Activation; Difficult to Remove; Failure to Advance; Adverse Event Without Identified Device or Use Problem; Premature Activation; Difficult to Remove; Failure to Advance; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 10DEC2025. IT WAS REPORTED THAT THE COIL COULD NOT BE PUSHED OUT AND WAS DETACHED BY ITSELF IN THE PROTECTIVE SHEATH. THE TARGET LESION WAS LOCATED IN THE UTERINE ARTERY. A 4MM X 15CM INTERLOCK COIL WAS SELECTED FOR TRANSCATHETER EMBOLIZATION. HOWEVER, DURING ADVANCING, IT WAS NOTED THAT THE COIL COULD NOT BE PUSHED OUT OF THE BOSTON SCIENTIFIC STC 18 MICROCATHETER. AFTER THE COIL WAS WITHDRAWN FROM THE BODY, IT WAS FOUND THAT THE COIL WAS DETACHED BY ITSELF IN THE PROTECTIVE SHEATH, AND THE COIL WAS STUCK IN THE MICROCATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT, AND THE PATIENT WAS STABLE POST-PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED THE ARM COIL WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23866202 ↗
• MalfunctionDec 19, 2025Premature Activation; Failure to Advance; Adverse Event Without Identified Device or Use Problem; Premature Activation; Failure to Advance; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON THE DEVICE ANALYSIS COMPLETED ON 5DEC2025. IT WAS REPORTED THAT UNABLE TO ADVANCE IN CATHETER OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE CORONARY ARTERIOVENOUS FISTULA. A 3MM X 12CM INTERLOCK WAS SELECTED FOR USE. DURING THE PROCEDURE, COIL COULD NOT BE ADVANCED THROUGH THE STC18 MICROCATHETER DESPITE MULTIPLE ATTEMPTS AND FLUSHING. THE PHYSICIAN ATTEMPTED TO WITHDRAW THE COIL, IT BECAME DETACHED WITHIN THE DELIVERY SYSTEM AND COULD NOT BE RETRACTED INTO THE PROTECTIVE SHEATH AT THE Y-VALVE. THE COIL WAS REPLACED WITH ANOTHER DEVICE OF THE SAME TYPE, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED PUSHER WIRE DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23849733 ↗
• MalfunctionDec 16, 2025Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED COIL WAS BROKEN INSIDE THE CATHETER. THE TARGET LESION WAS LOCATED IN THE A 20MM X 50CM INTERLOCK COIL WAS SELECTED FOR SPLENIC ANEURYSM EMBOLIZATION. HOWEVER, IT WAS NOTED THAT THE COIL WAS BROKEN INSIDE THE CATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT, AND THE PATIENT WAS STABLE POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23818519 ↗

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