Interlock-35Recalls & reported problems across all models
Boston Scientific Corporation · 25 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 712
- Deaths reported
- 1
- Injuries reported
- 44
- Recalls
- 0
We found 25 models of Interlock-35 by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 712 adverse event reports in the FDA's MAUDE database, received between Aug 22, 2017 and Aug 12, 2026 — classified as 1 death, 44 injuries, 667 malfunctions.
The most frequently reported specific device problem is “Failure to Advance” (245 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 Interlock-35 problems
Device problems
- Failure to Advance245
- Adverse Event Without Identified Device or Use Problem171
- Entrapment of Device156
- Premature Activation143
- Stretched123
- Difficult to Remove91
- Physical Resistance/Sticking85
- Separation Failure81
Patient problems
- No Clinical Signs, Symptoms or Conditions502
- No Consequences Or Impact To Patient188
- Complaint, Ill-Defined4
- Device Embedded In Tissue or Plaque3
- Foreign Body In Patient3
- Pain3
- Discomfort2
- No Known Impact Or Consequence To Patient2
Interlock-35 models
25 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Interlock™-35 M001363830Device, Vascular, for Promoting Embolization98 reports
- Interlock™-35 M001363590Device, Vascular, for Promoting Embolization92 reports
- Interlock™-35 M001363800Device, Vascular, for Promoting Embolization86 reports
- Interlock™-35 M001363630Device, Vascular, for Promoting Embolization72 reports
- Interlock™-35 M001363820Device, Vascular, for Promoting Embolization1 death65 reports
- Interlock™-35 M001363610Device, Vascular, for Promoting Embolization60 reports
- Interlock™-35 M001363650Device, Vascular, for Promoting Embolization34 reports
- Interlock™-35 M001363670Device, Vascular, for Promoting Embolization33 reports
- Interlock™-35 M001363550Device, Vascular, for Promoting Embolization32 reports
- Interlock™-35 M001363620Device, Vascular, for Promoting Embolization22 reports
- Interlock™-35 M001363760Device, Vascular, for Promoting Embolization20 reports
- Interlock™-35 M001363580Device, Vascular, for Promoting Embolization19 reports
- Interlock™-35 M001363600Device, Vascular, for Promoting Embolization17 reports
- Interlock™-35 M001363520Device, Vascular, for Promoting Embolization14 reports
- Interlock™-35 M001363500Device, Vascular, for Promoting Embolization9 reports
- Interlock™-35 M001363730Device, Vascular, for Promoting Embolization7 reports
- Interlock™-35 M001363810Device, Vascular, for Promoting Embolization6 reports
- Interlock™-35 M001363640Device, Vascular, for Promoting Embolization6 reports
- Interlock™-35 M001363790Device, Vascular, for Promoting Embolization5 reports
- Interlock™-35 M001363660Device, Vascular, for Promoting Embolization5 reports
- Interlock™-35 M001363540Device, Vascular, for Promoting Embolization4 reports
- Interlock™-35 M001363720Device, Vascular, for Promoting Embolization2 reports
- Interlock™-35 M001363930Device, Vascular, for Promoting Embolization2 reports
- Interlock™-35 M001363700Device, Vascular, for Promoting Embolization1 report
- Interlock™-35 M001363910Device, Vascular, for Promoting Embolization1 report
Recent Interlock-35 adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionAug 12, 2026Contamination; Adverse Event Without Identified Device or Use Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50223109 ↗MalfunctionJul 6, 2026Failure to Advance; Adverse Event Without Identified Device or Use Problem
REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2026. IT WAS REPORTED THAT THE COIL WAS UNABLE TO ADVANCE IN THE CATHETER. A 6MM X 20CM INTERLOCK-35 WAS SELECTED FOR USE. DURING THE PROCEDURE, THE COIL DID NOT COME OUT OF THE CATHETER. 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 ARM COIL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25725402 ↗MalfunctionJun 30, 2026Difficult to Remove; Failure to Advance; Adverse Event Without Identified Device or Use Problem
REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2026. AN INTERLOCK? -35 EMBOLIC COIL WAS SELECTED FOR USE IN AN EMBOLIZATION PROCEDURE FOR PELVIC CONGESTION SYNDROME (PCS). DURING THE PROCEDURE, THERE WAS DIFFICULTY/INABILITY ADVANCING AND RETRACTING THE COIL. THE COIL COULD NOT BE DEPLOYED. THE COIL HAD TO BE WITHDRAWN TOGETHER WITH THE CATHETER. 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 THE INTERLOCKING ARM OF THE COIL WAS DETACHED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25668784 ↗MalfunctionJun 30, 2026
BOSTON SCIENTIFC COIL DID NOT DEPLOY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25665449 ↗MalfunctionJun 24, 2026Premature Activation; Adverse Event Without Identified Device or Use Problem
REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 26MAY2026. IT WAS REPORTED THAT THE COIL PREMATURELY DEPLOYED. A 6MM X 20CM INTERLOCK .035 COIL WAS SELECTED FOR USE IN THE STOMACH. DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL WAS DETACHED IN THE MICROCATHETER. 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 THAT THE MAIN COIL ARM WAS WAS DETACHED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25610805 ↗MalfunctionJun 12, 2026Failure to Advance; Adverse Event Without Identified Device or Use Problem
REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2026. IT WAS REPORTED THAT DEVICE UNABLE TO ADVANCE OCCURRED. THE TARGET LESION WAS LOCATED IN THE MILD TORTUOUS AND MILD CALCIFIED SUBCLAVIANE. A 2D 8MM X 40CM .035 INTERLOCK WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL GOT STUCK IN THE CATHETER DISTAL PART. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A MAIN COIL DETACHED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25492296 ↗MalfunctionJun 4, 2026Premature Activation; Difficult to Advance; Adverse Event Without Identified Device or Use Problem
REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2026. IT WAS REPORTED THAT THE COIL DIFFICULT TO ADVANCE AND PREMATURE DEPLOYMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE INTERNAL ILIAC ANEURYSM. A 20MM X 40CM INTERLOCK .035 COIL WAS SELECTED FOR EMBOLIZATION. HOWEVER, RESISTANCE WAS ENCOUNTERED DURING THE DELIVERY PROCESS OF THE COIL. AFTER REPEATED ATTEMPTS, THE INTERLOCKING ARM DISLODGED. 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 A DETACHED COIL ARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25392670 ↗MalfunctionMay 28, 2026Premature Activation; Adverse Event Without Identified Device or Use Problem
REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2026. IT WAS REPORTED THAT PREMATURE DEPLOYMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE ABDOMINAL AORTA. A 10MM X 40CM INTERLOCK .035 WAS SELECTED FOR USE. DURING THE DELIVERY PROCESS, THE COIL WAS FOUND TO BE DISLODGED, AND THE WHOLE CONTRAST CATHETER WAS WITHDRAWN FROM THE BODY. 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 THE COIL ARM WAS DETACHED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25322701 ↗MalfunctionMay 28, 2026Break; Nonstandard Device; Difficult to Remove
IT WAS REPORTED THAT THE MAIN COIL ARM DETACHED DURING THE PROCEDURE. THE TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND MODERATELY CALCIFIED INTERNAL ILIAC ARTERY (IIA). A 6 MM X 10 CM INTERLOCK-35 COIL WAS SELECTED FOR USE. AFTER THE COIL WAS PLACED AT THE TARGET LESION, RESISTANCE WAS ENCOUNTERED WHILE RETRIEVING THE DELIVERY WIRE. THE WIRE WAS PUSHED AND PULLED AGAIN, AFTER WHICH THE RESISTANCE CHANGED, AND THE DELIVERY WIRE WAS REMOVED FROM THE PATIENT. INSPECTION OUTSIDE THE BODY SHOWED A FRAGMENT OF THE INTERLOCKING ARM SECTION ATTACHED TO THE TIP OF THE DELIVERY WIRE. THE DAMAGE INVOLVED THE INTERLOCKING ARM SECTION AND NOT THE COIL PORTION. IT WAS NOTED THAT THERE MAY HAVE BEEN AN ABNORMALITY IN THE SHAPE OF THE INTERLOCK ARM. THE FRAGMENT WAS SUCCESSFULLY RETRIEVED, AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25322637 ↗MalfunctionMay 27, 2026Stretched; Failure to Advance; 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 ADVANCED FROM THE CATHETER AND WAS STRETCHED. A 10MM X 40CM INTERLOCK .035 COIL WAS SELECTED FOR USE IN THE INTERNAL ILIAC ARTERY. DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL COULD NOT BE PUSHED OUT THE ANGIOGRAPHY CATHETER. THE COIL WAS WITHDRAWN AND IT WAS FOUND THE COIL WAS STRETCHED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. HOWEVER, DEVICE ANALYSIS REVEALED A DETACHED INTERLOCKING ARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25308375 ↗MalfunctionMay 21, 2026Device-Device Incompatibility
IT WAS REPORTED THAT THE CATHETER WAS PUNCTURED BY THIS DEVICE. AN 8MM X 40CM INTERLOCK-35 WAS SELECTED FOR USE IN A VARICOCELE EMBOLIZATION PROCEDURE. DURING THE PROCEDURE, THE INTERLOCK-35 GUIDE PUSHER PUNCTURED THE 5F NON-BOSTON SCIENTIFIC CATHETER. THE COIL WAS SUCCESSFULLY RELEASED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25248314 ↗MalfunctionMay 20, 2026Device-Device Incompatibility; Difficult to Advance
IT WAS REPORTED THAT A COIL PIERCED THE CATHETER. DURING AN INTERNAL ILIAC BONE EMBOLIZATION PROCEDURE, AN 8 MM X 20 CM INTERLOCK-35 COIL WAS SELECTED FOR USE. THE ANATOMY WAS REPORTED AS MODERATELY TORTUOUS. AN INTERMITTENT FLUSH SETUP WAS UTILIZED, AND A FLUSH WAS PERFORMED PRIOR TO INSERTION OF THE COIL. THE COIL WAS USED IN COMBINATION WITH A NON-BOSTON SCIENTIFIC ANGIOGRAPHIC CATHETER WITH AN INTERNAL DIAMETER OF 0.038 INCH. DURING THE PROCEDURE, THE LOCKING ARM PORTION OF THE INTERLOCK DEVICE DID NOT FOLLOW THE CURVE OF THE CATHETER, RESULTING IN PIERCING THE CATHETER AND PROTRUSION INTO THE BLOOD VESSEL. THERE WAS NO VASCULAR DAMAGE. THE PROCEDURE WAS ABLE TO BE COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25236186 ↗MalfunctionMay 19, 2026Premature Activation; Difficult to Remove; Failure to Advance; 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 ADVANCED AND WITHDRAWN FROM THE CATHETER. A 15MM X 40CM INTERLOCK .035 COIL WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL WAS STUCK IN THE CATHETER AND COULD NOT BE WITHDRAWN. 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 THAT THE MAIN COIL WAS BENT AND STRETCHED AT THE PRIMARY COIL SECTION, MOREOVER THE ARM COIL WAS DETACHED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25222640 ↗MalfunctionMay 18, 2026Failure to Advance; Adverse Event Without Identified Device or Use Problem
REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2026. IT WAS REPORTED THAT THE MAIN COIL COULD NOT BE PUSHED. THE PATIENT PRESENTED WITH BILATERAL ILIAC ANEURYSMS, INCLUDING INVOLVEMENT OF THE INTERNAL ILIAC ARTERY. A 15MM X 40CM INTERLOCK 35 WAS SELECTED FOR EMBOLIZATION. ACCESS WAS OBTAINED VIA THE LEFT PUNCTURE SITE, AND A GUIDEWIRE WAS ADVANCED INTO THE RIGHT INTERNAL ILIAC ARTERY. FOLLOWING GUIDEWIRE PLACEMENT, ANGIOGRAPHY WAS PERFORMED USING A CORDIS 5F ANGIOGRAPHY CATHETER POSITIONED AT THE TARGET EMBOLIZATION SITE. THE 15MM X 40CM INTERLOCK-35 COIL WAS ADVANCED; HOWEVER, THE COIL COULD NOT BE PUSHED OUT OF THE CATHETER FOR DEPLOYMENT. MULTIPLE ATTEMPTS WERE MADE BY THE PHYSICIAN TO DEPLOY THE COIL, BUT THESE ATTEMPTS WERE UNSUCCESSFUL. THE DEVICE WAS REMOVED AND REPLACED WITH ANOTHER 15MM X 40CM INTERLOCK-35 COIL OF THE SAME SPECIFICATION, WHICH WAS SUCCESSFULLY USED TO COMPLETE THE EMBOLIZATION. THE PATIENT REMAINED STABLE FOLLOWING THE PROCEDURE 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 25205160 ↗MalfunctionMay 18, 2026Nonstandard Device; 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 DEPLOYED. A 10MM X 40CM INTERLOCK .035 OIL WAS SELECTED FOR LEFT SUBCLAVIAN ARTERY EMBOLIZATION. A NON-BOSTON SCIENTIFIC DELIVERY COIL WAS USED AND CONTINUOUS FLUSHING WITH HEPARINIZED SALINE WAS PERFORMED THROUGHOUT THE PROCEDURE. FLUSHING WAS DONE BEFORE INTRODUCING THE COIL. AFTER THE COIL WAS ADVANCED INTO POSITION, IT WAS FOUND THAT THE COIL AND THE INTERLOCKING ARM COULD NOT BE DETACHED. MULTIPLE ATTEMPTS WERE UNSUCCESSFUL, SO THE COIL WAS WITHDRAWN FROM THE BODY. IT WAS DISCOVERED THAT THE INTERLOCKING ARMS COULD NOT BE RE-FASTENED. 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 CORE WIRE OF THE DELIVERY WIRE WAS DETACHED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25201508 ↗
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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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