RunWayRecalls & reported problems across all models
Boston Scientific Corporation · 18 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 36
- Deaths reported
- 3
- Injuries reported
- 2
- Recalls
- 0
We found 18 models of RunWay by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 36 adverse event reports in the FDA's MAUDE database, received between Oct 18, 2018 and Dec 3, 2024 — classified as 3 deaths, 2 injuries, 31 malfunctions.
The most frequently reported specific device problem is “Break” (15 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 RunWay problems
Device problems
- Break15
- Material Deformation8
- Detachment of Device or Device Component6
- Fracture6
- Adverse Event Without Identified Device or Use Problem3
- Device Contamination with Chemical or Other Material2
- Difficult to Remove2
- Packaging Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions21
- No Consequences Or Impact To Patient8
- No Known Impact Or Consequence To Patient3
- No Patient Involvement3
- Death1
- Hemorrhage/Blood Loss/Bleeding1
- No Code Available1
RunWay models
18 models, most reported first. Each model has its own page with its reports, recalls and device details.
- RunWay™ H749389695740CATHETER, PERCUTANEOUS2 deaths8 reports
- RunWay™ H74938969720CATHETER, PERCUTANEOUS6 reports
- RunWay™ H74938969060CATHETER, PERCUTANEOUS4 reports
- RunWay™ H74938969010CATHETER, PERCUTANEOUS2 reports
- RunWay™ H74938969190CATHETER, PERCUTANEOUS2 reports
- RunWay™ H749389695730CATHETER, PERCUTANEOUS2 reports
- RunWay™ H74938969020CATHETER, PERCUTANEOUS1 report
- RunWay™ H74938969070CATHETER, PERCUTANEOUS1 report
- RunWay™ H74938969250CATHETER, PERCUTANEOUS1 death1 report
- RunWay™ H74938969260CATHETER, PERCUTANEOUS1 report
- RunWay™ H749389692930CATHETER, PERCUTANEOUS1 report
- RunWay™ H749389695750CATHETER, PERCUTANEOUS1 report
- RunWay™ H749389695830CATHETER, PERCUTANEOUS1 report
- RunWay™ H749389696610CATHETER, PERCUTANEOUS1 report
- RunWay™ H74938969680CATHETER, PERCUTANEOUS1 report
- RunWay™ H74938969710CATHETER, PERCUTANEOUS1 report
- RunWay™ H74938969686B0CATHETER, PERCUTANEOUS1 report
- RunWay™ H749389697140CATHETER, PERCUTANEOUS1 report
Recent RunWay adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionDec 3, 2024Fracture; Fracture
IT WAS REPORTED THAT THE TIP GOT FRACTURED. A RUNWAY CATHETER-GUIDE WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE DEVICE TIP GOT FRACTURED. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20833311 ↗MalfunctionOct 8, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
IT WAS REPORTED THAT A DEVICE SEPARATION OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND CALCIFIED ARTERY. A RUNWAY WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE TIP AND SHAFT SEPARATED AT BONDING. THERE WERE NO PATIENT COMPLICATIONS REPORTED POST PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20401962 ↗MalfunctionAug 14, 2024Fracture; Fracture
IT WAS REPORTED THAT THE TIP OF THE CATHETER WAS FRACTURED. THE 85% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED RIGHT CORONARY ARTERY. A MODEL-6F RUNWAY FR3.5 WAS SELECTED FOR CORONARY ANGIOPLASTY. DURING INTRODUCTION, THE DISTAL TIP OF THE CATHETER FRACTURED. THE DEVICE WAS REMOVED INTACT FROM THE PATIENT, AND A NEW RUNWAY CATHETER WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS IN EXCELLENT CONDITION FOLLOWING THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19988037 ↗MalfunctionJul 10, 2024Fracture; Fracture
IT WAS REPORTED THAT THE TIP OF THE CATHETER WAS BROKEN. A 6F RUNWAY CATHETER-GUIDE WAS SELECTED FOR USE. DURING PREPARATION, WHEN REMOVING THE CATHETER FROM THE PACKAGING, IT WAS NOTED THAT THE TIP WAS BROKEN. NO PATIENT COMPLICATIONS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19716344 ↗MalfunctionJul 5, 2024Break; Material Perforation; Break; Material Perforation
IT WAS REPORTED THAT THE SHAFT BROKE AND HAD A HOLE. A RUNWAY GUIDE CATHETER WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS REPORTED THAT THE SHAFT BROKE, AND A HOLE WAS ALSO NOTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19684688 ↗MalfunctionJun 28, 2024Break; Break
IT WAS REPORTED THAT A DEVICE FRACTURE OCCURRED. A RUNWAY CATHETER GUIDE WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE CATHETERS WERE RUPTURED AT THE TIME OF ENTRY INTO THE RADIAL ARTERY. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATIVE METHOD. THERE WERE NO PATIENT COMPLICATIONS REPORTED POST PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19638185 ↗MalfunctionJun 28, 2024Break; Break
IT WAS REPORTED THAT A DEVICE FRACTURE OCCURRED. A RUNWAY CATHETER GUIDE WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE CATHETERS WERE RUPTURED AT THE TIME OF ENTRY INTO THE RADIAL ARTERY. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATIVE METHOD. THERE WERE NO PATIENT COMPLICATIONS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19637918 ↗MalfunctionJun 30, 2023Fracture; Fracture
IT WAS REPORTED THAT DEVICE FRACTURE OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED CORONARY ARTERY. THE RUNWAY GUIDE CATHETER WAS SELECTED FOR USE IN A CORONARY ANGIOPLASTY PROCEDURE. DURING INSERTION, IT WAS NOTED THAT THE DISTAL PORTION OF THE DEVICE WAS FRACTURED. THE DEVICE WAS REMOVED INTACT FROM THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17240894 ↗MalfunctionJun 20, 2023Break; Break
IT WAS REPORTED THAT DEVICE DETACHMENT OCCURRED. A 6F RUNWAY GUIDE CATHETER WAS UNPACKED; HOWEVER, DEVICE WAS NOTED TO BE DAMAGED WITH BREAKAGES. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED, AND PATIENT'S STATUS WAS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17162331 ↗MalfunctionJun 13, 2023Break; Break
IT WAS REPORTED THAT DEVICE DETACHMENT OCCURRED. TWO 6F RUNWAY GUIDE CATHETERS WERE UNPACKED; HOWEVER, DEVICES WERE NOTED TO BE DAMAGED WITH BREAKAGES. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED, AND PATIENT'S STATUS WAS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17119336 ↗MalfunctionJun 13, 2023Break; Break
IT WAS REPORTED THAT DEVICE DETACHMENT OCCURRED. TWO 6F RUNWAY GUIDE CATHETERS WERE UNPACKED; HOWEVER, DEVICES WERE NOTED TO BE DAMAGED WITH BREAKAGES. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED, AND PATIENT'S STATUS WAS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17119335 ↗MalfunctionMay 30, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DEVICE FRACTURE OCCURRED. A 6F RUNWAY VL3.5 GUIDE CATHETER WAS SELECTED FOR USE. WHEN TAKING THE PRODUCT OUT OF THE PACKAGING, IT WAS OBSERVED THAT THE TIP OF THE CATHETER WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17026442 ↗MalfunctionApr 3, 2023Fracture; Fracture
IT WAS REPORTED THAT A TIP FRACTURE OCCURRED. A TIP FRACTURE WAS OBSERVED WHEN THE 6F RUNWAY GUIDE CATHETER WAS REMOVED FROM THE PACKAGE DURING PREPARATION. ANOTHER SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16662836 ↗DeathMar 1, 2023Break; Difficult to Remove; Difficult to Advance; Material Deformation; Adverse Event Without Identified Device or Use Problem; Break; Difficult to Remove; Difficult to Advance; Material Deformation; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT DEATH OCCURRED. A RUNWAY GUIDE CATHETER WAS SELECTED FOR USE. DURING THE PROCEDURE, WHEN THE CATHETER WAS BEING TORQUED TO ENGAGE THE CORONARY ARTERY, THE CATHETER BECAME TWISTED. AN ATTEMPT WAS MADE TO PASS A WIRE, BUT IT WAS UNSUCCESSFUL. AFTER SEVERAL MORE ATTEMPTS, THE PHYSICIAN PULLED THE KNOTTED GUIDE CATHETER ALONG WITH THE SHEATH THROUGH THE ARTERIOTOMY, BUT THE HUB OF THE CATHETER BECAME DETACHED, LEAVING THE REST OF THE GUIDE INSIDE THE PATIENT. AFTER AN ATTEMPT TO SNARE THE CATHETER FAILED, THE PATIENT WAS SENT TO COMPUTERIZED TOMOGRAPHY (CT) WHERE THEY PASSED AWAY DUE TO RETROPERITONEAL BLEED.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 16464370 ↗MalfunctionMay 16, 2022Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation
IT WAS REPORTED THAT CATHETER FRACTURE OCCURRED. THE PATIENT PRESENTED FOR LEFT CORONARY CATHETERIZATION. A RUNWAY GUIDE CATHETER WAS SELECTED FOR USE BUT DURING THE PROCEDURE, THERE WAS A CATHETER FRACTURE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14408175 ↗
Other Boston Scientific Corporation products
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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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