RunWay™ H749389695740Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 08714729478386), received between Oct 18, 2018 and Nov 16, 2021 — classified as 2 deaths, 6 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 18, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 16, 2021Fracture; Adverse Event Without Identified Device or Use Problem; Fracture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FRACTURED CATHETER OCCURED. A RUNWAY GUIDING CATHETER WAS SELECTED FOR TREATMENT. HOWEVER, A FRACTURED CATHETER WAS OBSERVED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12823590 ↗
• MalfunctionJan 6, 2021Break; Break

  IT WAS REPORTED THAT CATHETER BREAK OCCURRED. THE TARGET VESSEL WAS LOCATED IN CORONARY ARTERY. A RUNWAY GUIDE CATHETER WAS SELECTED FOR CORONARY ANGIOPLASTY. DURING PREPARATION, THE GUIDE CATHETER BROKE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 11123931 ↗
• DeathOct 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA MEDWATCH (B)(4) THAT DEATH OCCURRED. THE PATIENT PRESENTED WITH RECENT THREE VEIN GRAFT HEART SURGERY WHICH HAD DAMAGED THE LEFT ANTERIOR DESCENDING ARTERY (LAD) DISTAL TO THE ATTACHMENT OF THE VEIN GRAFT. THE DAMAGE WAS REPAIRED IN THE OPERATING ROOM BUT THE ARTERY LIKELY CLOSED THE NIGHT OF THE SURGERY. THE PATIENT WAS NOTED TO BE HEMODYNAMICALLY UNSTABLE WITH VENTRICULAR TACHYCARDIA AND WITH ELECTROCARDIOGRAM CHANGES SUGGESTIVE OF A CARDIAC INFARCTION. THE PATIENT WAS TAKEN EMERGENTLY TO THE CATHERIZATION LAB. DURING THE PROCEDURE, A MODEL-6F RUNWAY CLS3.5 GUIDE CATHETER WAS IN USE. THE LAD DISTAL TO THE FRESHLY PLACED GRAFT WAS OCCLUDED;100% STENOSED IN THE MIDDLE LAD AND 70% STENOSED IN THE PROXIMAL LAD. THE PHYSICIAN TRIED OPENING THE OCCLUDED SEGMENT WITH A BALLOON, BUT THE RESULT WAS SUBOPTIMAL, AND PLACEMENT OF A STENT WAS THEN DECIDED AS THE BEST OPTION AT THAT TIME. WHEN THE PHYSICIAN PLACED A 2.25MM STENT, THE REPAIRED PORTION OF THE LAD WAS LIKELY PERFORATED BY THE GRAFT STITCHING COMING LOOSE. THE PHYSICIAN OCCLUDED THE SITE WITH A BALLOON AND DECIDED TO PLACE A COVERED STENT AS A LAST RESORT. THE SMALLEST COVERED STENT WAS 2.5MM BUT THERE WAS NO O

  Patient problems: Death

  MAUDE report 10650663 ↗
• DeathSep 1, 2020Activation, Positioning or Separation Problem

  FROM STAFF: DURING CORONARY INTERVENTION A STENT WAS DEPLOYED CAUSING A TEAR IN THE VESSEL. WE ATTEMPTED THE DELIVERY OF A PK PAPYRUS STENT HOWEVER WERE UNSUCCESSFUL. UPON REMOVAL OF THE PAPYRUS THE COVERED PORTION OF THE STENT WAS NOT PRESENT ON THE STENT. UPON FURTHER INVESTIGATION IT IS BELIEVED TO HAVE FALLEN OFF INTO THE PATIENT'S CORONARY VESSEL WITHOUT BEING DEPLOYED. THUS, MADE FURTHER INTERVENTION IMPOSSIBLE TO HAPPEN DUE TO INABILITY TO PASS THE EQUIPMENT. FROM DOCTOR: PATIENT WAS RECENTLY POST CARDIAC SURGERY WITH 3 VEIN GRAFTS PLACED TO HER HEART ARTERIES, DURING SURGERY THERE WAS DAMAGE TO THE LEFT ANTERIOR DESCENDING (LAD), WHICH WAS REPAIRED IN THE OR DISTAL TO THE ATTACHMENT OF THE VEIN GRAFT. THE ARTERY DID NOT STAY OPEN AND CLOSED LIKELY THE NIGHT OF THE SURGERY, THE PATIENT WAS NOTED TO BE HEMODYNAMICALLY UNSTABLE AND WITH VENTRICULAR TACHYCARDIA AND WITH ELECTROCARDIOGRAM CHANGES SUGGESTIVE OF A CARDIAC INFARCTION. WE TOOK THE PATIENT EMERGENTLY TO THE CATHERIZATION LAB AND NOTED THAT THE LAD SEGMENT DISTAL TO THE FRESHLY PLACED GRAFT WAS OCCLUDED, WE TRIED OPENING THE SEGMENT WITH A BALLOON, BUT THE RESULT WAS SUBOPTIMAL, AND PLACEMENT OF A STENT WAS THEN DECID

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10476349 ↗
• MalfunctionJun 4, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED. A 2.25 X 20MM SYNERGY DRUG-ELUTING STENT AND 2 MODEL-6F CLS3.5 RUNWAY GUIDE CATHETERS WERE USED FOR TREATMENT. POST SEDATION PRIOR TO USE, IT WAS NOTED THAT THE GUIDE CATHETER DID NOT RETAIN ITS SHAPE, ANOTHER DEVICE WAS OPENED AND HAD THE SAME ISSUE. THE STENT WAS ADVANCED MULTIPLE TIMES BUT FAILED TO CROSS THE LESION. THE STENT WAS REMOVED AND THE PROCEDURE WAS NOT COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10120302 ↗
• MalfunctionJun 4, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED. A 2.25 X 20MM SYNERGY DRUG-ELUTING STENT AND 2 MODEL-6F CLS3.5 RUNWAY GUIDE CATHETERS WERE USED FOR TREATMENT. POST SEDATION PRIOR TO USE, IT WAS NOTED THAT THE GUIDE CATHETER DID NOT RETAIN ITS SHAPE, ANOTHER DEVICE WAS OPENED AND HAD THE SAME ISSUE. THE STENT WAS ADVANCED MULTIPLE TIMES BUT FAILED TO CROSS THE LESION. THE STENT WAS REMOVED AND THE PROCEDURE WAS NOT COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT WAS STABLE. IT WAS FURTHER REPORTED THAT THE PHYSICIAN USED A GUIDELINER AND MANAGED TO TREAT THE PATIENT, AND THE PROCEDURE WAS COMPLETED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10120284 ↗
• MalfunctionJun 10, 2019Break; Break

  IT WAS REPORTED THAT CATHETER BREAK OCCURRED. THE TARGET VESSEL WAS LOCATED IN CORONARY ARTERY. A RUNWAY GUIDE CATHETER WAS SELECTED FOR USE. DURING PREPARATION, WHEN THE GUIDE CATHETER WAS FROM THE PACKAGE, IT WAS OBSERVED TO BE BROKEN. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8683462 ↗
• MalfunctionOct 18, 2018Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MILDLY CALCIFIED ARTERY. A 6F RUNWAY GUIDE CATHETER WAS SELECTED FOR USE. HOWEVER, WHEN THE GUIDING CATHETER WAS TRIED TO INSERT DURING ACUTE MYOCARDIAL INFARCTION CASE, IT WAS NOTED THAT THE SECOND CURVE GOT KINKED/BROKEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7981048 ↗