TURNPIKERecalls & reported problems across all models

We found 18 models of TURNPIKE by Teleflex Incorporated in the FDA's device registry (GUDID). Together they are named in 81 adverse event reports in the FDA's MAUDE database, received between May 2, 2019 and Feb 9, 2026 — classified as 5 deaths, 54 injuries, 22 malfunctions.

The most frequently reported specific device problem is “Material Separation” (27 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 TURNPIKE problems

TURNPIKE models

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

• TURNPIKE IPN039142

  Catheter, percutaneous
  1 death20 reports
• TURNPIKE IPN913578

  Catheter, percutaneous
  1 death18 reports
• TURNPIKE IPN039141

  Catheter, percutaneous
  1 death6 reports
• TURNPIKE IPN913577

  Catheter, percutaneous
  5 reports
• TURNPIKE IPN913580

  Catheter, percutaneous
  5 reports
• TURNPIKE IPN917515

  Catheter, percutaneous
  1 death5 reports
• TURNPIKE IPN913576

  Catheter, percutaneous
  3 reports
• TURNPIKE IPN917513

  Catheter, percutaneous
  1 death3 reports
• TURNPIKE IPN913579

  Catheter, percutaneous
  2 reports
• TURNPIKE IPN931271

  Catheter, percutaneous
  2 reports
• TURNPIKE IPN039140

  Catheter, percutaneous
  2 reports
• TURNPIKE IPN917514

  Catheter, percutaneous
  2 reports
• TURNPIKE IPN917517

  Catheter, percutaneous
  2 reports
• TURNPIKE IPN927570

  Catheter, percutaneous
  2 reports
• TURNPIKE IPN039144

  Catheter, percutaneous
  1 report
• TURNPIKE IPN039143

  Catheter, percutaneous
  1 report
• TURNPIKE IPN039138

  Catheter, percutaneous
  1 report
• TURNPIKE IPN927569

  Catheter, percutaneous
  1 report

Recent TURNPIKE adverse event reports

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

• InjuryFeb 9, 2026Material Separation

  IT WAS REPORTED THAT: "THE TIP OF THE CATHETER DISCONNECTED AND STAYED INSIDE THE PATIENT. THE TIP REMAINS IN THE PATIENT. THE PATIENT MUST NOW TAKE BLOOD THINNERS OR ANTITHROMBOTIC MEDICATION. THE PATIENT IS REPORTED AS "FINE".

  Patient problems: Foreign Body In Patient

  MAUDE report 24290020 ↗
• MalfunctionDec 3, 2025Difficult to Advance; Physical Resistance/Sticking; Difficult to Advance; Physical Resistance/Sticking

  IT WAS REPORTED THAT "TP SPIRAL USED WITH A GUIDEWIRE IN A CTO / COMPLEX CASE - SO ARTERIES NEEDED SOME WORK. DR SUSPECTED THERE WAS AN ISSUE WITH THE HUB. THE GUIDEWIRE GOT STUCK AND COULD NOT BE MOVED FORWARD THROUGH THE MICROCATHETER. THE DR TRIED TO MOVE IT, BUT IT LED TO A PERFORATION. PATIENT IS FINE. DR NOT SURE WHETHER THE TP SPIRAL WAS THE ISSUE BUT WANTED TO INVESTIGATE."

  Patient problems: Perforation

  MAUDE report 23704268 ↗
• InjuryOct 15, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT "TIP FRACTURE IN CTO CASE. THERE WAS NO REPORTED HARM OR HEALTH CONSEQUENCES TO THE PATIENT. PROCEDURE WAS A MULTI-VESSEL DISEASED, IN-STENT RESTENOSIS IN THE LAD CTO. THERE WAS A TIP FRACTURED THAT SEPARATED AND WAS LEFT IN THE DISTAL LAD."

  Patient problems: Foreign Body In Patient

  MAUDE report 23298766 ↗
• MalfunctionOct 9, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT: "TP SPIRAL WAS GUIDED TO THE STENOSIS UNDER IMAGING. DURING IMAGING, DR NOTICED THAT THE TIP BROKE OFF. THE TIP WAS TRAPPED IN THE LESION. DR INSERTED ANOTHER MICROCATHETER OVER THE TP SPIRAL AND WAS ABLE TO REMOVE EVERYTHING, INCLUDING THE GUIDE WIRE AND TP SPIRAL. A STENT WAS INSERTED. THE PATIENT WAS REPORTED AS FINE POST THE PROCEDURE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23252463 ↗
• InjurySep 29, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT: "DURING A PCI TO TREAT IN-STENT RESTENOSIS. THIS IS IN-STENT RESTENOSIS. THEREFORE, PREDILATION WITH A NON-COMPLIANT BALLOON FOLLOWED BY DRUG-COATED BALLOON. DUE TO DISTAL PERFORATION, IT WAS NECESSARY TO EMBOLIZE THE LEAK WITH COILS. THE FIRST MICROCATHETER WAS UNABLE TO PASS THROUGH THE FIRST OLD STENT. THIS IS WHY WE USED THE TURNPIKE INSTEAD. AT THE SAME LOCATION, THE TURNPIKE BECAME STUCK AND WOULD NOT ADVANCE ANY FURTHER. AFTER TWO CLOCKWISE TURNS, IT STILL WOULD NOT ADVANCE. WE DECIDED TO REMOVE THE MICROCATHETER AND PREDILATE THIS SECTION WHERE THE MICROCATHETERS WAS STUCK. WHEN WE REMOVED THE TURNPIKE, THE DISTAL TIP DETACHED AND REMAINED STUCK IN THE OLD STENT. SUBSEQUENTLY, JAILING OF THE BROKEN TIP WITH A NEW STENT. TOOK A NEW MICROCATHETER AND EMBOLIZATION OF 4X COILS TO OCCLUDE THE PERFORATION. IT TOOK SOME TIME TO JAIL THE LOST TIP, BUT ONCE IT WAS DONE, THE PATIENT WAS ABLE TO LEAVE THE CLINIC 48 HOURS LATER WITH NO SEQUELAE RELATED TO THE LOST TIP."

  Patient problems: Foreign Body In Patient

  MAUDE report 23165674 ↗
• InjurySep 8, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT: "CALCIFIED CX, TP SPIRAL WAS USED TO DELIVER OVER FLOPPY WIRE TO HELP WITH WIRE EXCHANGE AND THE TIP GOT STUCK IN THE CALCIUM AND SEPARATED FROM THE CATHETER. DR. WAS UNABLE TO SNARE THE DEVICE OR GET A WIRE NEXT TO THE TIP TO HELP REMOVE IT. 2MM OF THE TURNPIKE TIP REMAINED IN PATIENTS LEFT CIRCUMFLEX ARTERY. THE PATIENT WAS REPORTED AS FINE POST THE PROCEDURE."

  Patient problems: Foreign Body In Patient

  MAUDE report 22990305 ↗
• MalfunctionJul 23, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT: "BROKEN IN A VESSEL AND TOOK AN HOUR TO RETRIEVE." ADDITIONAL INFORMATION: "PHYSICIAN ADMITTED TO "OVERCLOCKING" AND STATED THAT HE DOESN'T BELIEVE IT WAS A PRODUCT FAILURE. TRAPLINER AND A BALLOON WERE USED TO MANEUVER AND RETRIEVE THE BROKEN TIP OF THE TURNPIKE SPIRAL."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22573795 ↗
• InjuryApr 30, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT: "DISTAL TIP OF TURNPIKE SPIRAL 135CM CATHETER DETACHED FROM THE CATHETER SHAFT AND LODGED IN CALCIUM LESION OF PATIENT'S RCA. TIP COULD NOT BE RETRIEVED BY PHYSICIAN, DR. (B)(6), AND THE BROKEN OFF TIP WAS TRAPPED AGAINST VESSEL WALL WITH A STENT. TURNPIKE SPIRAL WAS USED WITH A 6F R4 GUIDE AND OVER A 300CM WIRE. PATIENT WAS DISCHARGED, STABLE PER NURSE; NO CALLS OR ER VISITS POST PROCEDURE AND FOLLOW-UP WITH DR IN OFFICE IS PENDING."

  Patient problems: Foreign Body In Patient

  MAUDE report 21933423 ↗
• InjuryApr 30, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT: "TIP OF TP LP BROKE OFF IN CALCIFIED LAD.". ADDITIONAL INFORMATION RECEIVED ON 14APR2025: "THE TURNPIKE LP WITH A WIRE STUCK IN THE CATHETER MINUS THE TIP WAS DISCARDED. THE LAD WAS SEVERELY CALCIFIED WITH A MID CTO. THE LPS TIP WAS TRAPPED IN THE LAD CTO. I DIDN'T SEE HOW MANY TIMES THE DOCTOR TORQUED THE CATHETER PER IFU. THE TIP REMAINED IN THE CTO. THE REST OF THE TURNPIKE LP AND WIRE WERE REMOVED OUT OF THE BODY. ONLY A FEW MILLIMETERS OF THE TIP WERE BROKEN OFF IN THE CTO."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21932819 ↗
• InjuryDec 4, 2024Difficult to Remove; Material Separation; Difficult to Remove; Material Separation

  IT WAS REPORTED THAT: "MICROCATHETER WAS ADVANCED THROUGH CX THEN THROUGH EPICARDIAL FOR RETROGRADE PROCEDURE IN CTO. AFTER ENCOUNTERING SOME RESISTANCE AND MICROCATHETER SHOWING SOME SIGNS OF FATIGUE, OPERATOR ATTEMPTED TO REMOVE THE DEVICE. EVEN WITH PULL BACK AND TORQUING, DEVICE WAS NOT REMOVABLE. OPERATOR USED ROTABURR TO CUT THE DEVICE. NEEDS TO KNOW IF DEVICE IS MRI COMPATIBLE AS THEY WOULD LIKE TO RUN AN MRI ON THE PATIENT."

  Patient problems: Foreign Body In Patient

  MAUDE report 20840668 ↗
• DeathSep 17, 2024Material Separation; Material Separation

  IT WAS REPORTED BY THE DIRECTOR AT (B)(6) HOSPITAL, THAT DURING A CTO LAD LESION SURGERY: "LAD WAS VERY TIGHT. COULD NOT PASS 1.5MM BALLOON SO TRIED TO ADVANCE A TURNPIKE THROUGH THE LESION. IT'S BELIEVED THAT THE TURNPIKE TIP MOVEMENT WAS CONSTRICTED, AND THE TURNPIKE CONTINUED TO BE ROTATED MORE THAN 2 FULL 360 DEGREE ROTATIONS. APPROX. 2-3 MM OF THE TURNPIKE TIP BROKE OFF IN THE PATIENT. AFTER THE TIP BROKE OFF, I WAS TOLD A STINGRAY WAS USED TO GO SUBINTIMAL, AND AT SOME POINT, AFTER THAT THE PATIENT STARTED TO DECLINE. THE SEPARATED TIP OCCLUDED FLOW DOWN THE LAD LEADING TO ST ELEVATIONS ON TELEMETRY AND SIGNIFICANT PATIENT PAIN. THE PATIENT WENT INTO CARDIOGENIC SHOCK AND VENTRICULAR FIBRILLATION ABOUT 1-2 HOURS LATER. OFFERED SURGERY, BUT PATIENT'S FAMILY WAS ADAMANT THAT SHE DID NOT WANT SURGERY. WERE UNABLE TO REMOVE THE DEVICE AS IT WAS LODGED IN THE LAD LESION. WERE NOT ABLE TO WIRE AROUND THE DEVICE. TRIED DISSECTION AND RE-ENTRY AROUND THE LESION BUT WAS UNSUCCESSFUL. CAUSE OF DEATH: VENTRICULAR FIBRILLATION, MYOCARDIAL INFARCTION." ADDITIONAL INFORMATION QUOTED: CARDIOVASCULAR LAB NOTES SUPPLIED BY (B)(6) HOSPITAL TO TELEFLEX: "THE PATIENT WAS BROUGHT TO THE LAB FOR A

  Patient problems: Foreign Body In Patient

  MAUDE report 20234565 ↗
• MalfunctionAug 30, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT: "I AM REACHING OUT REGARDING A DAMAGED TELEFLEX PRODUCT (REF 5638). THIS PRODUCT WAS USED DURING A PATIENT PROCEDURE AND IT MALFUNCTIONED. " ADDITIONAL INFORMATION RECEIVED ON 19AUG2024: "I SPOKE WITH THE MANAGER SHE WAS IN THE CASE. SHE TOLD ME SHE DOES NOT HAVE THE "RESOURCES" TO RETRIEVE ALL THE DETAILS, BUT TOLD ME THAT IT WAS A VERY DIFFICULT CASE WITH A TIGHT LESION AND THE TURNPIKE SEEMED TO BE STUCK AND WHEN THEY TRIED TO MANEUVER THE CATHETER A PIECE OF THE TIP SEEMED TO DISLOCATE. THEY PLACED A WIRE NEXT TO THE MICROCATHETER AND WERE ABLE TO REMOVE EVERYTHING TOGETHER. NOTHING WAS LEFT BEHIND AND THEY WERE ABLE TO COMPLETE THE CASE USING ANOTHER TURNPIKE LP. THE PATIENT WAS REPORTED AS FINE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20105582 ↗
• MalfunctionAug 29, 2024Material Separation; Material Separation

  IT WAS REPORTED "TIP OF THE SPIRAL SNAPPED OFF AND DOCTOR WAS ABLE TO RETRIEVE IT IMMEDIATELY." THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20097736 ↗
• InjuryAug 28, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT "TURNPIKE SPIRAL BROKE OFF INSIDE PATIENT DURING PROCEDURE. " ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE CUSTOMER.

  Patient problems: Insufficient Information

  MAUDE report 20083584 ↗
• MalfunctionAug 9, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT: "I WAS RETROGRADE THROUGH A SEPTAL COLLATERAL INTO THE DISTAL RCA. THE TURNPIKE STALLED. I TRIED TO REMOVE THE CATHETER AND REALIZED THE SHAFT HAD BROKEN APPROXIMATELY 12CM FROM THE TIP. I WAS ABLE TO RETRIEVE THE BROKEN DEVICE. NO HARM CAME TO THE PATIENT. THE BROKEN DEVICE WAS SENT TO SUPPLY TO ESCALATE THE INCIDENT."ADDITIONAL INFORMATION: "TURNPIKE STALLED IT WASN'T STUCK. I WAS RETROGRADE THROUGH A LAD SEPTAL INTO DISTAL RCA WITH TP. PILOT 200 WIRE KNUCKLED THROUGH TP INTO MID RCA. SHAFT SEPARATED ABOUT 12CM FROM TIP. I WAS ABLE TO TRAP THE DISTAL SHAFT WITH A BALLOON IN A GUIDLINER PASSED ON A SEPARATE WIRE."

  Patient problems: Foreign Body In Patient

  MAUDE report 19952563 ↗

Other Teleflex Incorporated products

• ARROW1,494 models · 9,043 reports · 62 recalls
• RUSCH220 models · 436 reports · 130 recalls
• WECK97 models · 3,790 reports · 1 recall
• HUDSON RCI152 models · 1,461 reports · 7 recalls
• LANGSTON4 models · 15 reports · 5 recalls
• PLEUR-EVAC15 models · 146 reports · 1 recall
• LMA AIRWAY MANAGEMENT47 models · 139 reports
• UROLIFT13 models · 137 reports