TURNPIKE IPN913578Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 10841156100704), received between May 2, 2019 and Oct 9, 2025 — classified as 1 death, 9 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Material Separation” (9 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• 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 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 ↗
• 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 ↗
• InjuryJun 10, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT: "PHYSICIAN WAS PERFORMING A CTO PROCEDURE AND WAS USING THE TP SPIRAL FOR CROSSING THE LESION IN AN ANTEGRADE DIRECTION. THE LESION WAS LOCATED IN THE CX. AT SOME POINT DURING THE CASE, THE TIP OF THE TP SPIRAL SEPARATED FROM THE DEVICE. THEY DID NOT NOTICE UNTIL THEY PROCEEDED WITH BALLOON ON THE LESION THAT A SMALL PORTION OF THE RADIOPAQUE TIP HAD BROKEN OFF IN THE LESION, NOT THE ENTIRE TIP. ATTEMPTS TO RETRIEVE THE BROKEN TIP WERE NOT SUCCESSFUL AND THE TIP BECAME LODGED IN THE PLV. THE CTO WAS SUCCESSFULLY CROSSED AND OPENED, AFTER CROSSING THE LESION, THEY EXCHANGED WIRES FOR ADDITIONAL SUPPORT. PATIENT IS DOING WELL. DISCUSSIONS WITH BRINGING THE PATIENT BACK TO RETRIEVE THE BROKEN TIP WERE HAD WITH THE FAMILY AND THE DECISION WAS MADE NOT TO PROCEED WITH ANY ADDITIONAL SURGERY."

  Patient problems: Foreign Body In Patient

  MAUDE report 19498407 ↗
• DeathApr 11, 2024Material Separation; Material Separation

  IT WAS REPORTED BY CLINICAL STAFF AT THE HOSPITAL THAT: PATIENT HAD A "HEAVILY CALCIFIED LAD VESSEL. TURNPIKE SPIRAL TIP BROKE DURING PROCEDURE. UNABLE TO RETRIEVE." THE PATIENT'S CURRENT CONDITION IS REPORTED BY STAFF AT THE HOSPITAL AS DECEASED. THE PROCEDURE WAS REPORTED BY CLINICAL STAFF AT THE HOSPITAL TO BE A PLANNED PCI LAD ROTABLATION.ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE HOSPITAL.

  Patient problems: Foreign Body In Patient

  MAUDE report 19087861 ↗
• MalfunctionJan 3, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT: TIP OF CATHETER DISENGAGED WITH THE SHAFT WHILST IN THE CORONARY ARTERY. ADDITIONAL INFORMATION: THE DEVICE WAS REMOVED, AND THE PROCEDURE CONTINUED. THE PROCEDURE WAS ULTIMATELY SUCCESSFUL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18433758 ↗
• InjuryAug 25, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT: ON 14/07/2023 DR PERFORMED A COMPLEX OCCLUSION PROCEDURE ON RCA(RIGHT CORONARY ARTERY). AFTER CROSSING THE STENOSIS WITH GUIDEWIRE, HE DECIDED TO INSERT A TURNPIKE SPIRAL ON THE PROXIMAL LESION. AFTER FEW ATTEMPTS THERE WAS A PARTIAL TIP FRACTURE. ADDITIONAL INFORMATION: ISSUE RESOLVED: PARTIAL TIP OF MICROCATHETER REMAINED IN TARGET LESION AND IT WAS PUSHED TO VESSEL WALL USING STENT CRUSHING; THE USE OF STENT IN THE SEGMENT WAS PLANNED BEFORE DUE TO SEVERE STENOSIS OF THE RCA. THE PATIENTS CLINICAL STATUS WAS REPORTED AS FINE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 17621921 ↗
• MalfunctionFeb 18, 2021No Apparent Adverse Event; No Apparent Adverse Event

  AS REPORTED: PHYSICIAN FOUND THAT THE PRODUCT FAILED TO ADVANCE THE LESION AND CLOSED THE PROCEDURE USING OTHER'S PRODUCT. SAMPLE WAS RETURNED FOR INVESTIGATION, AND DURING INVESTIGATION ON (B)(6) 2021 IT WAS FOUND THAT THE TIP WAS SEVERELY DAMAGED, AND LITTLE SLIVERS OF THE TIP WERE MISSING. THE TIP WAS STILL ATTACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11345479 ↗
• MalfunctionOct 16, 2020Material Fragmentation; Material Fragmentation

  AS REPORTED: THE TURNPIKE SPIRAL WAS ADVANCED AFTER A TURNPIKE LP WAS PASSED THROUGH A MILDLY CALCIFIED RCA. AFTER THE LP PASSED THROUGH THE VESSEL, A TURNPIKE SPIRAL WAS ADVANCED TO ENLARGE THE CHANNEL CREATED BY THE LP. THE SPIRAL STALLED AND THE DOCTOR DID NOT PUSH THE TURNPIKE SPIRAL AND INSTEAD REMOVED IT TO USE THE LP AGAIN. WHEN HE DID THIS HE SAW THE TIP HAD COME OFF THE SPIRAL. UNSUCCESSFUL ATTEMPTS HAVE BEEN MADE TO REQUEST HOW THE TIP WAS REMOVED. PROCEDURE WAS ABORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10689004 ↗
• InjuryJun 25, 2020Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THERE WAS A PERIPHERAL PTA ATHERECTOMY. IT WAS NOTED THAT THE DISTAL TIP OF THE TURNPIKE SPIRAL BROKE OFF IN THE MID POSTERIOR TIB ARTERY, WHICH IS HEAVILY CALCIFIED. SNARING ATTEMPTS TO RETRIEVE WERE UNSUCCESSFUL. IT IS REPORTED THE PATIENT (WHO IS STABLE AND DOING WELL) WILL COME BACK IN ATTEMPT TO REMOVE LATER. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Vessel Or Plaque, Device Embedded In

  MAUDE report 10195281 ↗
• InjuryOct 31, 2019Material Fragmentation; Material Fragmentation

  PHYSICIAN WAS PASSING A WIRE DOWN A CALCIFIED LAD DURING A PCI. HE WAS USING A WIRE AND A TURNPIKE SPIRAL. WHEN HE WAS ATTEMPTING TO MANEUVER THE TURNPIKE SPIRAL IT WAS DIFFICULT SINCE IT WAS A CTO, AND A LITTLE RESISTANCE WAS FELT. DURING ADVANCEMENT OF THE WIRE, IT WAS BUCKLING BACK. HOWEVER, THE WIRE MOTION WAS FREE IN THE TURNPIKE THROUGHOUT THE PROCEDURE. HE THEN MOVED THE TURNPIKE SPIRAL BACK OUT OF THE VESSEL AND NOTICED THAT THE TIP REMAINED WITHIN THE LAD. THE TIP AND THE DEVICE WERE REMOVED SUCCESSFULLY FROM THE PATIENT THROUGH A 7FR GUIDELINER. OUTCOME OF THE PATIENT WAS A SUCCESSFUL PCI. THERE WAS NO PATIENT INJURY REPORTED IN THIS CASE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9262358 ↗
• InjuryOct 31, 2019Material Fragmentation; Material Fragmentation

  PHYSICIAN WAS DOING A CTO AND THE TIP OF THE TURNPIKE SPIRAL CATHETER BROKE OFF IN A TIGHT RCA LESION. THE TIP WAS LEFT IN THE PATIENT AND IS BETWEEN THE STENT AND THE VESSEL WALL. RESISTANCE FELT DURING PROCEDURE WAS DUE TO TIGHT LESION. OUTCOME OF PATIENT IS STABLE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9262089 ↗
• MalfunctionAug 2, 2019Unraveled Material; Unraveled Material

  PHYSICIAN WAS DOING A PCI WITH OUR TURNPIKE SPIRAL 135CM CATHETER. THE CATHETER TIP UNRAVELED AND WAS PULLED OUT, NO HARM TO PATIENT, THEY USED A MICROCATHETER TO CONTINUE THE CASE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8856075 ↗
• InjuryJul 18, 2019Material Fragmentation; Material Fragmentation

  MID LAD LESION WITH TORTUOSITY. TURNPIKE SPIRAL WAS USED 5 TIMES WITH 15 SPINS, BOTH CLOCKWISE TO ADVANCE, AND COUNTER-CLOCKWISE TO REMOVE. TIP OF THE MICRO-CATHETER BROKE OFF AND WAS LODGED IN ARTERY. SEVERAL HOURS WERE SPENT TO RETRIEVE TIP BUT WAS UNSUCCESSFUL. PATIENT WAS SENT FOR BYPASS SURGERY. PATIENT IS STABLE AS OF (B)(6) 2019. WHEN WE HAVE FURTHER INFORMATION, WE WILL DECIDE ABOUT RELEASING THE CATHETER.

  Patient problems: Vessel Or Plaque, Device Embedded In

  MAUDE report 8805395 ↗
• MalfunctionMay 7, 2019Separation Problem; Separation Problem

  DURING USE ON PATIENT, TIP BROKE OFF INSIDE THE CORONARY OF THE PATIENT. THE PIECE WAS REMOVED FROM THE PATIENT. IT WAS OBSERVED THAT THE PIECE WAS STUCK ON THE GUIDEWIRE. IT WAS IMPOSSIBLE TO SEPARATE THEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8588216 ↗
• InjuryMay 2, 2019Separation Problem; Separation Problem

  TURNPIKE SPIRAL BROKE DURING PROCEDURE. ADDITIONAL INFORMATION RECEIVED 18APR19: PT RETURNS FOR HIGH RISK PCI OF COMPLEX, CALCIFIED, DIFFUSELY DISEASED RCA. A 8F GUIDE WAS ADVANCED TO THE RCA OSTIUM FROM THE RIGHT FEMORAL ARTERY AND A BALLOON-TIPPED PACING WIRE WAS ADVANCED TO THE RV APEX FROM THE RIGHT FEMORAL VEIN. THE COMPLEX MID LESION WAS CROSSED WITH A GUIDEWIRE (AFTER ATTEMPTING WITH A PREVIOUS WIRE) BUT A TURNPIKE SPIRAL WOULD NOT CROSS DESPITE SUPPORT OF A 8F TRAPLINER. DECISION MADE TO WITHDRAW THE TRAPLINER AND BALLOON THE PROXIMAL VESSEL TO ALLOW FOR MORE DISTAL PLACEMENT OF THE GUIDELINER. UPON WITHDRAWAL OF THE TURNPIKE SPIRAL, THE TIP OF THE CATHETER FRACTURED IN THE LESION. THE REMAINDER OF THE CATHETER WAS WITHDRAWN. NEXT, LIMITED ATTEMPTS MADE TO WIRE THE VESSEL WITH ANOTHER GUIDEWIRE WAS UNSUCCESSFUL, BUT THE PROXIMAL DISEASE WAS BALLOONED WITH A 3.0X15MM NC BALLOON AND UPON WITHDRAWAL OF THE BALLOON, THE DISLODGED CATHETER TIP WAS DRAGGED BACK INTO THE GUIDELINER. DECISION MADE TO TRAP THE CATHETER TIP IN THE GUIDELINER WITH A 2.OMM BALLOON AND WITHDRAW EVERYTHING THROUGH THE GUIDE., ACCESS HAD BEEN OBTAINED IN THE CONTRALATERAL GROIN TO ALLOW FOR VISUALIZATION

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8575006 ↗