TURNPIKE IPN913577Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10841156100698), received between Oct 27, 2020 and Oct 15, 2025 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Material Separation” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• MalfunctionMar 8, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT "TURNPIKE LP WAS USED IN THE HOSPITAL IN ZWOLLE THE NETHERLANDS ON 7 FEBRUARY 2024 DURING A CTO. DURING RETRACTING AFTER SPINNING THE DEVICE IN A CORONARY ARTERY (INTENDED USE BY EXPERIENCED OPERATOR) THE TURNPIKE LP BROKE DOWN IN 2 PIECES. CATHETER FRACTURE AT 20 CM FROM THE DISTAL TIP. CATHETER WAS RETRACTED, FRACTURED PIECE WAS RETRACTED WITH SNARING TECHNIQUE ( EN SNARE FROM MERIT MEDICAL). AFTER ASKING: NO NEGATIVE EFFECT ON PATIENT OR OUTCOME, BUT PROCEDURE LASTED LONGER." ADDITIONAL INFORMATION: TURNPIKE LP WAS USED IN RETROGRADE CASE, FROM LAD TO RCA VIA SEPTAL CHANNEL. IT BROKE AFTER EXTENSIVE TORQUEING AND PUSHING IN A VERY DIFFICULT CASE. IT WAS CUT "CLEAN" DURING A 90 DEGREE BEND WHERE THERE WAS EXTENSIVE CALCIUM UNDER AND ABOVE THE BEND OF 90 DEGREES FROM LAD TO SEPTAL. BOTH DOCTORS ALSO NOTED MULTIPLE SCRATCHES ON THE TURNPIKE PROXIMAL OF THE TURNPIKE LP LEISURE. PATIENT HAD TWO PREVIOUS EVENTS WITH BROKEN MATERIAL FROM A DIFFERENT SUPPLIER IN PREVIOUS CASES IN THE RIGHT ARM AND ONE IN THE RCA. WHEN THE TURNPIKE BROKE DOCTORS FELT NO RESISTANCE AND TOOK OUT PROXIMAL PART, BUT ONLY MEASURED 130 CM. DISTAL 20 CM WAS RETRIEVED BY USING A SNARE, WHICH

  Patient problems: Foreign Body In Patient; Vascular Dissection

  MAUDE report 18864598 ↗
• InjuryFeb 13, 2024Difficult to Remove; Material Separation; Difficult to Remove; Material Separation

  IT WAS REPORTED THAT: DR. WAS PERFORMING A LM, LCX CTO. HE WAS USING THE TURNPIKE LP RETROGRADE OVER A MONGO WIRE TO THE MID-LCX AND HE SAID IT FATIGUED AND HE TRIED TO REMOVE IT OVER THE MONGO WIRE AND IT WOULD BUDGE, IT WAS STUCK AROUND THE BENDY PART OF THE LCX, HE TRIED TO WALK IT OUT AND NOTHING MOVED. HE TRIED TO TUG ON IT AND NOTHING MOVED, HE TRIED TO EXCHANGE THE WIRE FOR ANOTHER MONGO AND THAT DID NOT HELP WITH BACKING OUT THE SYSTEM HE ADDED AN EXTENSION WIRE TO THE MONGO WIRE AND THEN LOST THE WIRE, SO HE HAD TO CUT THE TURNPIKE TO FIND THE WIRE TO REMOVE IT. HE IS ESTIMATING 15CM OF CATHETER HAS BEEN LEFT IN THE PATIENT'S VESSEL , BUT HE DID NOT PERF THE VESSEL NOR DID IT CAUSE AN MI. PATIENT WAS REPORTED AS FINE.

  Patient problems: Foreign Body In Patient

  MAUDE report 18694516 ↗
• InjuryOct 27, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED: TIP SEPARATED, FELL APART IN USE. STENTED THE TIP TO THE VESSEL WALL. IT IS REPORTED IT WAS A SUCCESSFUL CTO- VESSEL OPENED.

  Patient problems: Foreign Body In Patient

  MAUDE report 10743681 ↗