Turnpike® catheter 5642Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI M20656420), received between Jan 12, 2017 and Apr 2, 2019 — classified as 3 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryApr 2, 2019Separation Problem; Separation Problem

  PATIENT WAS RECEIVED IN THE CATH LAB WITH ARRYTHMIA-VT AND CHEST PAIN. PHYSICIAN ATTEMPTED TO OPEN AN LAD LESION THAT WAS SUSPECTED TO BE HEAVY CALCIFIED AND A COMPLEX CASE. THE PHYSICIAN MET RESISTANCE IN THE VESSEL RIGHT AWAY BUT KEPT TORQUING THE CATHETER WITHOUT RELEASING. PHYSICIAN REALIZED THE CATHETER WASN'T ADVANCING ANYMORE AND TRIED TO REMOVE THE GUIDEWIRE WITH THE TURNPIKE CATHETER, WHEN A SMALL PIECE OF THE TIP OF THE CATHETER DETACHED FROM THE WIRE. THE PHYSICIAN DIDN'T SNARE OR TRY TO REMOVE THE PIECE OF THE TIP. THE TURNPIKE CATHETER WAS SUCCESSFULLY RETRIEVED. THEY CANCELLED THE INTERVENTION. PHYSICIAN AND STAFF INFORMED ME THE PATIENT IS DOING WELL AND DID NOT HAVE A MAJOR ADVERSE EVENT. THE PHYSICIAN STATED, THE FAMILY OF TURNPIKE CATHETERS PROBABLY WASN'T THE RIGHT CATHETER FOR THAT SPECIFIC LESION. ADDITIONAL INFORMATION RECEIVED 11MAR19: THE TIP OF THE TURNPIKE DETACHED, AND THE GUIDEWIRE WAS FINE AFTER IT WAS RETRIEVED. THE PHYSICIAN DIDN'T PERFORM ANY PROCEDURES TO REMOVE THE PIECE OF THE TIP OF THE CATHETER LEFT BEHIND IN THE ARTERY, AND THE TIP IS IN THE MID DISTAL LAD VESSEL. THE PATIENT IS STABLE POST PROCEDURE AND NO FURTHER INTERVENTIONS WERE REQUIRED.

  Patient problems: Vessel Or Plaque, Device Embedded In

  MAUDE report 8472746 ↗
• MalfunctionOct 30, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  THE DEVICE WASN'T TESTED BEFORE USE. THIS WAS A CTO PROCEDURE OF THE RCA, SO WAS COMPLICATED, AND THERE WAS CALCIUM WITHIN THE VESSEL. DURING USE ON PATIENT, TIP BROKE OFF, AND HAD TO BE REMOVED. THE TIP BROKE OFF ON THE WIRE, SO THE WHOLE WIRE HAD TO COME OUT AND BE REPLACED BY ANOTHER ONE. NO ADVERSE INJURY TO PATIENT. THE UNIT WAS DISCARDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8019921 ↗
• InjurySep 27, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  DURING A HEAVILY CALCIFIED LESION IN THE LAD, A TURNPIKE CATHETER WAS USED TO FACILITATE WIRE EXCHANGE. A WIRE WAS ADVANCE PASSED THE LESION AND THE TURNPIKE WAS LOADED ON THE WIRE BUT WAS UNABLE TO BE SPUN PASSED THE LESION. WHEN THE TURNPIKE WAS REMOVED, IT WAS NOTICED THAT THERE WAS SOMETHING STILL ON THE WIRE. A SECOND WIRE WAS PLACED DOWN THE VESSEL AND THE ORIGINAL WIRE WAS REMOVED WITH THE MATERIAL STILL ATTACHED. THE CASE WAS COMPLETED WITH GOOD RESULTS USING ROTABLATOR. ADDITIONAL INFORMATION RECEIVED VIA PHONE CALL RECEIVED WHICH REPORTED THE TIP DETACHED, HOWEVER, STAYED ON WIRE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7913832 ↗
• MalfunctionJul 27, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  CHRONIC TOTAL OCCLUSION ON RIGHT CORONARY ARTERY: CATHETER DISTAL TIP BROKEN IN CALCIFICATION IN RCA (RIGHT CORONARY ARTERY). A PIECE OF THE CATHETER REMAINED STUCK IN THE CALCIFIED PART OF THE RCA." CLINICAL CONSEQUENCES : "NO CONSEQUENCE FOR THE PATIENT BUT THE CORONARY OCCLUSION PROCEDURE FAILED."THERE WAS NO PATIENT INJURY. IT DOES NOT MATTER THAT A PIECE IS STILL IN THE PATIENT BECAUSE THE PIECE IS STUCK IN THE "CALCIFICATION" OF THE ARTERY. CURRENT PATIENT CONDITION REPORTED AS "FINE" NO PATIENT INJURY OR IMPACT REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7726429 ↗
• InjuryJan 26, 2017Detachment Of Device Component; Material Fragmentation; Detachment Of Device Component; Material Fragmentation

  DIFFICULT CTO IN THE DISTAL POSTERIOR LATERAL VESSEL. VERY TORTUOUS VESSEL WITH A STENT ON A TURN. TURNPIKE WAS ADVANCED ON A WIRE, TURNPIKE WAS TORQUED OVER 100 TIMES AND THEY BELIEVE THAT THE TURNPIKE TIP GOT WEDGED/STUCK ON A STENT STRUT WHICH CAUSED THE TIP TO SEPARATE FROM THE CATHETER. THE TIP WAS REMOVED FROM THE BODY ON THE WIRE. NO PATIENT IMPACT REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6280544 ↗
• MalfunctionJan 12, 2017Detachment Of Device Component; Detachment Of Device Component

  THE TIP BROKE OFF INSIDE PATIENT DURING PROCEDURE, BUT IT HAS BEEN RETRIEVED. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6245742 ↗