TURNPIKE IPN917515Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10841156108755), received between Jan 17, 2023 and Sep 17, 2024 — classified as 1 death, 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Separation” (5 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.

• 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 ↗
• 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 ↗
• InjuryNov 14, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT: OPERATOR WAS WORKING ON A HIGHLY CALCIFIED LESION. MULTIPLE ATTEMPTS WERE MADE TO REVASCULARIZE THE ANATOMY. MULTIPLE PRODUCTS, METHODS AND ACCESS POINT WERE ALL UNSUCCESSFUL. A SPIRAL WAS ATTEMPTED AND WHILE THE OPERATOR WAS WORKING WITH THAT DEVICE, THE TIP SEPARATED. ACCORDING TO THE NURSE LAB MANAGER, THE PHYSICIANS REPORT INDICATES "THE MICRO CATHETER DID BREAK, AND IT (THE TIP) WAS DECIDED TO BE INTENTIONALLY LEFT BEHIND. THIS WAS A VERY SMALL PIECE (APPROXIMATELY 5MM), LEFT IN AN OCCLUDED CALCIFIED ARTERY." ADDITIONAL INFORMATION: THE OPERATOR MENTIONED ROTATING BOTH CLOCKWISE AND COUNTERCLOCKWISE (TO OFFSET ANY TORQUE BUILD UP. NO STENTS WERE PLACED DURING THE PROCEDURE. THERE WAS NO REPORTED PATIENT HARM FROM THE INCIDENT. THEY ARE DUR TO RETURN FOR ANOTHER ATTEMPT AT ANGIOPLASTY.

  Patient problems: Foreign Body In Patient

  MAUDE report 18129173 ↗
• InjurySep 1, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT THE PHYSICIAN TRIED TO STENT THE RIGHT CORONARY ARTERY (RCA) AND THEN TRIED TO PUT THE TURNPIKE SPIRAL AND GUIDEWIRE INTO THE POSTEROLATERAL (PL) VESSEL, BUT THE SPIRAL TIP GOT STUCK IN NEW STENT. THE TIP OF THE CATHETER BROKE OFF AND WAS LEFT INSIDE THE PATIENT IN THE RCA AT THE BIFURCATION OF THE PL AND PATENT DUCTUS ARTERIOSUS (PDA) VESSELS. AS PER THE ADDITIONAL INFORMATION, THE CATHETER AND THE GUIDEWIRE WAS REMOVED FROM THE PATIENT AND THE SEPARATED TIP WAS STILL IN THE PATIENT. THE PATIENT WAS FINE POST PROCEDURE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 17670491 ↗
• MalfunctionJan 17, 2023Material Separation; Insufficient Device Problem Information; Material Separation; Insufficient Device Problem Information

  IT WAS REPORTED THAT: "TIP BROKE". ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE ACCOUNT.

  Patient problems: Insufficient Information

  MAUDE report 16184599 ↗