TURNPIKE IPN917513Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10841156108731), received between Dec 6, 2022 and Aug 30, 2024 — classified as 1 death, 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Material Separation” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• InjuryMar 25, 2024

  PATIENT PLACED ON TABLE AND PROCDURE STARTED SOON AFTER. BMW WIRE INSERTED THEN TURNPIKE WAS INSERTED. TURNPIKE WAS REMOVED SOON AFTER. TIP ON TURNPIKE WAS RETAINED IN VESSEL; NOTED ON FLUOROSCOPY.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 18967783 ↗
• DeathDec 6, 2022Separation Problem; Separation Problem

  IT WAS REPORTED THAT: THE TIP OF TURNPIKE SEPARATED ONTO WIRE. WIRE WOULD NOT COME OUT OF GUIDE. GUIDE AND WIRE REMOVED TOGETHER. TIP OF TURNPIKE LP REMAINS ON WIRE. ADDITIONAL INFORMATION REPORTED ON 11NOV2022: THE ENTIRE TURNPIKE AND TIP WERE REMOVED FROM THE VESSEL AFTER TIP SEPARATION. THE PHYSICIAN THEN COMPLETED THE PROCEDURE. THE PATIENT CODED IN RECOVERY. DATE OF DEATH (B)(6) 2022. THERE WERE NO ISSUES IN THE LAB WITH THE PATIENT AS FAR AS HEMODYNAMICS, PAIN, ETC. THE PHYSICIAN REPORTED THAT HE DOES NOT BELIEVE THE TIP SEPARATION HAD ANYTHING TO DO WITH THE EXPIRATION OF THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 15924584 ↗