TURNPIKE IPN917517Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10841156108779), received between Aug 18, 2022 and May 8, 2023 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Break” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMay 8, 2023Fracture; Fracture

  IT WAS REPORTED THAT: WE HAD AN ISSUE YESTERDAY WITH A TURNPIKE TIP FRACTURING IN THE PATIENTS DIAG ARTERY. WHEN IT WAS FINALLY RETRIEVED , IT WAS BOUND TO THE WIRE. ADDITIONAL INFORMATION: THE ABOVE ISSUE OCCURRED DURING A PCI PROCEDURE ON THE (B)(6) 2023, THE PATIENT SUFFERED A DISRUPTION OF THE LAD & IMPAIRED FLOW TO THE LAD PER MD'S NOTE. TO FIX THIS, MD NEEDED TO STENT LAD AND DIAGONAL. THE TURNPIKE WAS REMOVED IN ITS ENTIRETY. THE PATIENT'S VESSELS WERE DESCRIBED AS CALCIFIED. POST PROCEDURE THE PATIENT'S CONDITION WAS REPORTED AS STABLE, THEY WERE SENT TO ICU, THEN DISCHARGED HOME FROM THERE.

  Patient problems: Obstruction/Occlusion; Reduced Blood Flow

  MAUDE report 16884404 ↗
• MalfunctionAug 18, 2022Break; Insufficient Device Problem Information; Break; Insufficient Device Problem Information

  AS REPORTED: COMPLETE TIP SEPARATION. WHEN THE TURNPIKE SMOOTH WAS ADVANCED, AND THE PHYSICIAN STARTED ADVANCING IN A CLOCKWISE MOTION THE ENTIRE TIP IMMEDIATELY SEPARATED WITH VERY LITTLE RESISTANCE. HE SAID IT DIDN'T FEEL RIGHT, AND UPON REMOVAL FOR INSPECTION THE TIP WAS ALREADY SEPARATED AND DETACHED. THE TIP WAS LEFT IN, AND ANOTHER GUIDEWIRE WAS UNABLE TO CROSS. THE TIP WAS NOT ABLE TO BE RETRIEVED. ADDITIONAL INFORMATION ON 05AUG2022: THE ENTIRE TIP OF THE TURNPIKE SMOOTH CAME OFF AND IT WAS NOT RETRIEVABLE AND REMAINS IN THE VESSEL. IT WAS REPORTED THAT THERE WAS A CLEAR CHANNEL AND THE PHYSICIAN EXPERIENCED LITTLE RESISTANCE ADVANCING THE CATHETER. AN ANGIOGRAM WAS SUBMITTED FOR INVESTIGATION. PATIENT'S CURRENT CONDITION IS REPORTED AS FINE.

  Patient problems: Foreign Body In Patient

  MAUDE report 15254499 ↗