TURNPIKE IPN913579Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10841156100711), received between May 24, 2024 and Sep 29, 2025 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Material Separation” (2 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 16, 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.

• InjurySep 29, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT: "DURING A PCI TO TREAT IN-STENT RESTENOSIS. THIS IS IN-STENT RESTENOSIS. THEREFORE, PREDILATION WITH A NON-COMPLIANT BALLOON FOLLOWED BY DRUG-COATED BALLOON. DUE TO DISTAL PERFORATION, IT WAS NECESSARY TO EMBOLIZE THE LEAK WITH COILS. THE FIRST MICROCATHETER WAS UNABLE TO PASS THROUGH THE FIRST OLD STENT. THIS IS WHY WE USED THE TURNPIKE INSTEAD. AT THE SAME LOCATION, THE TURNPIKE BECAME STUCK AND WOULD NOT ADVANCE ANY FURTHER. AFTER TWO CLOCKWISE TURNS, IT STILL WOULD NOT ADVANCE. WE DECIDED TO REMOVE THE MICROCATHETER AND PREDILATE THIS SECTION WHERE THE MICROCATHETERS WAS STUCK. WHEN WE REMOVED THE TURNPIKE, THE DISTAL TIP DETACHED AND REMAINED STUCK IN THE OLD STENT. SUBSEQUENTLY, JAILING OF THE BROKEN TIP WITH A NEW STENT. TOOK A NEW MICROCATHETER AND EMBOLIZATION OF 4X COILS TO OCCLUDE THE PERFORATION. IT TOOK SOME TIME TO JAIL THE LOST TIP, BUT ONCE IT WAS DONE, THE PATIENT WAS ABLE TO LEAVE THE CLINIC 48 HOURS LATER WITH NO SEQUELAE RELATED TO THE LOST TIP."

  Patient problems: Foreign Body In Patient

  MAUDE report 23165674 ↗
• MalfunctionMay 24, 2024Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT: "THE TIP OF THE TURNPIKE BROKE OFF. THE CASE WAS COMPLETED WITH A DIFFERENT DEVICE. THE PATIENT WAS REPORTED AS FINE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19390653 ↗