Turnpike® catheter 5643Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI M20656430), received between Mar 28, 2017 and Jan 16, 2019 — classified as 3 malfunctions.

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 16, 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.

• MalfunctionJan 16, 2019Separation Problem; Separation Problem

  RETROGRADE FROM VEIN GRAFT TO OM TO OPEN NATIVE CX. VERY CALCIFIED AND THE RETROGRADE KNUCKLE WAS WRAPPING AROUND THE VESSEL SUBINTIMAL AROUND THE CALCIUM. MID CX IT WAS IN THE LAO VIEW DOING ALMOST A 180 DEGREE TURN IN A SHORT SEGMENT. GOT THE TURNPIKE UP TO THE GUIDELINES AFTER LOTS OF TORQUE (BOTH WAYS). GOT TURNPIKE INTO THE GUIDELINES (8 FR) BUT PHYSICIAN THOUGHT IT WAS DIFFICULT TO TRACK INTO THE GL. EVENTUALLY GOT IN AND DELIVERED. WHEN PHYSICIAN TRIED TO TAKE THE TURNPIKE OUT, IT WAS STUCK AND WOULD NOT COME BACK. HE BALLOONED DOWN THE SIDE OF THE TURNPIKE ON AN ANTEGRADE KNUCKLE AND THIS DID NOT RELEASE THE TURNPIKE. EVENTUALLY HE PULLED THE TURNPIKE OUT OF THE ANTEGRADE MICRO CATHETER AND THEN THE TURNPIKE CAME BACK THROUGH THE TORTUOSITY. THIS WAS A CASE OF SUPREME TORTUOSITY AND CALCIUM RESTRICTING THE DEVICE. THE ANGLES LOOKED SEVERE. NO PATIENT IMPACT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8252408 ↗
• MalfunctionApr 18, 2018Detachment Of Device Component; Detachment Of Device Component

  CALCIFIED LESION WHERE ONLY WIRE WOULD PASS. DR. INSERTED 150CM REGULAR TURNPIKE AND TORQUED CATHETER CLOCKWISE AND COUNTER CLOCKWISE WHILE PUSHING CATHETER FORWARD. THE TURNPIKE DID NOT CROSS THE LESION. DR. DECIDED TO TAKE OUT REGULAR TURNPIKE AND TRY TURNPIKE GOLD. UPON WITHDRAWING TURNPIKE IT WOULDN'T MOVE ON THE WIRE. IT WAS DETERMINED IT WAS STUCK AND TURNPIKE ALONG WITH THE WIRE WERE BOTH REMOVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7441195 ↗
• MalfunctionMar 28, 2017Break; Break

  DISTAL TIP BROKE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6440007 ↗