Turnpike® Spiral catheter 5641Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI M20656410), received between Sep 28, 2017 and Mar 23, 2018 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Detachment Of Device Component” (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 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.

• MalfunctionMar 23, 2018Detachment Of Device Component; Detachment Of Device Component

  TURNPIKE SPIRAL WAS DAMAGED. THE INFORMATION REPORTED WAS THE "WIRE CAME OFF THE TIP OF THE CATHETER IN THE VESSEL" . IT IS REPORTED THAT THE TIP WAS NOT RETRIEVED AND NOT ON THE WIRE. IT WAS REPORTED AS NO IMPACT OR INJURY TO PATIENT. THE PATIENT WAS STABLE LEAVING THE LAB.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7366991 ↗
• MalfunctionSep 28, 2017Detachment Of Device Component; Detachment Of Device Component

  THE END OF THE CATHETER STARTED TO UNRAVEL. THE SPIRAL STARTED TO UNRAVEL BUT REMAINED INTACT TO THE CATHETER AND WAS REMOVED. NO INTERVENTION WAS REQUIRED. TORTUOSITY AND CALCIUM WERE PRESENT. THERE WAS NO ADVERSE OUTCOME. THE CATHETER WAS REMOVED WITHOUT ISSUE. ADDITIONAL INFORMATION RECEIVED STATES, THE CATHETER WAS REMOVED AND THE DISTAL NYLON COIL WAS STILL ATTACHED TO THE CATHETER SHAFT, NO INTERVENTION WAS NEEDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6902267 ↗