TURNPIKE IPN917514Recalls & reported problems
Teleflex Incorporated · Turnpike LP, 150cm, TCT · Class 2
All models of TURNPIKE (18)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10841156108748), received between Mar 9, 2023 and Mar 15, 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 16, 2026.
Most reported problems
Device problems
- Break1
- Unraveled Material1
Patient problems
- Device Embedded In Tissue or Plaque1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 15, 2023Unraveled Material; Unraveled Material
IT WAS REPORTED THAT: A TURNPIKE UNRAVELLED. ADDITIONAL INFORMATION ON 11MAR2023: DURING A CTO OF THE RCA PROCEDURE ON THE (B)(6) 2023, TURNPIKE WAS USED RETROGRADE THROUGH THE LAD AND SEPTAL TO THE RCA. THE TURNPIKE LP UNRAVELLED AT THE SHAFT. PHYSICIAN FELT A LOT OF RESISTANCE WHILE REMOVING THE TURNPIKE. HE WAS USING IT FOR ABOUT 10 MINS OVER A GUIDEWIRE. THE TURNPIKE LP WAS REMOVED IN ITS ENTIRETY AND THERE WAS NO MATERIAL LEFT IN THE VESSEL. A MICROCATHETER WAS USED IN THE PROCEDURE. THE CURRENT PATIENT CONDITION IS FINE, AND NO PATIENT HARM WAS REPORTED FROM THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16543779 ↗InjuryMar 9, 2023Break; Break
IT WAS REPORTED THAT: "MANAGER GOT A MESSAGE REGARDING THE TIP BREAKING OFF A TURNPIKE. TRIED REACHING OUT TO CATH LAB MANAGER DEVICE CURRENTLY GOING THROUGH THE HOSPITAL INVESTIGATION PROCESS." ADDITIONAL INFORMATION ON 07MAR2023: DURING A CARDIAC CATHETERIZATION ON THE (B)(6) 2023, THE TURNPIKE TIP GOT STUCK ON THE SIDE OF A STENT. THE OPERATOR WAS ABLE TO PLACE AN ADDITIONAL STENT TO CRUSH THE FRACTURED TIP TO THE WALL OF THE ARTERY. THE PATIENT DID RECOVER AND IS IN GOOD CONDITION. THE PATIENT'S CURRENT CONDITION IS DOING WELL POST PROCEDURE.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 16511359 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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