TURNPIKE IPN931271Recalls & reported problems
Teleflex Incorporated · Turnpike Spiral, 135cm, TCT · Class 2
All models of TURNPIKE (18)
Data updated Oct 18, 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 10841156103927), received between Dec 3, 2025 and Feb 9, 2026 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Difficult to Advance” (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.
Reports received per month
Most reported problems
Device problems
- Difficult to Advance1
- Material Separation1
- Physical Resistance/Sticking1
Patient problems
- Foreign Body In Patient1
- Perforation1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryFeb 9, 2026Material Separation
IT WAS REPORTED THAT: "THE TIP OF THE CATHETER DISCONNECTED AND STAYED INSIDE THE PATIENT. THE TIP REMAINS IN THE PATIENT. THE PATIENT MUST NOW TAKE BLOOD THINNERS OR ANTITHROMBOTIC MEDICATION. THE PATIENT IS REPORTED AS "FINE".
Patient problems: Foreign Body In Patient
MAUDE report 24290020 ↗MalfunctionDec 3, 2025Difficult to Advance; Physical Resistance/Sticking; Difficult to Advance; Physical Resistance/Sticking
IT WAS REPORTED THAT "TP SPIRAL USED WITH A GUIDEWIRE IN A CTO / COMPLEX CASE - SO ARTERIES NEEDED SOME WORK. DR SUSPECTED THERE WAS AN ISSUE WITH THE HUB. THE GUIDEWIRE GOT STUCK AND COULD NOT BE MOVED FORWARD THROUGH THE MICROCATHETER. THE DR TRIED TO MOVE IT, BUT IT LED TO A PERFORATION. PATIENT IS FINE. DR NOT SURE WHETHER THE TP SPIRAL WAS THE ISSUE BUT WANTED TO INVESTIGATE."
Patient problems: Perforation
MAUDE report 23704268 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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