TURNPIKE IPN039144Recalls & reported problems
Teleflex Incorporated · Turnpike Smooth, 135cm · Class 2
All models of TURNPIKE (18)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10841156105068), received between Apr 14, 2021 and Apr 14, 2021 — classified as 1 injury.
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
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Hematoma1
- Perforation1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AS REPORTED: DURING A SUCCESSFUL PCI TO A NON-TORTUOUS, MODERATELY CALCIFIC CTO OF THE PROXIMAL RCA ON CTO PCI STUDY SUBJECT (B)(6), SUBJECT SUFFERED AN ELLIS GRADE 1 VESSEL PERFORATION TO AN EPICARDIAL COLLATERAL FROM THE CFX WHICH RESULTED IN A RESIDUAL HEMATOMA. MANY DEVICES, BOTH STUDY AND NON-STUDY, WERE USED IN THE PROCEDURE. STUDY DEVICES INCLUDED A TURNPIKE MICROCATHETER, TURNPIKE LP MICROCATHETER AND A RAIDER GUIDEWIRE. IT IS UNKNOWN WHICH DEVICE CAUSED THE PERFORATION BUT FELT TO BE CAUSED BY A NON-STUDY DEVICE. PERFORATION TREATED WITH COIL EMBOLIZATION (0.014" COILS X 2) WITH RESOLUTION, HEMATOMA TREATED WITH CUTTING BALLOON WITH MODERATE SUCCESS OF DECOMPRESSION AND SMALL RESIDUAL HEMATOMA. TEE PERFORMED PRIOR TO DISCHARGE SHOWED NO PERICARDIAL EFFUSION. DISCHARGED HOME NEXT DAY WITH NO FURTHER SEQUELAE. ASSOCIATED TO MDRS: 2134812-2021-00032 RAIDER GW. 2134812-2021-00034 TURNPIKE LP.
Patient problems: Hematoma; Perforation
MAUDE report 11667928 ↗
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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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