Turnpike® Gold catheter 5621Recalls & reported problems
Vascular Solutions, Inc. · Class 2
Data updated Oct 18, 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 M20656210), received between Aug 24, 2017 and Aug 24, 2017 — classified as 1 injury.
The most frequently reported specific device problem is “Detachment Of Device Component” (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.
Most reported problems
Device problems
- Detachment Of Device Component1
Patient problems
- Device Embedded In Tissue or Plaque1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 24, 2017Detachment Of Device Component; Detachment Of Device Component
AN (B)(6) MALE WITH DIABETES WITH VERY CALCIFIED SEGMENT IN THE LOWER EXTREMITIES BELOW THE AT IN THE TOP OF FOOT. AFTER TRYING A TURNPIKE SPIRAL WHICH DID NOT ADVANCE, THE DOCTOR USED A TURNPIKE GOLD ADVANCED THROUGH THE VERY DIFFICULT CALCIUM BY TORQUING CLOCKWISE AND PUSHING THE CATHETER AS IT MOVED DOWN THE VESSEL. ONCE THROUGH HE WAS TRYING TO REMOVE THE TURNPIKE GOLD WITH COUNTER CLOCKWISE TURNS AND THE CATHETER WAS NOT MOVING, SO HE KEPT TORQUING THE TURNPIKE GOLD. THE CATHETER AND WIRE BROKE APART. FIFTEEN (15) CM OF TURNPIKE GOLD AND WIRE WAS LEFT IN VESSEL AFTER TRYING TO SNARE WITH NO SUCCESS. DOCTOR SAID IT WAS NOT AN ISSUE WITH THE TURNPIKE GOLD. SENT PATIENT TO THE OPERATING ROOM (OR) FOR RETRIEVAL.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 6816834 ↗
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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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