Quick-Cross Support Catheter 518-065 (UDI 00813132020712)Recalls & reported problems
Spectranetics Corporation · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00813132020712), received between Sep 28, 2018 and Sep 28, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Damaged by Another Device” (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
- Device Damaged by Another Device1
- Material Perforation1
- Material Puncture/Hole1
- Mechanical Problem1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 28, 2018Mechanical Problem; Material Puncture/Hole; Material Perforation; Device Damaged by Another Device; Mechanical Problem; Material Puncture/Hole; Material Perforation; Device Damaged by Another Device
DURING A PERIPHERAL VASCULAR SURGERY UTILIZING FEMORAL ACCESS, THE SURGEON STATED WHEN USING THE QUICK-CROSS SUPPORT CATHETER 518-065, THEY COULD NOT GO AS LOW IN THE LEG AS WISHED, PAST THE PROXIMAL ANTERIOR TIBIAL ARTERY. ALSO, WHEN TAKING OUT THE QUICK-CROSS THEY NOTICED A HOLE IN THE CATHETER ABOVE THE TIP. NO DEVICE REMNANTS WERE DETECTED TO BE LEFT IN THE PATIENT. THE CASE WAS SUCCESSFULLY COMPLETED WITH A BALLOON AND GUIDE-WIRE. NO IMPACT ON PATIENT OUTCOME DUE TO THIS EVENT. THIS IS BEING REPORTED DUE TO THE POTENTIAL FOR SERIOUS INJURY WITH RECURRENCE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7920057 ↗
Other Catheter, Percutaneous devices
- WATCHMAN FXD Curve™ Access System M635TU80020Boston Scientific Corporation · Catheter, percutaneous1 recall47 deaths654 reports
- NA C315HIS02Medtronic, Inc. · Catheter, percutaneous1 recall369 reports
- WATCHMAN TruSteer™ Access System M635TU90050Boston Scientific Corporation · Catheter, percutaneous1 recall28 deaths302 reports
- Guidezilla™ II H7493933515060Boston Scientific Corporation · CATHETER, PERCUTANEOUS1 recall3 deaths278 reports
- Velocity Delivery Microcatheter VEL160STR-APenumbra, Inc. · CATHETER, PERCUTANEOUS297 reports
- Guidezilla™ H7493924215050Boston Scientific Corporation · CATHETER, PERCUTANEOUS294 reports
- WATCHMAN™ TruSeal™ Access System M635TU70020Boston Scientific Corporation · Catheter, percutaneous1 recall11 deaths217 reports
- Lantern Delivery Catheter PXSLIMLAN135T45Penumbra, Inc. · CATHETER, PERCUTANEOUS220 reports
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.
How reports and recalls are matched · Editorial policy · Report an error on this page