TrapLiner™ catheter 5568Recalls & reported problems
Vascular Solutions, Inc. · The TrapLiner catheter is intended for use in conjunction with guide catheters to access discrete regions of the coronary and/or peripheral vasculature, to facilitate placement of interventional device while maintaining the position of a guidewire within the vasculature. · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI M20655680), received between Mar 11, 2017 and Dec 6, 2017 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Detachment Of Device Component” (2 reports).
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
- Detachment Of Device Component2
- Detachment of Device or Device Component1
Patient problems
- No Consequences Or Impact To Patient1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 6, 2017Detachment Of Device Component; Detachment Of Device Component
PHYSICIAN PULLED OUT THE TRAPLINER 8F AFTER HAVING SOME RESISTANCE DURING AWE CTO CASE, AND FOUND THAT THE HALF PIPE HAS PULLED AWAY FROM THE HYPOTUBE, HOWEVER NOT DETACHED. PHYSICIAN DISCOVERED THE HALF PIPE PULLED AWAY AFTER REMOVING THE DEVICE OUT OF THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7087293 ↗MalfunctionMar 11, 2017Detachment Of Device Component; Detachment of Device or Device Component; Detachment Of Device Component; Detachment of Device or Device Component
THE PHYSICIAN NOTICED A KINK IN THE DISTAL BACKBONE OF THE TRAPLINER. WHEN A TECH PICKED UP THE TRAPLINER AFTER IT HAD BEEN REMOVED FROM THE PATIENT, THE DEVICE SEPARATED INTO 2 PIECES.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6397706 ↗
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- WATCHMAN TruSteer™ Access System M635TU90050Boston Scientific Corporation · Catheter, percutaneous1 recall28 deaths302 reports
- Guidezilla™ II H7493933515060Boston Scientific Corporation · CATHETER, PERCUTANEOUS1 recall3 deaths278 reports
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- 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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