TrapLiner™ catheter 5567Recalls & 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 M20655670), received between Oct 24, 2017 and Mar 29, 2018 — 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 Component2
Patient problems
- No Known Impact Or Consequence To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 29, 2018Detachment Of Device Component; Detachment of Device or Device Component; Detachment Of Device Component; Detachment of Device or Device Component
WE WERE USING AN 8FR LAUNCHER GUIDE AND A TURNPIKE LP WITH A RUN THROUGH WIRE. THE 7F TRAPLINER JUST SNAPPED AS WE WERE ADVANCING THROUGH THE GUIDE. WE WEREN'T EVEN PUSHING HARD. LIKELY JUST DEFECTIVE. DIDN'T RUIN THE CASE. USED AN 8FR TRAPLINER THAT WORKED WELL. IT BROKE INTO 2 PIECES WHEN THEY WERE INSERTING IT INTO THE GUIDE. REPORTED AS: I DONT THINK THE CATHETER WAS ACTUALLY IN THE BODY. PATIENT OUTCOME WAS REPORTED AS FINE, PATIENT NOT AFFECTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7380925 ↗MalfunctionOct 24, 2017Detachment Of Device Component; Detachment of Device or Device Component; Detachment Of Device Component; Detachment of Device or Device Component
THE TRAPLINER PUSH ROD BROKE WHILE LOADING IT ON THE GUIDWIRE. DID NOT OBSERVE ANY ROUGH HANDLING OF THE CATHETER PRIOR TO THIS EVENT. THE TRAPLINER BROKE WHILE LOADING ON THE WIRE OUTSIDE THE PATIENT. NO PATIENT INTERACTION. IT WAS NOT USED IN THIS CASE. THEN USED A GUIDELINER AND A TRAPPING BALLOON.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6972596 ↗
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- 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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