CROSSER® CRUS106Recalls & reported problems
Bard Peripheral Vascular, Inc. · CROSSER® CTO Recanalization Catheter 14S, Rapid Exchange, 106cm · Class 2
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10801741125635), received between Mar 7, 2017 and Jan 24, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Device-Device Incompatibility2
- Material Separation2
- Detachment of Device or Device Component1
- Failure to Advance1
Patient problems
- No Consequences Or Impact To Patient2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 24, 2025Material Separation; Device-Device Incompatibility; Material Separation; Device-Device Incompatibility
IT WAS REPORTED THAT DURING A RECANALIZATION PROCEDURE, THE CATHETER WAS ALLEGEDLY STICK TO THE WIRE. IT WAS FURTHER REPORTED THAT THE WIRE ACCESS WAS LOST WHILE TRYING TO RETRIEVE THE DEVICE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21231529 ↗MalfunctionMar 20, 2017Material Separation; Failure to Advance; Device-Device Incompatibility; Material Separation; Failure to Advance; Device-Device Incompatibility
IT WAS REPORTED THAT DURING TREATMENT IN THE ANTERIOR TIBIAL THE RECANALIZATION CATHETER ALLEGEDLY COULD NOT ADVANCE TO THE TARGET LESION; THEREFORE, THE HEALTH CARE PROVIDER REMOVED IT, AND UPON REMOVAL, THE RECANALIZATION CATHETER ALLEGEDLY BECAME STUCK ON THE GUIDEWIRE. THEREFORE, THE CATHETER AND GUIDEWIRE WERE REMOVED AS ONE UNIT. REPORTEDLY, ANOTHER WIRE AND CATHETER WERE USED THROUGH THE SAME ACCESS SITE TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6419679 ↗MalfunctionMar 7, 2017Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING USE IN A HEAVILY CALCIFIED OCCLUSION IN THE LEFT ILIAC, AFTER APPROXIMATELY THIRTY SECONDS OF ACTIVATION, THE DISTAL TIP OF THE RECANALIZATION CATHETER ALLEGEDLY DETACHED. IT WAS FURTHER REPORTED THAT THE DETACHED TIP WAS RETRIEVED USING A SNARE. ANOTHER CATHETER WAS USED TO PERFORM THE PROCEDURE, RESULTING IN VESSEL PATENCY WITH GOOD BLOOD FLOW. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6386195 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.