CROSSER® CRUS6106Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10801741125642), received between Mar 31, 2017 and May 20, 2022 — classified as 2 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (9 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.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 20, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A RECANALIZATION PROCEDURE, THE TIP OF THE CATHETER ALLEGEDLY BROKE OFF IN PLAQUE. REPORTEDLY THE TIP REMAINS IN PATIENT BUT TRAPPED BY STENT IN ILIAC. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14460571 ↗
• InjuryApr 11, 2022Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT DURING A RECANALIZATION PROCEDURE, THE END OF THE CATHETER ALLEGEDLY BROKE. IT WAS FURTHER REPORTED THAT TIP OF THE CATHETER WAS ALLEGEDLY HANGING ON BY A THREAD. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Vascular Dissection

  MAUDE report 14071043 ↗
• MalfunctionMar 31, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A RECANALIZATION PROCEDURE, THE CATHETER ALLEGEDLY GOT STUCK IN THE LEFT ILIAC LESION AND RIPPED OFF. IT WAS FURTHER REPORTED THAT TIP OF CATHETER ALLEGEDLY DETACHED AND REMAINED IN THE PATIENT BODY. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13965744 ↗
• InjuryMay 18, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A RECANALIZATION PROCEDURE, THE TIP OF THE CATHETER ALLEGEDLY DETACHED. IT WAS FURTHER REPORTED THAT THE TIP WAS LEFT IN THE CALCIFIED LESION. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11839990 ↗
• MalfunctionFeb 9, 2021Detachment of Device or Device Component; Material Deformation; Material Split, Cut or Torn; Detachment of Device or Device Component; Material Deformation; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING PREPARATION FOR A RECANALIZATION CATHETER PROCEDURE, THE CATHETER TIP ALLEGEDLY APPEARED TO BE DEFORMED. IT WAS FURTHER REPORTED THAT ANOTHER RECANALIZATION CATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 11302751 ↗
• MalfunctionOct 21, 2020Break; Noise, Audible; Break; Noise, Audible

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE CATHETER WAS ALLEGEDLY BROKE AND THE DEVICE WAS MAKING A WEIRD NOISE. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10710054 ↗
• MalfunctionJul 19, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL CRUS6106 RECANALIZATION CATHETER ALLEGEDLY THE TIP DETACHED AFTER FIVE MINUTES OF ACTIVATION. THE TIP REMAINS IN THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. PATIENT WAS MALE, AGE AND WEIGHT WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8807569 ↗
• MalfunctionSep 26, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTING THAT DURING TREATMENT OF AN OCCLUSION IN THE MID SFA, AFTER APPROXIMATELY THREE MINUTES AND THIRTY SECONDS OF ACTIVATION, THE DISTAL TIP OF THE RECANALIZATION CATHETER ALLEGEDLY DETACHED AND REMAINED EMBEDDED IN THE LESION. IT WAS FURTHER REPORTED THAT THE HEALTH CARE PROVIDER DETERMINED NOT TO RETRIEVE THE TIP SINCE THE DETACHED TIP WOULD NOT CAUSE ANY HEALTH HAZARD TO THE PATIENT. THEREFORE, THE CATHETER WAS REMOVED WITHOUT INCIDENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7912679 ↗
• MalfunctionAug 29, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT TREATMENT IN THE RIGHT SFA VIA ANTEGRADE APPROACH, AFTER APPROXIMATELY ONE MINUTES AND FOURTEEN SECONDS, THE DISTAL TIP OF THE RECANALIZATION CATHETER ALLEGEDLY DETACHED AND REMAINED EMBEDDED IN THE LESION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7827409 ↗
• MalfunctionApr 18, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING TREATMENT OF A HEAVY CALCIFIED OCCLUSION IN THE COMMON ILIAC, AFTER APPROXIMATELY TWO AND A HALF TO THREE MINUTES OF ACTIVATION, THE DISTAL TIP OF THE RECANALIZATION CATHETER ALLEGEDLY DETACHED. IT WAS FURTHER REPORTED THAT THE HEALTH CARE PROVIDER WAS ABLE TO RETRACT THE CATHETER AND THE DETACHED DISTAL TIP INTO THE SUPPORT CATHETER; ALLOWING THE DEVICE TO BE REMOVED AS ONE UNIT WITHOUT INCIDENT. ANOTHER RECANALIZATION CATHETER WAS REPORTEDLY USED AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6502551 ↗
• MalfunctionApr 11, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING TREATMENT IN A HEAVY CALCIFIED OCCLUSION PROCEDURE BEGINNING IN THE SFA AND EXTENDING TO THE POPLITEAL TIBIAL ARTERY, AFTER APPROXIMATELY THREE MINUTES OF ACTIVATION, THE RECANALIZATION CATHETER ALLEGEDLY BROKE APPROXIMATELY 4CM FROM THE DISTAL TIP AND DETACHED. IT WAS FURTHER REPORTED THAT DURING RETRACTION THE BROKEN SEGMENT SECURED BETWEEN THE RECANALIZATION CATHETER AND THE SUPPORT CATHETER AND WAS REMOVED WITHOUT INCIDENT. ANOTHER RECANALIZATION CATHETER WAS REPORTEDLY USED AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6483732 ↗
• MalfunctionMar 31, 2017Retraction Problem; Material Separation; Retraction Problem; Material Separation

  IT WAS REPORTED THAT AFTER THREE MINUTES OF ACTIVATION IN THE ANTERIOR TIBIAL ARTERY, THE RECANALIZATION CATHETER WAS ALLEGEDLY DIFFICULT TO RETRACT THROUGH THE SUPPORT CATHETER. DURING RETRACTION, THE DISTAL TIP OF THE RECANALIZATION CATHETER ALLEGEDLY SEPARATED FROM THE OUTER CATHETER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6450331 ↗