CROSSER® CRUOS106Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 10801741125611), received between Sep 20, 2017 and Apr 4, 2023 — classified as 1 injury, 17 malfunctions.

The most frequently reported specific device problem is “Material Separation” (12 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 4, 2023Break; Crack; Leak/Splash; Break; Crack; Leak/Splash

  IT WAS REPORTED THAT PRIOR TO A RECANALIZATION PROCEDURE, THE CATHETER WAS ALLEGEDLY BROKEN WHEN IT WAS OPENED. IT WAS FURTHER REPORTED WHEN THE CATHETER WAS FLUSHED, THERE WAS SOME FLUID COMING OUT OF THE SIDE OF THE CATHETER JUST ABOUT AN INCH FROM THE PORT. REPORTEDLY UPON CLOSER OBSERVATION, THERE WAS A SMALL CRACK IN THE SIDE OF THE CATHETER THAT WAS LEAKING FLUID. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16672349 ↗
• MalfunctionFeb 22, 2022Difficult to Remove; Retraction Problem; Material Separation; Device-Device Incompatibility; Difficult to Remove; Retraction Problem; Material Separation; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A RECANALIZATION PROCEDURE IN THE RIGHT ILIAC WITH TOTAL OCCLUSION, THE DEVICE ALLEGEDLY HAD COMPATIBILITY ISSUE. IT WAS FURTHER REPORTED THAT THE DEVICE HAD WITHDRAWAL ISSUE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13576904 ↗
• MalfunctionJan 15, 2020Overheating of Device; Material Separation; Material Twisted/Bent; Overheating of Device; Material Separation; Material Twisted/Bent

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL CRUOS106, RECANALIZATION CATHETER, ALLEGEDLY EXPERIENCED AN OVERHEATING ISSUE. THIS INFORMATION WAS RECEIVED FROM A SINGLE SOURCE. THIS MALFUNCTION INVOLVED A (B)(6) YEAR OLD FEMALE PATIENT WITH NO CONSEQUENCES. THE PATIENT'S WEIGHT WAS NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9591783 ↗
• MalfunctionJan 14, 2020Fracture; Overheating of Device; Fracture; Overheating of Device

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL CRUOS106 RECANALIZATION CATHETER ALLEGEDLY EXPERIENCED OVER HEATING AND A FRACTURE. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THIS MALFUNCTION INVOLVED A PATIENT WITH NO REPORTED PATIENT INJURY. THE PATIENT WAS A 68 YEAR OLD MALE THAT WEIGHED 75 KGS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9588903 ↗
• InjuryDec 6, 2019Material Separation; Device-Device Incompatibility; Material Deformation; Patient Device Interaction Problem; Activation Problem; Material Separation; Device-Device Incompatibility; Material Deformation; Patient Device Interaction Problem; Activation Problem

  IT WAS REPORTED THAT DURING TREATMENT OF A 150 CM CHRONIC TOTAL OCCLUSION IN THE POSTERIAL TIBIAL ARTERY VIA COMMON FEMORAL ACCESS, ANTEGRADE APPROACH, THE RECANALIZATION CATHETER ALLEGEDLY BECAME STUCK WITH THE GUIDEWIRE AFTER 57 SECONDS OF ACTIVATION. IT WAS FURTHER REPORTED THAT WHEN THE CATHETER WAS ACTIVATED TO BE REMOVED, IT PERFORATED THE VESSEL. THE CATHETER AND GUIDEWIRE WERE REMOVED AS ONE UNIT AND FOUND DAMAGED. REPORTEDLY, THE PROCEDURE WAS COMPLETED WITH DIAMONDBACK ATHERECTOMY AND PTA BALLOON ANGIOPLASTY TO RESOLVE THE BLEEDING CAUSED BY VESSEL PERFORATION. THE PATIENT IS STABLE POST-PROCEDURE.

  Patient problems: Blood Loss; Injury; Perforation of Vessels

  MAUDE report 9429147 ↗
• MalfunctionOct 21, 2019Material Separation; Material Twisted/Bent; Material Separation; Material Twisted/Bent

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL CRUOS106. RECANALIZATION CATHETER ALLEGEDLY EXPERIENCED MATERIAL SEPARATION, AND MATERIAL TWISTED. THIS REPORT WAS RECEIVED FROM A SINGLE SOURCE. THIS EVENT DID INVOLVE PATIENT WITH NO REPORTED PATIENT INJURY. THE PATIENTS AGE, WEIGHT AND GENDER WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9214212 ↗
• MalfunctionOct 15, 2019Material Separation; Material Deformation; Material Twisted/Bent; Material Separation; Material Deformation; Material Twisted/Bent

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL CRUOS106 RECANALIZATION CATHETER ALLEGEDLY EXPERIENCED MATERIAL DEFORMATION, MATERIAL SEPARATION, AND TWISTING. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THIS SINGLE MALFUNCTION HAD ONE PATIENT INVOLVED WITH NO CONSEQUENCES TO THE PATIENT. THE AGE, WEIGHT, AND GENDER OF THE PATIENT WAS NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9195156 ↗
• MalfunctionOct 15, 2019Material Separation; Failure to Advance; Material Separation; Failure to Advance

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL CRUOS106. RECANALIZATION CATHETER ALLEGEDLY EXPERIENCED MATERIAL SEPARATION AND FAILURE TO ADVANCE. THIS REPORT WAS RECEIVED FROM A SINGLE SOURCE. THIS EVENT DID INVOLVE PATIENT WITH NO REPORTED PATIENT INJURY. THE PATIENT'S AGE, WEIGHT AND GENDER WERE NOT PROVIDED

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9195000 ↗
• MalfunctionMay 31, 2019Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED DURING CTO PROCEDURE IN THE RIGHT COMMON FEMORAL ARTERY VIA POSTERIOR TIBIAL ARTERY IN RETROGRADE FASHION ACCESS, IPSILATERAL APPROACH, THE GUIDEWIRE ALLEGEDLY GOT STUCK IN THE RECANALIZATION CATHETER. IT WAS FURTHER REPORTED THAT THE CATHETER AND GUIDEWIRE WERE REMOVED AS ONE SINGLE UNIT. ALLEGEDLY, THE PATIENT WAS SCHEDULED TO RETURN TO COMPLETE TREATMENT OF RIGHT CFA.

  Patient problems: Injury; No Consequences Or Impact To Patient

  MAUDE report 8660154 ↗
• MalfunctionApr 19, 2019Material Separation; Material Twisted/Bent; Material Separation; Material Twisted/Bent

  THIS REPORT SUMMARIZES ONE MALFUNCTION EVENT. A REVIEW OF THE EVENT INDICATED THAT MODEL CRUOS106 CROSSER CTO RECANALIZATION CATHETER EXPERIENCED MATERIAL SEPARATION AND TWISTING OF MATERIAL. OF THIS EVENT, THE DEVICE WAS USED ON THE PATIENT WITH NO REPORTED INJURY. THE MALE PATIENT WEIGHED (B)(6) KGS. AND DID NOT HAVE HIS AGE PROVIDED. THE CRUOS106 CROSSER CTO RECANALIZATION CATHETER WAS RETURNED TO THE MANUFACTURER ALONG WITH TWO PICTURES. THE INVESTIGATION CONFIRMED BOTH PRODUCT PROBLEMS. NEITHER THE DHR REVIEW NOR THE INVESTIGATION WERE ABLE TO DETERMINE A ROOT CAUSE. THE DEVICE WAS LABELED FOR SINGLE USE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8533485 ↗
• MalfunctionApr 8, 2019Material Separation; Material Separation

  THIS REPORT SUMMARIZES ONE(1) MALFUNCTION EVENT. A REVIEW OF THE EVENTS INDICATED THAT MODEL CRUO14SA RECANALIZATION CATHETER ALLEGEDLY EXPERIENCED THE TIP OF THE CATHETER SEPARATING FROM THE DISTAL TIP, WITH THE CORE WIRE HOLDING THE TIP INTACT. THE PROCEDURE WAS COMPLETED WITH DEVICE. THIS REPORT WAS RECEIVED FROM ONE SOURCE. THIS EVENT INVOLVED ONE MALE PATIENT, (B)(6) YEARS OF AGE AND APPROXIMATELY (B)(6) KGS. THIS PATIENT HAD NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8491718 ↗
• MalfunctionApr 8, 2019Break; Material Separation; Noise, Audible; Break; Material Separation; Noise, Audible

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT. A REVIEW OF THE EVENTS INDICATED THAT MODEL CRUOS106 RECANALIZATION CATHETER EXPERIENCED AN ABNORMAL NOISE, MATERIAL SEPARATION, AND A BREAK. THIS REPORT WAS RECEIVED FROM A SINGLE SOURCE. THE EVENT INVOLVED A PATIENT WITH NO REPORTED INJURY. THE PATIENT AGE, WEIGHT, AND SEX WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8491717 ↗
• MalfunctionJul 12, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE RECANALIZATION CATHETER ALLEGEDLY BECAME LODGED IN THE DISTAL CAP OF A PROXIMAL POPLITEAL CTO. IT WAS FURTHER REPORTED THAT AS THE HEALTH CARE PROVIDER PULLED BACK ON THE RECANALIZATION CATHETER, THE DISTAL TIP ALLEGEDLY DETACHED AND REMAINED IN THE CTO. REPORTEDLY, THE HCP ATTEMPTED TO CROSS THE LESION WITH AN 0.035" GUIDEWIRE BUT WAS UNSUCCESSFUL. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7684094 ↗
• MalfunctionJun 14, 2018Material Separation; Device-Device Incompatibility; Material Separation; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING TREATMENT OF A TIBIAL CHRONIC TOTAL OCCLUSION, THE GUIDEWIRE SEEMED TIGHT AND THE RECANALIZATION CATHETER ALLEGEDLY WAS DIFFICULT TO ADVANCE. IT WAS FURTHER REPORTED THAT UPON REMOVAL OF THE RECANALIZATION CATHETER, THE CATHETER WAS ALLEGEDLY STICKING ON TO THE WIRE AND SALINE WAS LEAKING FROM THE SIDE WALL OF THE CATHETER APPROXIMATELY 15 CM FROM THE DISTAL TIP. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7602038 ↗
• MalfunctionJun 11, 2018Material Separation; Material Separation

  IT WAS REPORTED THAT DURING THE USE OF A RECANALIZATION CATHETER IN THE POSTERIOR TIBIAL, THE DISTAL TIP OF THE RECANALIZATION CATHETER ALLEGEDLY SEPARATED FROM THE CATHETER BUT REMAINED ATTACHED TO THE CORE WIRE. REPORTEDLY, ANOTHER RECANALIZATION CATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7589591 ↗
• MalfunctionJan 5, 2018Retraction Problem; Retraction Problem

  IT WAS REPORTED THAT DURING TREATMENT OF A LESION SITE IN THE POPLITEAL, THE RECANALIZATION CATHETER ALLEGEDLY BECAME STUCK IN THE SUPPORT CATHETER'S SHEATH. IT WAS FURTHER REPORTED THAT THE RECANALIZATION CATHETER AND THE SUPPORT CATHETER WERE ALLEGEDLY REMOVED. REPORTEDLY, ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7170423 ↗
• MalfunctionJan 5, 2018Retraction Problem; Retraction Problem

  IT WAS REPORTED THAT DURING TREATMENT OF A LESION SITE IN THE POPLITEAL, THE RECANALIZATION CATHETER ALLEGEDLY BECAME STUCK IN THE SUPPORT CATHETER'S SHEATH. IT WAS FURTHER REPORTED THAT THE RECANALIZATION CATHETER AND THE SUPPORT CATHETER WERE ALLEGEDLY REMOVED. REPORTEDLY, ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7170139 ↗
• MalfunctionSep 20, 2017Material Separation; Device-Device Incompatibility; Material Separation; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING PREPARATION, THE GUIDEWIRE ALLEGEDLY WOULD NOT PASS THROUGH THE DISTAL TIP OF THE RECANALIZATION CATHETER. ANOTHER RECANALIZATION CATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 6880274 ↗