CROSSER® CRUS6ARecalls & reported problems

Summary

The FDA's MAUDE database contains 47 adverse event reports that list this exact device (DI 10801741125659), received between Oct 5, 2016 and Dec 13, 2023 — classified as 5 injuries, 42 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (29 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

Recent adverse event reports

The 25 most recent of 47 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 13, 2023Break; Difficult to Remove; Device-Device Incompatibility; Activation Problem; Break; Difficult to Remove; Device-Device Incompatibility; Activation Problem

  IT WAS REPORTED THAT DURING A RECANALIZATION PROCEDURE, THE CATHETER ALLEGEDLY BROKE. IT WAS FURTHER REPORTED THAT THE TIP OF THE DEVICE ALLEGEDLY STOPPED WORKING AND THE CATHETER ALLEGEDLY GOT STUCK IN THE SUPPORT CATHETER. REPORTEDLY BOTH THE CATHETERS WERE REMOVED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18316956 ↗
• MalfunctionJul 11, 2023Retraction Problem; Stretched; Detachment of Device or Device Component; Retraction Problem; Stretched; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE RECANALIZATION PROCEDURE, THE CATHETER TIP ALLEGEDLY BROKE WHEN THE DEVICE WAS BEING PULLED BACK OUT OF THE PATIENT. IT WAS FURTHER REPORTED THAT THE TIP OF THE CATHETER WAS UNABLE TO BE RETRIEVED AS THE VESSEL WAS COMPLETELY OCCLUDED WHERE THE TIP WAS BROKEN OFF. REPORTEDLY, THE CATHETER TIP WAS LEFT IN THE PATIENT. FURTHERMORE, NO ADDITIONAL TREATMENT WAS DONE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17300213 ↗
• MalfunctionMay 30, 2023Break; Retraction Problem; Failure to Advance; Device-Device Incompatibility; Material Twisted/Bent; Break; Retraction Problem; Failure to Advance; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A RECANALIZATION PROCEDURE IN THE LEFT SUPERFICIAL ARTERY VIA RIGHT GROIN ACCESS, THE CATHETER ALLEGEDLY BECAME STUCK IN THE LESION. IT WAS FURTHER REPORTED THAT THE CATHETER WAS ALLEGEDLY COMPLETELY BROKEN AND STUCK INSIDE THE SUPPORT CATHETER. FURTHERMORE, THE CATHETER ALLEGEDLY HAD DIFFICULTY IN REMOVING FROM THE PATIENT. REPORTEDLY, THE PHYSICIAN WAS ABLE TO REMOVE THE DEVICE FROM THE PATIENT WITHOUT RIPPING THE VESSEL APART. THE CROSSER IS STILL STUCK INSIDE THE SUPPORT CATHETER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17018301 ↗
• MalfunctionJun 9, 2022Break; Activation Problem; Break; Activation Problem

  IT WAS REPORTED THAT DURING A RECANALIZATION PROCEDURE VIA MID SUPERFICIAL FEMORAL ARTERY, THE DEVICE ALLEGEDLY FAILED THE OUT OF THE BODY TEST. IT WAS FURTHER REPORTED THAT CATHETER WAS ALLEGEDLY BROKEN APPROXIMATELY TWO CM FROM THE TIP OF THE CATHETER. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14641019 ↗
• MalfunctionJun 18, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT DURING THE RECANALIZATION PROCEDURE, THE DEVICE ALLEGEDLY HAD A FOREIGN MATERIAL. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12024132 ↗
• MalfunctionApr 15, 2021Break; Fracture; Detachment of Device or Device Component; Insufficient Device Problem Information; Break; Fracture; Detachment of Device or Device Component; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING A RECANALIZATION PROCEDURE, THE CORE WIRE ALLEGEDLY DETACHED ALONG WITH THE MARKER BAND. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11669735 ↗
• InjuryApr 5, 2021Detachment of Device or Device Component; Device Contamination with Chemical or Other Material; Detachment of Device or Device Component; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT DURING A RECANALIZATION PROCEDURE, THE TIP ALLEGEDLY HAD FOREIGN MATERIAL. IT WAS FURTHER REPORTED THAT THE CATHETER TIP ALLEGEDLY BROKE-OFF INSIDE THE PATIENT. PATIENT STATUS WAS UNKNOWN.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11612650 ↗
• MalfunctionMar 24, 2021Break; Fracture; Material Puncture/Hole; Material Split, Cut or Torn; Break; Fracture; Material Puncture/Hole; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A RECANALIZATION PROCEDURE, THE TIP OF THE CATHETER SPLIT AND THE TIP OF THE DEVICE BROKEN. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11559241 ↗
• InjuryJan 6, 2021Detachment of Device or Device Component; Migration; Detachment of Device or Device Component; Migration

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE DEVICE WAS ALLEGEDLY FRACTURED OFF AND THE TIP MIGRATED INTO THE RIGHT ILLIAC ARTERY. THE PATIENT STATUS WAS UNKNOWN.

  Patient problems: Foreign Body In Patient

  MAUDE report 11122959 ↗
• InjuryDec 17, 2020Overheating of Device; Detachment of Device or Device Component; Overheating of Device; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE TIP ALLEGEDLY DETACHED. IT WAS FURTHER REPORTED THAT, THE CATHETER BECAME VERY HOT AND THE REMAINING DETACHED PARTS WERE LEFT IN PATIENT. THE PROCEDURE WAS ABORTED. THERE PATIENT STATUS WAS UNKNOWN.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11026736 ↗
• InjurySep 14, 2020Break; Detachment of Device or Device Component; Material Twisted/Bent; Break; Detachment of Device or Device Component; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A RECANALIZATION PROCEDURE THE CATHETER TIP ALLEGEDLY BROKEN. IT WAS FURTHER REPORTED THAT SMALL SEGMENT REMAINED IN PATIENT. REPORTEDLY MEDICAL INTERVENTION WAS REQUIRED TO REMOVE THE BROKEN SEGMENT. THE CURRENT PATIENT STATUS IS UNKNOWN.

  Patient problems: Injury

  MAUDE report 10526766 ↗
• MalfunctionJul 16, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATES THAT MODEL CRUS6A RECANALIZATION CATHETER ALLEGEDLY EXPERIENCED DETACHMENT OF DEVICE COMPONENT. THE INFORMATION WAS RECEIVED FROM ONE SOURCE. THE EVENT INVOLVED A PATIENT WITH NO KNOWN IMPACT TO THE PATIENT. AGE, WEIGHT AND GENDER WAS NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10285556 ↗
• MalfunctionApr 15, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATES THAT MODEL CRUS6A, RECANALIZATION CATHETER, ALLEGEDLY EXPERIENCED DETACHMENT OF DEVICE OR DEVICE COMPONENT. THIS INFORMATION WAS RECEIVED FROM A SINGLE SOURCE. THIS MALFUNCTION INVOLVED A PATIENT WITH NO CONSEQUENCES. THE PATIENT'S AGE, WEIGHT, AND GENDER WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9963757 ↗
• MalfunctionJan 15, 2020Detachment of Device or Device Component; Difficult to Advance; Detachment of Device or Device Component; Difficult to Advance

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL CRUS6A. RECANALIZATION CATHETER ALLEGEDLY EXPERIENCED DETACHMENT OF DEVICE OR DEVICE COMPONENT AND DIFFICULT TO ADVANCE. THIS REPORT WAS RECEIVED FROM A SINGLE SOURCE. THIS EVENT DID INVOLVE PATIENT WITH NO REPORTED PATIENT INJURY. THE PATIENT IS (B)(6) YEARS OF AGE, THE GENDER IS MALE, AND THE WEIGHT IS (B)(6) LBS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9591786 ↗
• MalfunctionJan 15, 2020Failure to Advance; Detachment of Device or Device Component; Failure to Advance; Detachment of Device or Device Component

  THIS REPORT SUMMARIZES ONE MALFUNCTION. THE INFORMATION REVIEWED INDICATED THAT MODEL CRUS6A RECANALIZATION CATHETER ALLEGEDLY EXPERIENCED DETACHMENT OF DEVICE OR DEVICE COMPONENT AND FAILURE TO ADVANCE. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE MALFUNCTION INVOLVED A PATIENT WITH NO REPORTED CONSEQUENCES. THE (B)(6)YEAR OLD MALE PATIENT WEIGHED (B)(6) LBS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9591386 ↗
• MalfunctionJan 15, 2020Fracture; Material Twisted/Bent; Material Split, Cut or Torn; Fracture; Material Twisted/Bent; Material Split, Cut or Torn

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATES THAT MODEL CRUS6A RECANALIZATION CATHETER EXPERIENCED A FRACTURE, TWISTED MATERIAL, AND MATERIAL SPLIT. THE INFORMATION WAS RECEIVED FROM ONE SOURCE. THE MALFUNCTION INVOLVED A PATIENT WITH NO REPORTED PATIENT INJURY. THE MALE PATIENT IS (B)(6) YEARS OLD AND WEIGHS (B)(6) POUNDS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9591279 ↗
• MalfunctionJan 13, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  THIS REPORT SUMMARIZES TWO MALFUNCTIONS. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL CRUS6A RECANALIZATION CATHETER ALLEGEDLY EXPERIENCED A DETACHMENT. THIS INFORMATION WAS RECEIVED FROM VARIOUS SOURCES. BOTH MALFUNCTIONS INVOLVED PATIENTS WITH NO REPORTED CONSEQUENCES. ONE PATIENT WAS REPORTED AS A (B)(6)-YEAR-OLD MALE; ALL OTHER PATIENT DETAILS WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9582066 ↗
• MalfunctionJul 11, 2019Break; Leak/Splash; Break; Leak/Splash

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL CRUS6A RECANALIZATION CATHETER ALLEGEDLY BROKE AND LEAKED DURING PREPARATION. ANOTHER WIRE AND CATHETER WERE USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INVOLVEMENT. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. PATIENT AGE, WEIGHT, AND GENDER WERE NOT PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 8783175 ↗
• MalfunctionJul 11, 2019Break; Reflux within Device; Break; Reflux within Device

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL CRUS6A. RECANALIZATION CATHETER ALLEGEDLY BROKE. IT WAS FURTHER REPORTED THAT ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THIS INFORMATION WAS RECEIVED FROM SINGLE SOURCE. THIS EVENT DID INVOLVE PATIENT WITH NO REPORTED PATIENT INJURY. THE PATIENT IS (B)(6) YEARS OF AGE, THE GENDER IS NOT PROVIDED, AND THE WEIGHT IS (B)(6) LBS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8782986 ↗
• MalfunctionApr 9, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  THIS REPORT SUMMARIZES THREE MALFUNCTION EVENTS. A REVIEW OF THE EVENTS INDICATED THAT MODEL CRUS6A RECANALIZATION CATHETER ALLEGEDLY THE DISTAL TIP OF THE CATHETER WAS DETACHED. THESE REPORTS WERE RECEIVED FROM VARIOUS SOURCES. OF THE ONE EVENTS, DID NOT INVOLVE PATIENTS, AND TWO INVOLVED PATIENTS WITH NO REPORTED PATIENT INJURY. TWO PATIENTS' AGE RANGED FROM 66-76 YEARS AND ONE PATIENT'S WEIGHT WAS 192 LBS. ALL OTHER PATIENT AGE AND WEIGHT WERE NOT PROVIDED. ONE WAS MALE AND ONE WAS FEMALE. ALL OTHER PATIENT GENDER WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient; No Patient Involvement

  MAUDE report 8497574 ↗
• InjuryDec 19, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT AFTER APPROXIMATELY FIVE MINUTES ACTIVATION TIME IN A CALCIFIED LEFT SFA VIA GROIN, THE TIP OF THE RECANALIZATION CATHETER WAS ALLEGEDLY DETACHED FROM THE CATHETER AND "REMAIN" IN THE PATIENT. IT WAS FURTHER REPORTED THAT STENT WAS PLACED TO SECURE THE TIP TO THE ARTERY WALL. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: Injury; No Consequences Or Impact To Patient

  MAUDE report 8181217 ↗
• MalfunctionDec 3, 2018Break; Leak/Splash; Break; Leak/Splash

  IT WAS REPORTED THAT DURING THE OPERATION TEST OF THE DEVICE BEFORE USE ON THE PATIENT, SALINE ALLEGEDLY LEAKED OUT OF THE HUB OF THE CATHETER. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 8127046 ↗
• MalfunctionNov 27, 2018Break; Break

  IT WAS REPORTED THAT DURING PRODUCT TESTING, UPON OPENING OF THE RECANALIZATION CATHETER PACKAGING, THE HUB WAS ALLEGEDLY FOUND BROKEN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8108474 ↗
• MalfunctionNov 16, 2018Material Separation; Device Dislodged or Dislocated; Material Twisted/Bent; Material Separation; Device Dislodged or Dislocated; Material Twisted/Bent

  IT WAS REPORTED THAT THE DISTAL TIP OF THE RECANALIZATION CATHETER ALLEGEDLY SEPARATED FROM THE CATHETER BUT REMAINED ATTACHED TO THE CORE WIRE. IT WAS FURTHER REPORTED THAT 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 8081947 ↗
• MalfunctionNov 6, 2018Material Puncture/Hole; Material Split, Cut or Torn; Material Puncture/Hole; Material Split, Cut or Torn

  IT WAS REPORTED DURING PREPARATION OF THE RECANALIZATION CATHETER, A HOLE WAS ALLEGEDLY IDENTIFIED ON THE CATHETER. 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 8043898 ↗