CROSSER® CRU14SARecalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 10801741125567), received between Oct 11, 2016 and Mar 24, 2022 — classified as 20 malfunctions.

The most frequently reported specific device problem is “Material Separation” (8 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 24, 2022Melted; Device-Device Incompatibility; Material Deformation; Melted; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT DURING A RECANALIZATION PROCEDURE THROUGH THE SUPERFICIAL FEMORAL ARTERY, THE CATHETER WAS ALLEGEDLY JAMMED ON TO THE GUIDEWIRE. IT WAS FURTHER REPORTED THAT THE CATHETER MELTED ON WIRE. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13892737 ↗
• MalfunctionFeb 17, 2022Melted; Material Puncture/Hole; Device-Device Incompatibility; Melted; Material Puncture/Hole; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A RECANALIZATION PROCEDURE IN A PERIPHERAL ARTERIAL DISEASE OF SUPERFICIAL FEMORAL ARTERY, THE CATHETER WAS ALLEGEDLY JAMMED ON TO THE GUIDEWIRE. IT WAS FURTHER REPORTED THAT THE CATHETER WAS ALLEGEDLY MELTED. THE PROCEDURE WAS COMPLETED USING WIRE ESCALATION TECHNIQUE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13547425 ↗
• MalfunctionAug 31, 2021Melted; Material Separation; Melted; Material Separation

  IT WAS REPORTED THAT DURING A PROCEDURE, THE WIRE WAS ALLEGEDLY MELTED INTO CATHETER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12391394 ↗
• MalfunctionAug 5, 2021Melted; Melted

  IT WAS REPORTED THAT DURING A PROCEDURE, THE WIRE WAS ALLEGEDLY MELTED INTO CATHETER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12279094 ↗
• MalfunctionApr 26, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT DURING DURING A RECANALIZATION PROCEDURE, THE TIP OF THE CATHETER ALLEGEDLY SEPARATED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11722878 ↗
• MalfunctionDec 19, 2018Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING TREATMENT OF CALCIFIED LESION, THE RECANALIZATION CATHETER ALLEGEDLY OVERHEATED. REPORTEDLY, THE RECANALIZATION CATHETER WAS REMOVED FROM THE PATIENT WITHOUT ANY ISSUE. IT WAS FURTHER REPORTED THAT CATHETER AND GUIDEWIRE WERE USED TO CROSS THE LESION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8180117 ↗
• MalfunctionOct 2, 2018Fracture; Material Puncture/Hole; Material Deformation; Fracture; Material Puncture/Hole; Material Deformation

  IT WAS REPORTED THAT UPON REMOVAL OF THE RECANALIZATION CATHETER FROM THE FEMORAL ARTERY, A PORTION OF THE CATHETER WAS ALLEGEDLY STICKING OUT AND A BEND WAS ALLEGEDLY IDENTIFIED. NO FURTHER TREATMENT WAS PERFORMED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7927466 ↗
• MalfunctionAug 15, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT AFTER APPROXIMATELY ONE MINUTE AND THIRTY-SIX SECONDS OF ACTIVATION IN THE SFA, THE TIP OF THE RECANALIZATION CATHETER ALLEGEDLY DETACHED. REPORTEDLY, A STRAIGHT FLUSH CATHETER AND GUIDEWIRE WERE USED TO RETRIEVED THE TIP. IT WAS FURTHER REPORTED THAT WIRE AND CATHETER WERE USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7787595 ↗
• MalfunctionJul 6, 2018Break; Leak/Splash; Break; Leak/Splash

  IT WAS REPORTED THAT DURING THE SALINE FLUSH PORTION OF THE OUT OF BODY TEST FOR A RECANALIZATION CATHETER, AN ALLEGED LEAK WAS NOTED AND A BREAK WAS FOUND AT THE DISTAL END OF THE HANDLE. REPORTEDLY, ANOTHER RECANALIZATION CATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 7668173 ↗
• MalfunctionJun 27, 2018Break; Leak/Splash; Break; Leak/Splash

  IT WAS REPORTED THAT DURING THE SALINE FLUSH PORTION OF THE OUT OF BODY TEST FOR A RECANALIZATION CATHETER, THE DISTAL END OF THE Y-BODY ALLEGEDLY LEAKED SALINE AND A CRACK WAS IDENTIFIED ON THE Y-BODY. REPORTEDLY, ANOTHER RECANALIZATION CATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 7643876 ↗
• MalfunctionMay 3, 2018Overheating of Device; Device-Device Incompatibility; Material Twisted/Bent; Overheating of Device; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT DURING TREATMENT OF THE RIGHT TIBAL ARTERY, THE RECANALIZATION CATHETER ALLEGEDLY OVER HEATED AND MELTED THE CATHETER. IT WAS FURTHER REPORTED THAT THE GUIDEWIRE BECAME LODGED WITHIN THE RECANALIZATION CATHETER. THE HEALTH CARE PROVIDER (HCP) HAD TO REMOVE THE RECANALIZATION CATHETER AND GUIDEWIRE TOGETHER AS A SINGLE UNIT. REPORTEDLY, ANGIOPLASTY WAS PERFORMED AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7483832 ↗
• MalfunctionSep 27, 2017Material Separation; Device Inoperable; Material Deformation; Material Separation; Device Inoperable; Material Deformation

  IT WAS REPORTED THAT DURING THE OUT OF BODY TEST, THE RECANALIZATION CATHETER ALLEGEDLY WOULD NOT VIBRATE OR MIST, RENDERING THE DEVICE UNUSABLE. REPORTEDLY, ANOTHER RECANALIZATION CATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 6899705 ↗
• MalfunctionSep 20, 2017Hole In Material; Material Separation; Device-Device Incompatibility; Hole In Material; Material Separation; Device-Device Incompatibility

  IT WAS REPORTED THAT THE RECANALIZATION CATHETER ALLEGEDLY WOULD NOT LOAD ONTO THE GUIDEWIRE, RENDERING THE DEVICE UNUSABLE. REPORTEDLY, ANOTHER GUIDEWIRE AND BALLOON CATHETER WERE USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 6879938 ↗
• MalfunctionJul 10, 2017Fracture; Kinked; Material Separation; Fracture; Kinked; Material Separation

  IT WAS REPORTED THAT THE DISTAL TIP OF THE RECANALIZATION CATHETER ALLEGEDLY SEPARATED FROM THE CATHETER BUT REMAINED ATTACHED TO THE CORE WIRE AFTER THREE MINUTES OF ACTIVATION IN THE SFA. REPORTEDLY, THE HEALTH CARE PROVIDER (HCP) WITHDREW THE GUIDEWIRE TOO FAR BACK DURING TREATMENT AND HAD TO REMOVE THE GUIDEWIRE AND CATHETER. UPON REMOVAL, IT WAS NOTICED BY THE HCP THAT THE DISTAL TIP ALLEGEDLY SEPARATED FROM THE CATHETER. 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 6699816 ↗
• MalfunctionJul 10, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE DISTAL TIP OF THE RECANALIZATION CATHETER ALLEGEDLY DETACHED IN THE MID SFA AFTER 4.5 MINUTES OF ACTIVATION. IT WAS FURTHER REPORTED THAT THE HEALTH CARE PROVIDER DECIDED TO LEAVE THE DETACHED TIP IN SITU AS THERE WAS NO POTENTIAL HEALTH HAZARD TO THE PATIENT. REPORTEDLY, THE HEALTH CARE PROVIDER EXCHANGED THE RECANALIZATION CATHETER OVER THE GUIDEWIRE FOR ANOTHER AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6699763 ↗
• MalfunctionMay 8, 2017Break; Crack; Leak/Splash; Break; Crack; Leak/Splash

  IT WAS REPORTED THAT DURING THE OUT OF BODY TEST PROCESS, THE RECANALIZATION CATHETER ALLEGEDLY LEAKED FROM THE HUB; RENDERING THE DEVICE UNUSABLE. REPORTEDLY, ANOTHER RECANALIZATION CATHETER WAS USED TO PERFORM THE PROCEDURE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 6552939 ↗
• MalfunctionDec 27, 2016Material Puncture/Hole; Device-Device Incompatibility; Material Puncture/Hole; Device-Device Incompatibility

  IT WAS REPORTED THAT THE RECANALIZATION CATHETER ALLEGEDLY BECAME STUCK ON THE GUIDEWIRE DURING USE IN THE RIGHT POSTERIOR TIBIAL. THE RECANALIZATION CATHETER AND THE GUIDEWIRE WERE REMOVED TOGETHER AS A SINGLE UNIT FROM THE PATIENT AND ACCESS WAS LOST AT THE LESION SITE. REPORTEDLY, THE PROCEDURE WAS COMPLETED WITH ANOTHER GUIDE WIRE AND CATHETER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6207534 ↗
• MalfunctionDec 13, 2016Material Separation; Device-Device Incompatibility; Material Separation; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING TREATMENT IN THE SFA, THE GUIDEWIRE WAS ALLEGEDLY UNABLE TO LOAD THROUGH THE RECANALIZATION CATHETER; THEREFORE, ANOTHER RECANALIZATION CATHETER AND A SUPPORT CATHETER WERE USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6171919 ↗
• MalfunctionDec 2, 2016Material Puncture/Hole; Material Separation; Material Puncture/Hole; Material Separation

  IT WAS REPORTED THAT DURING TREATMENT IN THE SFA, THE DISTAL TIP OF THE RECANALIZATION CATHETER WAS ALLEGEDLY PARTIALLY SEPARATED FROM THE CATHETER CORE WIRE LUMEN. IT WAS FURTHER REPORTED THAT THE CATHETER WAS RETRACTED WITHOUT INCIDENT. 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 6142910 ↗
• MalfunctionOct 11, 2016Material Separation; Device-Device Incompatibility; Material Separation; Device-Device Incompatibility

  IT WAS REPORTED THAT THE RECANALIZATION CATHETER ALLEGEDLY BECAME STUCK ON THE GUIDEWIRE DURING USE IN THE LEFT ANTERIOR TIBIAL; THEREFORE, THE CATHETER AND GUIDEWIRE WERE REMOVED AS A SINGLE UNIT, RESULTING IN LOSS OF ACCESS SITE. REPORTEDLY, ANOTHER WIRE AND RECANALIZATION CATHETER WAS 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 6016935 ↗