NA RD087031Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10888551045216), received between Mar 18, 2021 and Aug 28, 2025 — classified as 1 injury, 14 malfunctions.

The most frequently reported specific device problem is “Break” (10 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 28, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION PROCEDURE WITH A REPROCESSED VIEWFLEX XTRA ICE CATHETER AND THE TIP OF THE CATHETER ¿FRACTURED¿ DURING THE PROCEDURE AND WAS PARTIALLY ATTACHED. THERE WERE NO EXPOSED OR PROTRUDING COMPONENTS. THE COMPLAINT DEVICE WAS REPLACED WITH A NEW DEVICE, THE PROCEDURE CONTINUED AND WAS SUCCESSFULLY COMPLETED WITH THE REPLACEMENT DEVICE. THERE WAS NO ISSUE WITH THE PATIENT¿S ANATOMY THAT MAY HAVE CONTRIBUTED TO THE FRACTURE AT THE DISTAL TIP. THERE WAS NO PATIENT INJURY OR CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22916160 ↗
• MalfunctionAug 15, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION PROCEDURE WITH A REPROCESSED VIEWFLEX XTRA ICE CATHETER AND DURING THE PROCEDURE, THE TIP OF THE CATHETER BROKE. THE DEVICE WAS ABLE TO BE REMOVED. THE TIP WAS STILL ATTACHED TO THE REST OF THE CATHETER BY THE INTERNAL COMPONENTS. THERE WAS NO PHYSICAL DAMAGE OR ANY OTHER ISSUE OBSERVED ON THE PACKAGE OF THE DEVICE. THERE WAS NO PATIENT CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22816378 ↗
• MalfunctionJul 25, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION PROCEDURE WITH A REPROCESSED VIEWFLEX XTRA ICE CATHETER AND WHEN IT WAS TAKEN OUT OF THE PACKAGE, THE TIP WAS CRACKED AND HANGING. THERE WAS NO PATIENT INJURY OR CONSEQUENCE. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN FURTHER INFORMATION ON THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS NOT BEEN MADE AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22609094 ↗
• MalfunctionFeb 1, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION PROCEDURE WITH A REPROCESSED VIEWFLEX XTRA ICE CATHETER AND THE WHEN THE PACKAGE WAS OPENED THE TIP WAS NOTED TO BE BROKEN OFF. THERE WAS NO PATIENT CONSEQUENCE. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION TO THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18624580 ↗
• InjuryAug 17, 2023Break; Patient Device Interaction Problem; Break; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FLUTTER PROCEDURE WITH A REPROCESSED VIEWFLEX XTRA ICE CATHETER. AT THE START OF THE PROCEDURE, THE INTRACARDIAC ECHOCARDIOGRAM (ICE) CATHETER WAS PLACED THROUGH A 9F 25CM PINNACLE SHEATH. THE PHYSICIAN DID NOT INSPECT TIP OF THE CATHETER BEFORE INSERTING IT INTO THE SHEATH, HOWEVER, NOTHING UNUSUAL WAS NOTICED PRIOR TO INSERTION. APPROXIMATELY FIVE SECONDS AFTER INSERTION, THE ICE IMAGE WENT BLACK. THE CATHETER WAS REMOVED, AND PHYSICIAN NOTED SOME OF THE TIP OF THE CATHETER WAS MISSING. UNDER FLUOROSCOPY INSPECTION, PART OF THE CATHETER TIP WAS SEEN TO BE LODGED IN A SMALL VENOUS SIDE BRANCH OF THE PATIENT¿S PELVIS REGION. THE PATIENT UNDERWENT AN ADDITIONAL INTERVENTIONAL RADIOLOGY PROCEDURE TO ATTEMPT TO REMOVE THE DETACHED PIECE, HOWEVER DECISION WAS MADE TO LEAVE THE PIECE IN THE VASCULATURE. THE PATIENT WAS REPORTED TO BE ASYMPTOMATIC FIVE DAYS POST PROCEDURE.

  Patient problems: Foreign Body In Patient

  MAUDE report 17569300 ↗
• MalfunctionAug 3, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE WITH A REPROCESSED VIEWFLEX XTRA ICE CATHETER. THE CATHETER WAS INSERTED INTO THE PATIENT VESSEL BY WAY OF SHEATH, AND THE TIP OF THE CATHETER WAS NOTICED TO BE CRACKED. THE DEVICE WAS REMOVED FROM THE PATIENT, AND IT WAS REPLACED WITH ANOTHER REPROCESSED VIEWFLEX XTRA ICE CATHETER. THERE WAS NO RESISTANCE OR DIFFICULTY DURING INSERTION OR REMOVAL OF THE CATHETER. THE REPLACEMENT DEVICE WAS INSPECTED ON THE TRAY, AND IT WAS NOTICED TO ALSO HAVE A CRACK IN THE SAME LOCATION AS THE FIRST DEVICE. THE SECOND DEVICE WAS NOT USED ON THE PATIENT. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17456103 ↗
• MalfunctionAug 3, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE WITH A REPROCESSED VIEWFLEX XTRA ICE CATHETER. THE CATHETER WAS INSERTED INTO THE PATIENT VESSEL BY WAY OF SHEATH, AND THE TIP OF THE CATHETER WAS NOTICED TO BE CRACKED. THE DEVICE WAS REMOVED FROM THE PATIENT, AND IT WAS REPLACED WITH ANOTHER REPROCESSED VIEWFLEX XTRA ICE CATHETER. THERE WAS NO RESISTANCE OR DIFFICULTY DURING INSERTION OR REMOVAL OF THE CATHETER. THE REPLACEMENT DEVICE WAS INSPECTED ON THE TRAY, AND IT WAS NOTICED TO ALSO HAVE A CRACK IN THE SAME LOCATION AS THE FIRST DEVICE. THE SECOND DEVICE WAS NOT USED ON THE PATIENT. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17454874 ↗
• MalfunctionApr 19, 2023Break; Mechanical Jam; Break; Mechanical Jam

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CRYO-ENSITE ABLATION PROCEDURE WITH A VIEWFLEX XTRA ICE CATHETER AND A BROKEN TIP ISSUE OCCURRED. WHEN THIS RE-STERILIZED VIEWFLEX XTRA ICE CATHETER WAS USED, IT WOULD NOT STEER AND HAD A SHARP ANGLE ON IT. THEY REMOVED IT FROM THE CASE, THE TIP WAS BROKEN. A BRAND NEW CATHETER WAS OPENED AND USED. NO KNOWN HARM TO THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED. THERE WAS NO SPECIFIC PROCEDURAL OR PATIENT CIRCUMSTANCE THAT CONTRIBUTED TO THE BREAK. NO FRAGMENTS WERE GENERATED. THE ISSUE DESCRIBED WITH THE STEERING WAS ASSESSED AS NON REPORTABLE FOR A STEERING DIFFICULT (DEFLECTION) ISSUE. THE POTENTIAL THAT THIS ISSUE COULD CAUSE OR CONTRIBUTE TO A DEATH, SERIOUS INJURY, OR OTHER SIGNIFICANT ADVERSE EVENT WAS REMOTE. THE MOST LIKELY CONSEQUENCE WAS A PROCEDURAL DELAY, IF THE DEVICE HAS TO BE REPLACED. THE ISSUE DESCRIBED THAT IT HAD A SHARP ANGLE ON IT WAS ASSESSED AS MDR REPORTABLE FOR A BROKEN TIP ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16773515 ↗
• MalfunctionMar 24, 2023Break; Output Problem; Sharp Edges

  MID 60¿S FEMALE WITH HISTORY OF PERSISTENT ATRIAL FIBRILLATION. PROCEDURE: ABLATION CRYO-ENSITE. STEERABLE CATHETER GETS RE-STERILIZED OUTSIDE THE HOSPITAL AT A COMPANY, STERILMED. WHEN THE RE-STERILIZED CATHETER WAS USED, IT WOULD NOT STEER AND HAD A SHARP ANGLE ON IT. WE REMOVED IT FROM THE CASE THE TIP WAS BROKEN. A BRAND NEW CATHETER WAS OPENED AND USED. NO KNOWN HARM TO PATIENT. MANUFACTURER RESPONSE FOR REPROCESSED INTRAVASCULAR ULTRASOUND CATHETER, NA (PER SITE REPORTER). WILL OBTAIN.

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

  MAUDE report 16609592 ↗
• MalfunctionOct 12, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PROCEDURE WITH A VIEWFLEX XTRA ICE CATHETER, AND A BROKEN TIP ISSUE OCCURRED. OPENED THE PACKAGE AND WENT TO PUT CATHETER IN THE BODY AND THE TIP OF THE VIEWFLEX XTRA ICE CATHETER WAS COMPLETELY BROKEN IN HALF. IT WAS NOTICED BEFORE INSERTING INTO THE PATIENT. THERE WAS NO PATIENT CONSEQUENCE. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION TO THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE. THE EVENT WAS ASSESSED AS MDR REPORTABLE FOR A BROKEN TIP ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15585174 ↗
• MalfunctionJul 7, 2022Break; Appropriate Device Problem Term/Code Not Available; Break; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PROCEDURE WITH A VIEWFLEX XTRA ICE CATHETER AND THE CATHETER TIP WAS BROKEN UPON OPENING PACKAGE. THERE WERE NO LIFTED OR SHARP RINGS. IN ADDITION, THERE WERE NO WIRES AND/OR BRAID BEING EXPOSED. THE PRIMARY PACKAGING BOX WAS NOT OPENED BEFORE THE SURGERY AND THERE WAS NO PHYSICAL DAMAGE OBSERVED ON DEVICE PACKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14950667 ↗
• MalfunctionApr 27, 2022Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH A VIEWFLEX XTRA ICE CATHETER AND THE TIP OF CATHETER BROKE WHEN BEING INSERTED INTO SHEATH. TIP WAS HANGING FROM THE END OF THE CATHETER. DEVICE NEVER ENTERED PATIENT. THERE WERE NO ISSUES WITH THE PACKAGING, AND IT WAS NOT OPENED UNTIL THE CATHETER WAS TO GO INTO THE BODY. NO DAMAGE WAS SEEN WITH THE DEVICE BEFORE INSERTION. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14223219 ↗
• MalfunctionMar 3, 2022Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION PROCEDURE WITH A REPROCESSED VIEWFLEX XTRA ICE CATHETER AND THE TIP OF CATHETER WAS BROKEN. WHEN THE CATHETER WAS REMOVED FROM THE PACKAGING, THE BROKEN TIP WAS DISCOVERED. THERE WERE NO LIFTED OR SHARP RINGS, HOWEVER THERE WAS WIRES AND/OR BRAID EXPOSED. NO FRAGMENTS WERE GENERATED. THERE WAS NO SPECIFIC PROCEDURAL OR PATIENT CIRCUMSTANCE THAT CONTRIBUTED TO THE ISSUE. THE PROCEDURE WAS COMPLETED WITH NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13660772 ↗
• MalfunctionJan 5, 2022Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE WITH A VIEWFLEX XTRA ICE CATHETER AND THE CATHETER WAS DEFECTIVE UPON OPENING AS THE TIP WAS BROKEN. THERE WAS NO PATIENT CONSEQUENCE. ON 14-DEC-2021, ADDITIONAL INFORMATION WAS RECEIVED THAT THE CATHETER TIP WAS COMPLETELY SNAPPED AT THE CRYSTAL. THE AWARENESS DATE WAS RESET TO 14-DEC-2021, THE DATE INFORMATION WAS RECEIVED THAT A REPORTABLE EVENT OCCURRED. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION TO THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13170192 ↗
• MalfunctionMar 18, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABLATION PROCEDURE WITH A VIEWFLEX XTRA ICE CATHETER AND A BROKEN TIP OCCURRED. THE CATHETER WAS REMOVED. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11520720 ↗