N/A (REF D087031)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613327376067), received between May 1, 2024 and Jan 8, 2026 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJan 8, 2026Use of Device Problem

  IT WAS REPORTED THAT AFTER A PFA ATRIAL FIBRILLATION ABLATION A PATIENT HAD A RETROPERITONEAL "BLEED". DURING THE PROCEDURE THE PHYSICIAN FELT THE ICE CATHETER WAS ADVANCING INCORRECTLY. THERE WAS TORTUOUS VASCULATURE. THE PHYSICIAN PERFORMED A CONTRAST IMAGE OF THE IVC PRIOR TO TRANSEPTAL AND IT REVEALED NO ISSUES. THE PATIENT PRESSURES WERE STABLE THROUGHOUT THE PROCEDURE. THE PHYSICIAN PERFORMED A REPEAT CONTRAST IMAGE OF THE IVC POST PROCEDURE, AND IT REVEALED NO BLEED. AFTER THE PROCEDURE THE PATIENTS¿ BLOOD PRESSURE DROPPED AND A CT REVEALED AN RP BLEED. THE PATIENT RECOVERED. THE SUSPECTED CATHETER WAS THE VIEW FLEX ICE CATHETER. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION. NO INFORMATION WAS PROVIDED REGARDING PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: Retroperitoneal Hemorrhage

  MAUDE report 24004590 ↗
• InjuryJul 2, 2025Use of Device Problem; Insufficient Device Problem Information; Use of Device Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT FOLLOWING A PFA PROCEDURE, A PERICARDIAL EFFUSION OCCURRED WHICH REQUIRED SURGERY TO REPAIR THE PERFORATION. THE PROCEDURE HAD GONE WELL, PVI TO FIND A HIS ELECTROGRAM AND PACE IN THE RIGHT VENTRICLE (RV) WITH A GOOD OUTCOME FROM THE PVI POINT. A FEW HOURS POST-PROCEDURE WHILE IN RECOVERY, A PERICARDIAL EFFUSION WAS DIAGNOSED. SURGERY WAS PERFORMED TO REPAIR THE PERFORATION IN THE RIGHT ATRIUM. AS REPORTED, THE PATIENT WAS STABLE AND RECOVERING IN THE ICU. THE PHYSICIAN THINKS THE PERFORATION MAY HAVE BEEN CAUSED BY THE VIEWFLEX ICE CATHETER WHICH WAS REPROCESSED BY STRYKER. THERE WAS NO OTHER PATIENT INJURY OR MEDICAL INTERVENTION REPORTED AND NO EXTENDED PROCEDURE TIME WAS REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: Cardiac Perforation; Pericardial Effusion

  MAUDE report 22383928 ↗
• MalfunctionMay 22, 2024

  THE PATIENT WAS TORTUROUS, SO CATH TEAM UPSIZED TO 12FR X 30CM FROM 10FR X 23CM. PROCEDURALIST PUT THE CATHETER UP THE IVC (INFERIOR VENA CAVA), REMARKED ON THE IMAGE, AND THEN WHEN HE TORQUED THE CATHETER TO ENTER THE RIGHT ATRIUM, ULTRASOUND IMAGE WAS LOST. CATH TEAM PULLED THE CATHETER OUT AND UPON INSPECTION THE TIP WAS BROKEN AT A 45-DEGREE ANGLE TO THE CATHETER SHAFT WITH A VISIBLE SPLIT. MANUFACTURER RESPONSE FOR REPROCESSED INTRAVASCULAR ULTRASOUND CATHETER, N/A (PER SITE REPORTER). STRYKER DID PHONE CONFERENCE WITH HOSPITAL TO ADVISE OF STEPS THEY ARE TAKING TO INVESTIGATE CONCERN.

  Patient problems: Insufficient Information

  MAUDE report 19369665 ↗
• MalfunctionMay 1, 2024

  REPROCESSED ICE (INTRACARDIAC ECHOCARDIOGRAPHY) CATHETER INSERTED INTO THE PATIENT VIA 10 FRENCH SHEATH IN THE LEFT FEMORAL VEIN. DEVICE HAD IMAGERY ON THE MONITOR, AND PROCEDURALIST NOTED THAT THE IMAGE WAS POOR. PROCEDURALIST DID FLUORO OF THE DEVICE AND NOTED THAT THE TIP OF THE ICE CATHETER WAS AT AN ACUTE NON-NORMAL ANGLE AND WAS MOVING UNDER FLUORO. DEVICE WAS RETRIEVED WITH NO PATIENT HARM AND PROCEDURE CONTINUED WITH A NEW DEVICE. MANUFACTURER RESPONSE FOR REPROCESSED INTRAVASCULAR ULTRASOUND CATHETER (PER SITE REPORTER). VENDOR REP WOULD LIKE TO PICK ITEM UP FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19219978 ↗