Reprocessed DECANAV EP Catheter, F Curve RR7F282CTRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10888551045704), received between Nov 3, 2025 and Feb 6, 2026 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (1 report).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 6, 2026Contamination /Decontamination Problem; Physical Resistance/Sticking

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SUPRAVENTRICULAR TACHYCARDIA PROCEDURE WITH A REPROCESSED DECANAV EP CATHETER, F CURVE CATHETER AND OBSERVED MATERIAL AT THE TIP OF THE CATHETER. THE PHYSICIAN FELT LIKE THE DECANAV CATHETER WAS NOT MANEUVERING SMOOTHLY. WHEN THE DECANAV CATHETER WAS REMOVED FROM THE BODY, THE CATHETER SEEMED ROUGH AT THE TIP OF THE CATHETER. THE DECANAV CATHETER WAS REPLACED AND THE PROCEDURE CONTINUED. THE FAULTY DECANAV CATHETER WAS REPROCESSED BY STERILMED INC. THERE WAS NO PATIENT CONSEQUENCE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED ON 21-NOV-2025 WHICH CORRECTED THAT THE DEVICE RECEIVED AT THE BIOSENSE WEBSTER, INC. (BWI) PRODUCT ANALYSIS LAB MUST BE THE BWI DECANAV CATHETER THAT HAD THE ISSUE AS THERE WERE NO OTHER DECANAV CATHETER¿S CALLED IN FROM THIS ACCOUNT IN THE LAST 30 DAYS. ADDITIONAL INFORMATION WAS RECEIVED ON 24-NOV-2025. THE DAMAGE DID NOT RESULT IN WIRES BEING EXPOSED. THE DAMAGE DID NOT RESULT IN ANY LIFTED OR SHARP RINGS. THERE WAS RESISTANCE ON REMOVAL SLIGHTLY. TISSUE WAS FOUND ON THE VERY DISTAL TOP OF THE CATHETER. THE SHEATH USED WAS AN 8FR PINNACLE SHEATH. ADDITIONAL INFORMATION WAS RECEIVED ON 04-DEC-2025. THE PHYSICIAN FE

  Patient problems: Unspecified Tissue Injury

  MAUDE report 24280555 ↗
• InjuryNov 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PVC / IDIOPATHIC VENTRICULAR TACHYCARDIA - (IDVT) PROCEDURE WITH A REPROCESSED DECANAV EP CATHETER, F CURVE AND SUFFERED A PERICARDIAL EFFUSION WHICH REQUIRED A PERICARDIOCENTESIS. DURING THE PROCEDURE, A PERICARDIAL EFFUSION WAS NOTICED. AFTER THE PROCEDURE, AFTER ALL THE CATHETERS HAD ALREADY BEEN REMOVED FROM THE BODY, ANESTHESIA NOTICED THERE WAS A DROP IN BLOOD PRESSURE ON THE PATIENT. SINCE ALL THE CATHETERS HAD BEEN REMOVED, THE PHYSICIAN USED AN ACCESS PROBE TO CHECK THE CHEST FOR A PERICARDIAL EFFUSION. THE PERICARDIAL EFFUSION WAS CONFIRMED BY AN ACCESS PROBE. THE MEDICAL INTERVENTION PROVIDED WAS PERICARDIOCENTESIS AND FLUID WAS STILL DRAINING FROM THE PATIENT AT THE TIME OF THE CALL. THE PATIENT WAS REPORTED TO BE IN AN UNKNOWN CONDITION. AT THE TIME OF THE CALL, IT WAS UNSURE IF THE PATIENT WAS STABLE OR IF THEY MAY NEED TO BE SENT INTO SURGERY. THE PHYSICIAN THINKS THE CORONARY SINUS (CS) CATHETER (DECANAV EP CATHETER, F CURVE) WAS INSERTED TOO FAR INTO THE CS AND POTENTIALLY WAS PUSHED TOO FAR AND PERFORATED. THE CALLER STATED WHEN THE CS WAS PULLED OUT, IT WOULD HAVE CREATED A HOLE WHICH CAUSED THE PERICARDIAL EFFUSION. MUL

  Patient problems: Cardiac Tamponade; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23590424 ↗
• InjuryNov 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION PROCEDURE WITH A REPROCESSED DECANAV EP CATHETER AND THE PATIENT EXPERIENCED A PERICARDIAL EFFUSION WHICH REQUIRED PERICARDIOCENTESIS. THE PHYSICIAN ATTEMPTED ABLATION INSIDE THE CORONARY SINUS (CS), BUT DUE TO DIFFICULT ANATOMY IT WAS ABORTED. THE PHYSICIAN ATTEMPTED BOTH SHEATH AND CATHETER MANIPULATION INSIDE THE CS FOR APPROXIMATELY 60 MINUTES. AFTER ABORTING THE ABLATION, A PERICARDIAL EFFUSION WAS DISCOVERED BY THE POST CASE INTRACARDIAC ECHOCARDIOGRAM (ICE) AND CONFIRMED BY ICE CATHETER. THE PHYSICIAN ATTEMPTED TO PERFORM PERICARDIOCENTESIS WHICH WAS ABORTED DUE TO INABILITY TO GAIN ACCESS TO THE PERICARDIAL SPACE, AND THE PHYSICIAN'S IMPRESSION OF THE EFFUSION DECREASING. THE PATIENT¿S CONDITION WORSENED AND THE PATIENT BEGAN SHOWING TAMPONADE PHYSIOLOGY LATER IN THE DAY AND WAS BROUGHT BACK TO THE LAB FOR PERICARDIOCENTESIS WHICH WAS SUCCESSFUL IN REMOVING 300ML OF FLUID. THE PATIENT WAS STABLE. LAST KNOWN STATUS OF THE PATIENT IS IMPROVED. THE PATIENT REQUIRED EXTENDED HOSPITALIZATION BECAUSE OF CONTINUED MONITORING. ONE TRANSSEPTAL PUNCTURE WAS PERFORMED WITH BAYLIS NRG. PRIOR TO NOTING THE PERICARD

  Patient problems: Cardiac Tamponade

  MAUDE report 23459236 ↗