OPTRELL D140902Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10846835023022), received between Jun 23, 2023 and Aug 21, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Body Fluid” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 21, 2023Device Contamination with Body Fluid; Device Contamination with Body Fluid

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH AN OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY AND CLOTTING FORMED ON THE PADDLE. THE PHYSICIAN NOTICED THAT WHEN THE CATHETER WAS PULLED OUT OF THE PATIENT, CLOTTING HAD FORMED ON THE PADDLE OF THE OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY. NO PATIENT CONSEQUENCE WAS REPORTED. ADDITIONAL INFORMATION WAS RECEIVED. A CLOT WAS CONFIRMED FOUND ON THE CATHETER. IT WAS UNKNOWN IF AN ABLATION CATHETER WAS USED DURING THIS PROCEDURE. THE SYSTEM DID NOT PRESENT ANY ERROR MESSAGES NOR DID THE PHYSICIAN/USER SEE ANY PRODUCT PROBLEM. THERE WERE NO ISSUES RELATED TO TEMPERATURE AND FLOW ON THE CATHETER. THE GENERATOR WAS SET TO POWER CONTROL MODE AT 50 W. THE TEMPERATURE, IMPEDANCE AND POWER WERE NOT NOTED. THE PATIENT WAS ANTICOAGULATED. THIS PRACTICE MAINTAINS AN ACT OF ~250-300 THROUGHOUT THE CASE. NOT AWARE IF THE PATIENT EXHIBITED ANY NEUROLOGICAL SYMPTOMS SINCE THE PROCEDURE WAS COMPLETED. CORRECT CATHETER SETTINGS WERE SELECTED ON THE GENERATOR. THE PUMP WAS SWITCHING FROM LOW TO HIGH FLOW DURING ABLATION. THE AVERAGE CONTACT FORCE WAS NOT GREATER THAN 40 GRAMS. IRRIGATION RATE WAS NOT USED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17591729 ↗
• MalfunctionJun 30, 2023Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ISCHEMIC VENTRICULAR TACHYCARDIA (ISVT) ABLATION PROCEDURE WITH A OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY AND A MEDICAL DEVICE ENTRAPMENT (NO EXCESSIVE MANIPULATION REQUIRED) ISSUE OCCURRED. IT WAS REPORTED THAT WHILE DOING AN EARLY EVALUATION STUDY, THE OPTRELL CATHETER BECAME ENTANGLED WITH AN IMPELLA DEVICE IN THE PATIENT'S LEFT VENTRICLE. THEY WERE ABLE TO ADVANCE THE IMPELLA DEVICE AND UNDEFLECT AND WITHDRAW THE OPTRELL CATHETER. THE PATIENT WAS STABLE. THEY CONTINUED THE CASE USING AN OCTARAY CATHETER. THE CASE CONTINUED WITHOUT ANY FURTHER INCIDENT. THE PHYSICIAN STATED THEY WOULD NOT BE USING THE OPTRELL CATHETER IN THE FUTURE WITH A PATIENT THAT HAS AN IMPELLA DEVICE. THERE WAS DIFFICULTY MANEUVERING CATHETER WHILE ENTANGLED. THE DEVICE WAS ABLE TO BE WITHDRAWN WHEN IMPELLA WAS ADVANCED. THERE WAS NO DETACHMENT OF ANY COMPONENT. THE LOOP/TIP WAS NOT KNOTTED, JUST ENTANGLED. THEY WERE ABLE TO REMOVE THE OPTRELL SAFELY WITH IMPELLA STILL IN PLACE. THE ISSUE DID NOT RESULT IN EXPOSURE OF ANY INTERNAL CATHETER COMPONENTS OR SHARP EDGES. THERE WAS NO PATIENT CONSEQUENCE. THE MEDICAL DEVICE ENTRAPMENT (NO EXCESSIVE MANIPULATIO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17238320 ↗
• MalfunctionJun 23, 2023Display or Visual Feedback Problem; Device Contamination with Body Fluid; Display or Visual Feedback Problem; Device Contamination with Body Fluid

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN IDVT ABLATION PROCEDURE WITH AN OPTRELL CATHETER AND THE CARTO 3 SYSTEM WAS UNABLE TO VISUALIZE THE SPLINES OF THE OPTRELL CATHETER. THE MEDICAL TEAM COULD ONLY SEE THE SHAFT OF THE CATHETER AFTER MAPPING THE RIGHT VENTRICLE. THEY TRIED RESEATING THE CATHETER WITH NO RESOLUTION. THEY SWITCHED TO THE ABLATION CATHETER TO CONTINUE MAPPING AND CONTINUED THE PROCEDURE. NO PATIENT CONSEQUENCES WERE REPORTED. AFTER THE PROCEDURE, IT WAS NOTICED THAT THE ELECTRODES ON THE OPTRELL CATHETER WERE BLACK ON THE CARTO 3 SYSTEM. THEY HAD HEPARINIZED THE PATIENT RIGHT BEFORE THEY WENT TO THE LEFT SIDE OF THE HEART WHEN THEY NOTICED THE BLACK ELECTRODES. THE OPTRELL CATHETER REMAINED IN THE RIGHT ATRIUM AFTER THE BLACK ELECTRODES WERE NOTICED AND WAS NOT USED AGAIN FOR THE REST OF THE PROCEDURE. AFTER THE PROCEDURE, UPON INSPECTION OF THE OPTRELL CATHETER AFTER BEING TAKEN OUT OF THE BODY, THEY NOTICED COAGULATION ON THE SAME ELECTRODES THAT WERE SHOWING UP BLACK ON THE CARTO 3 SYSTEM. VISUALIZATION ISSUE IS NOT MDR-REPORTABLE. THROMBUS/CLOT IS MDR-REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17192843 ↗