OPTRELL Mapping Catheter with TRUEref Technology D142902Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10846835025811), received between Jan 3, 2025 and Jan 27, 2026 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Entrapment of Device” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 27, 2026Manufacturing, Packaging or Shipping Problem; Material Protrusion/Extrusion

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ISCHEMIC VENTRICULAR TACHYCARDIA (ISVT) ABLATION PROCEDURE WITH AN OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY AND PRIOR TO BEING INSERTED INTO THE BODY, THE CATHETER COATING WAS COMING OFF AND WIRES AND HARDWARE WERE EXPOSED. THE CATHETER WAS REPLACED AND THE PROCEDURE CONTINUED. THE REPORTER STATED THAT THE FAULTY CATHETER WAS BRAND NEW. A REPLACEMENT CATHETER WAS REQUESTED. THE REPORTER STATED THAT THE NGEN GENERATOR WAS USED FOR ABLATION. THERE WAS NO ADVERSE PATIENT CONSEQUENCE REPORTED. ADDITIONAL INFORMATION INDICATED THAT THE ISSUE WAS FOUND NEAR THE PADDLE COMPONENT OF THE OPTRELL. THE CATHETER WAS NOT INSERTED THROUGH A SHEATH. THE DAMAGE WAS NOTED WHEN THE CATHETER WAS REMOVED FROM PACKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24186663 ↗
• InjuryJul 3, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) CARDIAC ABLATION WITH AN OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY AND PRIOR TO ABLATION ENERGY DELIVERY, THE PATIENT EXPERIENCED A PERICARDIAL EFFUSION THAT REQUIRED DRAINAGE AND PROLONGED HOSPITALIZATION. DURING A CARDIAC ABLATION PROCEDURE, PRIOR TO ABLATION ENERGY DELIVERY, THE PATIENT HAD A PERICARDIAL EFFUSION. THIS WAS NOTED AFTER THEY WENT TRANSSEPTAL WITH THE VERSACREST WIRE. THE OPTRELL CATHETER WAS IN THE LEFT ATRIUM FOR MAPPING TO CONFIRM WHERE THEY WERE AND NOTICED SOME PERICARDIAL FLUID IN THE RIGHT VENTRICLE. THE PERICARDIAL FLUID WAS CONFIRMED ON INTRACARDIAC ECHOCARDIOGRAPHY (ICE) AND X-RAY. AT THIS POINT, THE PHYSICIAN ABORTED THE PROCEDURE AND PROVIDED MEDICAL INTERVENTION BY DRAINING THE PERICARDIAL FLUID FROM AROUND THE HEART BY DOING PERICARDIOCENTESIS. AFTER THE PERICARDIAL FLUID WAS DRAINED, THE PATIENT REMAINED STABLE WHICH WAS ALSO THE LAST KNOWN STATUS. THE CASE WAS ABORTED. ADDITIONAL INFORMATION WAS RECEIVED INDICATED THAT THE VERSACROSS WIRE WAS USED TO CROSS THE SEPTUM, BUT IT HAS NOT BEEN DETERMINED WHAT CAUSED THE EFFUSION. THE ADVERSE EVENT WAS DISCOVERED DURING USE OF BI

  Patient problems: Cardiac Tamponade

  MAUDE report 22394875 ↗
• MalfunctionJun 9, 2025Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VENTRICULAR TACHYCARDIA (VT) CARDIAC ABLATION PROCEDURE WITH A OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY AND THE DEVICE GOT TANGLED WITH AN IMPELLA. THIS OCCURRED WHILE THE IMPELLA WAS IN USE DURING THE PROCEDURE AND THE OPTRELL WAS BEING USED FOR MAPPING. THE IMPELLA BECAME STUCK IN THE GRID. THE PHYSICIAN WAS ABLE TO PULL THE CATHETER OUT WITHOUT SURGICAL INTERVENTION. THE PHYSICIAN USED "PATIENCE AND HAND MOVEMENTS" TO UNTANGLE THE DEVICE. THERE WAS NO MALFUNCTION NOTED WITH THE CATHETER. NO COMPONENTS BECAME DETACHED. NO FURTHER DETAILS WERE PROVIDED REGARDING COMPLETION OF THE PROCEDURE. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22170492 ↗
• MalfunctionMay 27, 2025Entrapment of Device; Material Twisted/Bent; Entrapment of Device; Material Twisted/Bent

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ISVT CARDIAC ABLATION PROCEDURE WITH A OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY AND THE DEVICE WAS STUCK IN THE 8.5 FR. TERUMO SHEATH INSIDE THE PATIENT'S FEMORAL ARTERY. IT WAS FOLDED BACK ON ITSELF AND THE PHYSICIAN WAS UNABLE TO RETRACT IT FROM THE PATIENT. THE ISSUE OCCURRED AS THE CATHETER WAS PROLAPSED IN THE LEFT VENTRICLE (LV) INTENTIONALLY. THE MEDICAL TEAM PULLED CATHETER BACK AND WHEN TRYING TO UN-PROLAPSE AND PULLING BACK, IT WAS PULLED BACK TOO FAR AND BECAME STUCK IN THE SHEATH. THE PHYSICIAN CUT THE HANDLE OFF THE CATHETER, EXCHANGED SHEATHS AND THEY WERE ABLE TO UN-PROLAPSE THE CATHETER AND PULL IT BACK INTO THE SHEATH AND REMOVE IT FROM THE PATIENT WITHOUT INJURY. THERE WAS NO INTERNAL PARTS EXPOSED. THERE WERE NO DETACHMENTS OR SHARP EDGES NOTED. THE MEDICAL TEAM OPENED A NEW OPTRELL TO CONTINUE THE CASE SUCCESSFULLY TO COMPLETION. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22091941 ↗
• MalfunctionJan 3, 2025Entrapment of Device; Material Twisted/Bent; Entrapment of Device; Material Twisted/Bent

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ISCHEMIC VENTRICULAR TACHYCARDIA (ISVT) ABLATION PROCEDURE WITH AN OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY AND THE CATHETER GOT STUCK IN THE PIGTAIL OF THE IMPELLA. IT WAS NOT POSSIBLE TO PULL IT OUT. THE PIGTAIL BROKE OFF WHEN THE IMPELLA WAS PULLED. THIS CAN BE EASILY REMOVED FROM THE ILIAC ARTERY. THE OPTRELL WAS REMOVED FROM THE PATIENT AND THE ABLATION WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT NO SURGICAL INTERVENTION WAS REQUIRED TO REMOVE THE OPTRELL CATHETER. NO OTHER DEVICE WAS USED TO REMOVE THE OPTRELL CATHETER. AFTER REMOVING THE OPTRELL THERE WAS PHYSICAL DAMAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21068837 ↗