NA RD134302Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10888551044806), received between Jan 19, 2021 and Nov 11, 2022 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Entrapment of Device” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 11, 2022Signal Artifact/Noise; Signal Artifact/Noise

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH A LASSO® 2515 ECO VARIABLE CATHETER, 10 POLES, 25-15 MM DIAMETER, 4F AND THE STERILMED PRODUCT ANALYSIS LAB OBSERVED AN ELECTRODE DAMAGED ISSUE. INITIALLY IT WAS REPORTED THAT THE ELECTRODES 1,2, 3, WERE REALLY NOISY. REPLACED THE CABLE AND IT DID NOT FIX THE ISSUE. REPLACED THE CATHETER AND HAD NO FURTHER ISSUES. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THE NOISE ISSUE WAS ASSESSED AS NOT MDR REPORTABLE. THE RISK TO THE PATIENT WAS LOW. THE STERILMED PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION AND PER THE EVALUATION COMPLETION ON 17-OCT-2022, THE ELECTRODE #2 WAS NO LONGER WELDED TO THE CATHETER TIP. IN ADDITION, THE TIP APPEARED TO BE CUT/TORN WITHOUT EXPOSED WIRES. ADDITIONAL CLARIFICATION WAS REQUESTED ON THE RETURNED CONDITION. A RESPONSE WAS RECEIVED STATING TO THEIR KNOWLEDGE, THE ELECTRODES WERE NEVER INSPECTED. THE ELECTRODE PAIR WAS NOISY FROM THE START. THE ELECTRODES WERE NOT INSPECTED DURING THE CASE. THEY THOUGHT THE NOISE TO BE A CABLING ISSUE. THE RETURNED CONDITION OF THE ELECTRODE #2 WAS NO LONGER WELDED TO THE CATHETER TIP WAS ASSESSED AS MDR REPORTABLE FOR AN ELEC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15785525 ↗
• InjuryJan 19, 2021Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT A FEMALE PATIENT (APPROXIMATELY (B)(6) YEARS OLD) UNDERWENT CARDIAC ABLATION PROCEDURE (ATRIAL FIBRILLATION) WITH LASSO® 2515 ECO VARIABLE CATHETER, AND SUFFERED DEVICE ENTRAPMENT REQUIRING ADDITIONAL INTERVENTION TO DISLODGE THE ENTRAPPED TIP. WHEN THE PHYSICIAN INSERTED THE LASSO CATHETER INTO THE LEFT ATRIUM AND JUST STARTED TO BUILD THE MAP, THE LASSO BECAME STUCK IN THE MITRAL ANNULUS. THE PHYSICIAN TRIED ROTATING COUNTERCLOCKWISE AND TRIED TO PLACE THE CATHETER IN THE SHEATH, BUT IT WOULD NOT RELEASE. THE CARDIOTHORACIC SURGEON CAME TO ASSIST, AND HE EVENTUALLY TOOK OVER. THE SURGEON MADE THE DECISION TO TUG REALLY HARD AND DISLODGE THE TIP FROM THE VALVE. MANIPULATION OF THE LASSO CATHETER CONTINUED IN A CLOCKWISE AND COUNTERCLOCKWISE MOTION, IN ORDER TO REMOVE THE CATHETER FROM THE MITRAL VALVE ANNULUS WITHOUT RESOLUTION. THE CATHETER WAS ALSO "TORQUED" BACK AND FORTH WITHOUT RESOLUTION. THE LASSO CATHETER WAS "TUGGED," AND THE CATHETER WAS PULLED FREE OF THE VALVE. AFTER THE CATHETER WAS REMOVED FROM THE BODY, THERE WAS NO MATERIAL OR TISSUE ATTACHED TO THE DISTAL END, AND THE ELECTRODES WERE "ALL IN PLACE." SURGERY WAS PROLONGED DUE TO THE EVENT; HOWE

  Patient problems: Rupture

  MAUDE report 11197348 ↗