NA BIOBD710FJ282CTRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10888551005944), received between Mar 15, 2023 and Mar 7, 2024 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Break” (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 16, 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.

• MalfunctionMar 7, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ATRIAL FIBRILLATION PROCEDURE WITH A REPROCESSED EZ STEER BI-DIRECTIONAL CS CATHETER, THE TIP BROKE WHILE ENTERING THE SHEATH. THE CATHETER DID NOT SEPARATE INTO TWO OR MORE PIECES, HOWEVER, THERE WAS WIRES/BRAID EXPOSED. THERE WAS NO PHYSICAL DAMAGE, OR ANY OTHER ISSUE OBSERVED ON THE PACKAGE OF THE DEVICE. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18858050 ↗
• InjuryApr 12, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A CATHETER EZ STEER BI-DIRECTIONAL CS DEFECTABLE CURVE TYPE: F-J 12 PIN AUTO ID. THE PATIENT SUFFERED A CARDIAC TAMPONADE REQUIRING A PERICARDIOCENTESIS. IT WAS REPORTED THAT THE PROCEDURE WAS COMPLETELY STOPPED DUE TO THE PATIENT HAVING A PERICARDIAL EFFUSION. THEY STATED THAT THEY CROSSED INTO THE LEFT ATRIUM AND MAPPED. THE PHYSICIAN NOTICED THAT THERE WAS AN EFFUSION PRESENT IN AN UNKNOWN LOCATION. THE PROCEDURE WAS STOPPED AND A PERICARDIOCENTESIS WAS PERFORMED. THE THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER, OCTARAY, GALAXY, 48P, 3-3-3-3-3, D-CURVE, REPROCESSED SOUNDSTAR ECO CATHETER (LOT #2189176), REPROCESSED CS CATHETER (PREMIER PLURAL), AND A VIZIGO SHEATH WERE REMOVED FROM THE PATIENT'S BODY. THE PATIENT WAS NOT STABLE AT THAT TIME AND THEY DID NOT KNOW THE PATIENT'S PROGNOSIS AT THAT TIME. THE PHYSICIAN HAD CALLED CT SURGERY FOR A CONSULT. THEY ALSO STATED THAT THE PHYSICIAN DID NOT KNOW WHAT CAUSED THE EFFUSION. ADDITIONAL INFORMATION WAS RECEIVED STATING NO ABLATION WAS CARRIED OUT IN THE PROCEDURE AND THE EVENT OCCURRED DURING THE MAPPING PHASE. MULTIPLE

  Patient problems: Cardiac Tamponade

  MAUDE report 16724224 ↗
• MalfunctionMar 15, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH A CATHETER EZ STEER BI-DIRECTIONAL CS DEFECTABLE CURVE TYPE: F-J 12 PIN AUTO ID AND AN ISSUE OCCURRED OF FOREIGN MATTER INSIDE THE PACKAGING. IT WAS REPORTED THAT THE REPROCESSED CATHETER (CATHETER EZ STEER BI-DIRECTIONAL CS DEFECTABLE CURVE TYPE: F-J 12 PIN AUTO ID) WAS DIRTY UPON OPENING THE PACKAGE. IT HAD BLOOD ON IT WHEN IT WAS OPENED. THE CATHETER WAS REPLACED AND THAT RESOLVED THE ISSUE. THE PROCEDURE CONTINUED. THERE WAS NO PATIENT CONSEQUENCE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED. THE BLOOD WAS OBSERVED NEAR THE HANDLE. IT WAS INSIDE THE STERILE PACKAGE. IT WAS DESCRIBED AS DRIED BLOOD. THERE WAS NO PATIENT CONSEQUENCE AS IT WAS CAUGHT BEFORE IT WAS INTRODUCED INTO THE STERILE FIELD. THE EVENT WAS ASSESSED AS MDR REPORTABLE FOR FOREIGN MATTER INSIDE THE PACKAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16549968 ↗