WEBSTERRecalls & reported problems across all models
Biosense Webster Inc · 29 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 57
- Deaths reported
- 0
- Injuries reported
- 25
- Recalls
- 0
We found 29 models of WEBSTER by Biosense Webster Inc in the FDA's device registry (GUDID). Together they are named in 57 adverse event reports in the FDA's MAUDE database, received between Sep 28, 2017 and Jul 29, 2026 — classified as 25 injuries, 32 malfunctions.
The most frequently reported specific device problem is “Patient Device Interaction Problem” (14 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported WEBSTER problems
Device problems
- Patient Device Interaction Problem14
- Adverse Event Without Identified Device or Use Problem11
- Break8
- Material Protrusion/Extrusion5
- Material Twisted/Bent5
- Material Separation4
- Contamination /Decontamination Problem3
- Device Issue2
Patient problems
- No Clinical Signs, Symptoms or Conditions24
- Cardiac Tamponade18
- No Consequences Or Impact To Patient7
- Cardiac Arrest2
- Heart Block2
- No Code Available2
- Arrhythmia1
- Cardiac Perforation1
WEBSTER models
29 models, most reported first. Each model has its own page with its reports, recalls and device details.
- WEBSTER D728260RTCATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING8 reports
- WEBSTER F5ADP282RTCATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING5 reports
- WEBSTER D610DRP10RTCATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING4 reports
- WEBSTER D6DR005RTCATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING3 reports
- WEBSTER D708DR002RTCATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING3 reports
- WEBSTER F5QA005CTCATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING3 reports
- WEBSTER D6DR252RTCATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING2 reports
- WEBSTER F6QF005RTCATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING2 reports
- WEBSTER D610FR252RTCATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING2 reports
- WEBSTER F5QA252RTCATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING2 reports
- WEBSTER F5QF005CTCATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING2 reports
- WEBSTER F6ADP282RTCATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING2 reports
- WEBSTER F6QA005CTCATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING2 reports
- WEBSTER F6QA252RTCATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING2 reports
- WEBSTER 1085122RTCATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING1 report
- WEBSTER F6QA005RTCATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING1 report
- WEBSTER 1086259RTCATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING1 report
- WEBSTER D606DR002RTCATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING1 report
- WEBSTER D6DR010RTCATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING1 report
- WEBSTER D6DR252CTCATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING1 report
- WEBSTER D6FR252RTCATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING1 report
- WEBSTER D7DR252RTCATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING1 report
- WEBSTER F5QD005RTCATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING1 report
- WEBSTER F6QD005RTCATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING1 report
- WEBSTER F6QD010RTCATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING1 report
- WEBSTER F6QF002RTCATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING1 report
- WEBSTER F6QF005CTCATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING1 report
- WEBSTER F6QF252RTCATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING1 report
- WEBSTER D1085413CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING1 report
Recent WEBSTER adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryJul 29, 2026Patient Device Interaction Problem
It was reported that a patient underwent an ablation procedure with a WEBSTER Catheter and experienced a cardiac tamponade which required pericardiocentesis.After procedure, patient was alert and oriented during groin access closure, but just after, the patient dropped their blood pressure to 50/20 and became non-responsive. Doctor used an ultrasound machine and checked with a probe on the patient¿s chest for a pericardial effusion. The patient did have one, therefore, the doctor performed a pericardiocentesis on the patient and a total of 400cc came out. Patient was stabilized, woke up and blood pressure was 152/73 on no medications. Extended hospitalization was required as the patient spent the night in the intensive care unit. Patient fully recovered. Blood pressure stabilized and she became alert and orientated again. She just has pain in her chest where the drain is. Doctor believes Biosense quad catheter perforated the right ventricle.Multiple attempts have been made to obtain clarification to this complaint. However, no further information has been made available.
Patient problems: Cardiac Tamponade
MAUDE report 50077585 ↗InjuryDec 12, 2025Patient Device Interaction Problem; Patient Device Interaction Problem
DURING CARDIAC ABLATION PROCEDURE WITH A WEBSTER QUAD CATHETER, THE PATIENT EXPERIENCED VENTRICULAR FIBRILLATION (VF) TREATED WITH CHEST COMPRESSIONS AND DEFIBRILLATION ABOUT 5-6 TIMES. THE LAST KNOWN STATUS OF THE PATIENT WAS THAT THEIR BLOOD PRESSURE WAS NORMAL, THEY WERE IN SINUS RHYTHM, AND A STAT ECHO WAS ORDERED. IT WAS REPORTED THAT WHILE STEMMING THE VENTRICLE TO SEE THE SEVERITY OF THE PATIENT'S VT (VENTRICULAR TACHYCARDIA), IT STARTED IN VT AND DETERIORATED INTO VF. THE PATIENT¿S BLOOD PRESSURE PLUMMETED, AND THE MEDICAL TEAM HAD TO CALL A CODE. THE PATIENT WAS ALREADY INTUBATED WHEN THEY NOTICED THE DROP IN BLOOD PRESSURE. THEY NOTICED THIS DUE TO THE 12LEAD BEING ALL VF AND WAS CONFIRMED ON X-RAY AND WITH THE QUAD CATHETER THAT WAS IN THE RIGHT VENTRICLE. THE ONLY KNOWN MEDICAL INTERVENTION PROVIDED TO THE PATIENT WERE CHEST COMPRESSIONS AND DEFIBRILLATION ABOUT 5-6 TIMES. THE ONLY BWI IN USE AT THE TIME WAS A QUAD CATHETER (FIX 6F,4P,A,SD,5MM,10PN-DR,115), CARTO 3 SYSTEM, AND PATCHES ON THE PATIENT. NO GENERATOR WAS IN USE, AND THE CASE WAS ABORTED. THE INFORMATION RECEIVED INDICATED THAT THE INTERVENTION PROVIDED WAS ANESTHESIA PROTOCOL. THE OUTCOME OF THE ADVERSE EVE
Patient problems: Cardiac Arrest; Ventricular Fibrillation
MAUDE report 23796296 ↗MalfunctionMay 9, 2025Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A WEBSTER CATHETER AND THE TIP WAS FOUND BROKEN (ALMOST DETACHED). THERE WERE NO LIFTED NOR SHARP RINGS. THERE WAS RESISTANCE NOR DIFFICULTY DURING INSERTION OR REMOVAL OF THE CATHETER. THE DEVICE WAS NOT PRE-SHAPED. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21991338 ↗InjuryApr 21, 2025Patient Device Interaction Problem; Patient Device Interaction Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION AND A LEFT APPENDAGE OCCLUSION PROCEDURE WITH A WEBSTER¿ ELECTROPHYSIOLOGY CATHETER AND THE PATIENT EXPERIENCED CARDIAC TAMPONADE THAT REQUIRED PERICARDIOCENTESIS AND DRAIN PLACEMENT. EARLY DURING THE CASE, AFTER GOING TRANSSEPTAL, THE PATIENT ENDED UP DEVELOPING A PERICARDIAL EFFUSION. THE FIRST SIGN WAS THE DROP OF BLOOD PRESSURE WHICH THE PHYSICIAN CONFIRMED USING THE ICE (INTRACARDIAC ECHOCARDIOGRAPHY) NUVISION¿ ULTRASOUND CATHETER. THE PATIENT WAS IMMEDIATELY TAPPED AND A DRAIN WAS PUT IN PLACE BY THE ELECTROPHYSIOLOGIST. THE MEDICAL TEAM CONTINUED TO MONITOR THE PATIENT FOR ABOUT 30-45 MINUTES, AND SOME HEPARIN WAS ADMINISTERED TO ENSURE THE EFFUSION WOULD NOT TRIGGER. THE NUVISION¿ ULTRASOUND CATHETER WAS USED TO GUIDE THE WATCHMAN¿ PORTION OF THE CASE, SO THEY DID TAKE THE CATHETER ACROSS THE SEPTUM, AFTER GOING TRANSSEPTAL. THE EFFUSION FORMED AFTER THE CATHETER WAS BROUGHT BACK TO THE RIGHT SIDE, IN A PERIOD OF ABOUT TWO MINUTES AFTER. THE EFFUSION DID NOT COME BACK AND THE PHYSICIAN CONTINUED WITH THE CASE. THEY COMPLETED THE ABLATION AND FOLLOW UP WATCHMAN. THE CASE CONTINUED AND ENDED SUCCESSFULLY
Patient problems: Cardiac Tamponade
MAUDE report 21875418 ↗MalfunctionFeb 26, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT A PATIENT UNDERWENT A SUPRAVENTRICULAR TACHYCARDIA (SVT) ABLATION PROCEDURE WITH A WEBSTER¿ ELECTROPHYSIOLOGY CATHETER WITH AUTO ID AND OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY AND THE DEVICES GOT ENTANGLED DURING THE PROCEDURE. THE PHYSICIAN WAS ATTEMPTING TO REMOVE THE OPTRELL CATHETER FROM THE VIZIGO SHEATH WHEN THE WEBSTER QUAD--THAT WAS IN THE HEART--GOT ENSNARED IN THE OPTRELL CATHETER GRID. MEANWHILE, THE OPTRELL CATHETER WAS STUCK IN THE SHEATH AND PULLED THE WEBSTER QUAD INTO THE SHEATH WITH IT. THIS EVENT DID NOT CAUSE AN INJURY TO THE PATIENT BUT WAS MORE OF A "HOLD UP" OR DELAY IN THE PROCEDURE. THE PHYSICIAN WASN'T QUITE SURE WHAT TO DO SO THEY ENDED UP CUTTING THE WEBSTER QUAD CATHETER AT THE HANDLE AND PULLED IT OUT OF THE BODY. DUE TO THE MULTIPLE MORPHOLOGIES, THE PROCEDURE WAS ABORTED AFTER THE CATHETERS WERE REMOVED FROM THE BODY. NO MEDICAL INTERVENTION WAS PERFORMED. THE PATIENT WAS UNDER AESTHESIA FOR AN UNKNOWN AMOUNT OF TIME. NO TRANSSEPTAL PUNCTURE WAS PERFORMED PRIOR TO CASE CANCELLATION. THE PATIENT'S LAST KNOWN STATUS WAS STABLE. THIS REPORT IS FOR THE WEBSTER¿ ELECTROPHYSIOLOGY CATHETER WITH AUTO ID. A SEPARATE REPORT WILL B
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21472522 ↗InjuryOct 14, 2024Patient Device Interaction Problem; Patient Device Interaction Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL TACHYCARDIA ABLATION PROCEDURE WITH A WEBSTER AND THE PATIENT EXPERIENCED PERICARDIAL EFFUSION THAT REQUIRED PERICARDIOCENTESIS AND DRAIN PLACEMENT. IT WAS REPORTED THAT DURING AN ATRIAL TACHYCARDIA CASE, A PERICARDIAL EFFUSION WAS NOTICED. THE PHYSICIAN NOTICED WHEN GOING TRANSSEPTAL THAT THE INTRACARDIAC ECHOCARDIOGRAPHY (ICE) IMAGES DIDN¿T LOOK THE WAY THEY SHOULD. THIS CAUSED THEM TO NOTICE THE DROP IN BLOOD PRESSURE SO THEY CHECKED FOR ANY COMPLICATIONS. NO ABLATION HAD BEEN COMPLETED WHEN THE INJURY OCCURRED. THE PERICARDIAL EFFUSION WAS CONFIRMED BY ICE. THE MEDICAL INTERVENTION PROVIDED WAS A PERICARDIOCENTESIS. THE PATIENT FULLY RECOVERED, HOWEVER, REQUIRED EXTENDED HOSPITALIZATION (PATIENT HAD TO SPEND 2 NIGHTS IN THE HOSPITAL WAITING FOR THE DRAIN TO BE REMOVED AND WATCHING TO MAKE SURE SHE WAS COMPLETELY RECOVERED). THE PHYSICIAN BELIEVED THE RV WAS PERFORATED USING THE QUAD CATHETER DURING THE TRANSSEPTAL PUNCTURE BECAUSE THE EFFUSION WAS BIGGER ON THE RIGHT SIDE OF THE HEART.
Patient problems: Cardiac Tamponade
MAUDE report 20447496 ↗MalfunctionSep 9, 2024Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT A SUPRAVENTRICULAR TACHYCARDIA PROCEDURE WITH A WEBSTER AND THE TIP WAS DAMAGED/BROKEN ISSUE OCCURRED. DEVICE DAMAGED. IT WAS REPORTED THAT DURING THE PROCEDURE, THE TIP OF THE CATHETER WAS BROKEN (AS THE PHOTOS SHOW) WHEN IT WAS INSERTED INTO THE 6F SHEATH. A SECOND DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE EVENT REPORTED ON PATIENT. ADDITIONAL INFORMATION WAS RECEIVED ON 18-AUG-2024. THE TIP WAS DAMAGED/BROKEN. INTERNAL MECHANISM EXPOSED. THERE WAS A CRACK AT THE TIP. THERE WAS NO LIFTED OR DAMAGED ELECTRODES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20173900 ↗MalfunctionSep 6, 2024Contamination /Decontamination Problem; Communication or Transmission Problem; Contamination /Decontamination Problem; Communication or Transmission Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION PROCEDURE WITH A WEBSTER¿ ELECTROPHYSIOLOGY CATHETER AND THERE WAS FOREIGN MATTER IN THE CONNECTOR. IT WAS REPORTED THAT DURING THE OPERATION, IT WAS FOUND THAT THERE HAD BEEN FOREIGN MATTER IN THE CONNECTOR PIN HOLES OF THE DEVICE, WHICH MADE IT UNABLE TO CONNECT TO THE CABLE PROPERLY. THERE WAS NO ISSUE WITH MANEUVERING OR WITHDRAWING THE CHARACTER. THE CATHETER PEBAX WAS NOT DAMAGED. A SECOND DEVICE WAS USED TO COMPLETE THE OPERATION. THERE WAS NO ADVERSE EVENT REPORTED ON PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20160994 ↗MalfunctionAug 14, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIOVENTRICULAR NODAL REENTRANT TACHYCARDIA (AVNRT) PROCEDURE WITH A WEBSTER CATHETER. THERE WAS A HAIR PRESENT INSIDE OF THE STERILE PACKAGING OF THE WEBSTER CATHETER. THE WEBSTER CATHETER WAS REPLACED AND THE PROCEDURE CONTINUED. THERE WAS NO PATIENT CONSEQUENCE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED. THE ISSUE WAS NOTICED BEFORE USE AND THEREFORE, NOT USED ON THE PATIENT. IF THEY HAVE NOT ALREADY, THEY WILL SHIP BACK ALL THE MATERIALS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19982702 ↗MalfunctionAug 12, 2024Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT A PAROXYSMAL ATRIAL FIBRILLATION PROCEDURE WITH A WEBSTER CATHETER. DURING THE PROCEDURE, THE CATHETER WAS FOUND WITH A SCRATCH ON THE SHAFT (WITH NO EXPOSED WIRE). A SECOND DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE EVENT REPORTED ON PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19964296 ↗MalfunctionJul 2, 2024Material Separation; Manufacturing, Packaging or Shipping Problem; Material Separation; Manufacturing, Packaging or Shipping Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT A PAROXYSMAL ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A WEBSTER AND A HOLE WAS FOUND IN THE SHAFT OF THE DEVICE. THE DEVICE WAS DAMAGED. IT WAS REPORTED THAT BEFORE THE OPERATION, AFTER THE PACKAGE WAS OPENED, THE SHAFT OF THE CATHETER WAS FOUND WITH A HOLE (WITH NO EXPOSED WIRE). A SECOND DEVICE WAS USED TO COMPLETE THE OPERATION. THERE WAS NO ADVERSE EVENT REPORTED ON PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19662670 ↗MalfunctionSep 11, 2023Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT A SUPRAVENTRICULAR TACHYCARDIA (SVT) CARDIAC ABLATION PROCEDURE WITH A WEBSTER¿ ELECTROPHYSIOLOGY CATHETER AND DURING THE OPERATION, THE TIP OR SPLINES OF THE CATHETER WAS FOUND BENT (NO EXPOSED WIRES). A SECOND DEVICE WAS USED TO COMPLETE THE OPERATION. THERE WAS NO ADVERSE EVENT REPORTED ON PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17726512 ↗InjuryAug 14, 2023Patient Device Interaction Problem; Patient Device Interaction Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT IDVT (IDIOPATHIC VENTRICULAR TACHYCARDIA) ABLATION THAT INCLUDED WEBSTER¿ ELECTROPHYSIOLOGY CATHETER. THE PATIENT EXPERIENCED CARDIAC TAMPONADE THAT REQUIRED PERICARDIOCENTESIS. TIMING OF ADVERSE EVENT: DURING USE OF BWI PRODUCTS, DURING MAPPING PHASE DESCRIPTION OF HEALTH HAZARD: IT WAS REPORTED THAT THE PATIENT SUFFERED A PERICARDIAL EFFUSION. THERE WAS A WEBSTER QUAD IN THE RV APEX. THE PATIENT'S BLOOD PRESSURE DROPPED. THE MEDICAL TEAM WAS NOT ABLE TO VISUALIZE THE PERICARDIAL EFFUSION TO CONFIRM THE EFFUSION. A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) WAS PERFORMED AND A PERICARDIOCENTESIS WAS PERFORMED. AN UNKNOWN AMOUNT OF FLUID WAS REMOVED. THE MEDICAL TEAM DID NOT HAVE ANY ADDITIONAL INFORMATION ABOUT THE IMMEDIATE INTERVENTION AS THEY "STEPPED OUT OF THE ROOM". APPROXIMATELY HALF AN HOUR TO AN HOUR LATER, THEY PUT THE SOUNDSTAR CATHETER IN AND CONFIRMED THAT THERE WAS NO LONGER AN EFFUSION. THE DRAINAGE TUBE WAS LEFT IN PLACE, FOR THE REMAINDER OF THE PROCEDURE. THE PROCEDURE WAS CONTINUED AND COMPLETED SUCCESSFULLY. THE PHYSICIAN BELIEVED THAT WHEN PACING FROM THE QUAD ALONG WITH EPINEPHRINE IT MAY HAVE CAUSED THE RIGHT VENTRICLE (RV)
Patient problems: Cardiac Tamponade
MAUDE report 17538659 ↗MalfunctionJul 26, 2023Material Protrusion/Extrusion; Material Protrusion/Extrusion
IT WAS REPORTED THAT A PATIENT UNDERWENT A AFIB - PAROXYSMAL ABLATION PROCEDURE WITH A WEBSTER¿ ELECTROPHYSIOLOGY CATHETER, HOWEVER, PRIOR TO THE OPERATION, THE TIP OF THE CATHETER WAS FOUND DAMAGED (NO EXPOSED WIRES). A SECOND DEVICE WAS USED TO COMPLETE THE OPERATION. THERE WAS NO ADVERSE EVENT REPORTED ON PATIENT. DEVICE WAS NOT USED IN PATIENT. THE DAMAGED TIP IS MDR-REPORTABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17398974 ↗MalfunctionMar 29, 2023Manufacturing, Packaging or Shipping Problem; Material Protrusion/Extrusion; Manufacturing, Packaging or Shipping Problem; Material Protrusion/Extrusion
IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN ABLATION PROCEDURE. HOWEVER, THE WEBSTER CS CATHETER WAS DAMAGED PRE-OPERATIVELY: THE CATHETER HAD BEEN FOUND DAMAGED WHEN THE PACKAGE WAS OPENED. THE BOX AND PACKAGING WAS NOT DAMAGED. THE INTERNAL COMPONENTS WERE EXPOSED. THE DAMAGE DID NOT RESULT IN SHARP OR LIFTED RINGS. A LIKE DEVICE WAS USED TO COMPLETE THE OPERATION. THERE WAS NO ADVERSE EVENT REPORTED ON PATIENT. OUT OF BOX FAILURE IS NOT MDR-REPORTABLE. INTERNAL PARTS EXPOSED IS MDR-REPORTABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16634068 ↗
Other Biosense Webster Inc products
- THERMOCOOL SMARTTOUCH SF8 models · 6,238 reports · 1 recall
- VIZIGO3 models · 5,206 reports · 4 recalls
- QDOT MICRO7 models · 1,418 reports
- ThermoCool SmartTouch7 models · 1,163 reports
- PENTARAY NAV12 models · 842 reports · 4 recalls
- OCTARAY Mapping Catheter6 models · 407 reports
- CARTO VIZIGO2 models · 349 reports
- SOUNDSTAR6 models · 260 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page