Webster CS BD710DF282RTSRecalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10846835002416), received between Aug 20, 2019 and Sep 18, 2026 — classified as 6 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (5 reports).

1 other recall cover devices cleared under the same FDA submission (K101345); they may or may not involve this specific model.

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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2026Adverse Event Without Identified Device or Use Problem

  EZ Steer deca catheter failed related to PIN malfunction./Catheter removed and exchanged with Inquiry deca catheter. No Pt Harm.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50818203 ↗
• MalfunctionDec 29, 2025Tear, Rip or Hole in Device Packaging; Packaging Problem; Tear, Rip or Hole in Device Packaging; Packaging Problem

  IT WAS REPORTED THAT UPON RECEIPT OF THE NEW WEBSTER CS CATHETER PRODUCT, IT WAS NOTICED THAT THE PRODUCT PACKAGING WAS DAMAGED. THE CALLER REPORTED THAT THE PRODUCT BOX WAS OPENED AT THE TOP, AND THE BOX ITSELF APPEARS "SQUISHED AND TORN." THE CALLER REPORTED THAT UPON INSPECTION, IT WAS CONFIRMED THAT THERE IS A RIP IN THE STERILE POUCH SEAL OF THE WEBSTER CS CATHETER AS WELL. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23905728 ↗
• MalfunctionNov 26, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A WEBSTER CS AND BEFORE OPENING THE CATHETER FOR THE PROCEDURE, THERE WAS APPROXIMATELY 8MM LENGTH, WITH A DIAMETER OF A THREAD, INSIDE THE PLASTIC TRAY OF THE UNOPENED PACKAGE. THEY OPENED ANOTHER CATHETER AND THE CASE CONTINUED. NO ADVERSE PATIENT CONSEQUENCE WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23654226 ↗
• MalfunctionJun 23, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ATRIAL FIBRILLATION - PERSISTENT ABLATION PROCEDURE WITH A QDOT MICRO¿ CATHETER AND POST PROCEDURE THE BWI PRODUCT ANALYSIS LAB IDENTIFIED A HOLE ON THE PEBAX WITH INTERNAL PARTS EXPOSED AND ROCKER ARM DETACHED. DURING THE PROCEDURE, WHEN GOING ON ABLATION USING Q MODE, THE "HI" FORCE READING WAS DISPLAYED ON THE CARTO 3 SYSTEM. THE MEDICAL TEAM TRIED TO REZERO TWICE WITHOUT RESOLUTION. THE CABLE WAS REPLACED WITH NO RESOLUTION. WHEN THE CATHETER WAS REPLACED, THE ISSUE RESOLVED. THE PROCEDURE CONTINUED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22310566 ↗
• MalfunctionJun 23, 2025Signal Artifact/Noise; Signal Artifact/Noise

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ATRIAL FIBRILLATION - PAROXYSMAL ABLATION PROCEDURE WITH A WEBSTER® CS BI-DIRECTIONAL CATHETER AND POST PROCEDURE THE BWI PRODUCT ANALYSIS LAB REVEALED FOREIGN MATERIAL IN THE DOME AREA. DURING THE PROCEDURE, THERE WAS NOISE DISPLAYED ON THE DISTAL BIPOLAR SIGNALS FOR THE WEBSTER® CS BI-DIRECTIONAL CATHETER, ON THE CARTO¿ 3 AND RECORDING SYSTEM. THE CABLE WAS REPLACED WITHOUT RESOLUTION. THE WEBSTER® CS BI-DIRECTIONAL CATHETER WAS REPLACED AND THE ISSUE WAS RESOLVED. THE PROCEDURE CONTINUED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22310431 ↗
• MalfunctionAug 3, 2024Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A HALO AND WEBSTER CS AND THE DEVICES WERE ENTANGLED WITH EACH OTHER WITHIN THE PATIENT¿S BODY. DURING REDO PVI AND RIGHT SIDES FLUTTER ABLATION THE HALO CATHETER GOT TRAPPED AND ENTANGLED AROUND THE WEBSTER CS CATHETER. THE PHYSICIAN WAS UNABLE TO PULL OUT THE CATHETERS NOR WAS HE ABLE TO DETANGLE THEM. A JUGULAR APPROACH WITH A FISHING DEVICE WAS NEEDED TO EVACUATE BOTH CATHETERS FROM THE BODY. THE PATIENT LEFT OPERATING ROOM UNHARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19901552 ↗
• InjuryJun 4, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FLUTTER LEFT (L-AFL) ABLATION PROCEDURE WITH A WEBSTER ® CS CATHETER WITH EZ STEER¿ TECHNOLOGY AND AN OCTARAY, GALAXY, 48P, 3-3-3-3-3, F-CURVE. THE PATIENT EXPERIENCED CARDIAC TAMPONADE THAT REQUIRED PERICARDIOCENTESIS. IT WAS REPORTED THAT DURING A LEFT-SIDED ATRIAL FLUTTER CASE, A PERICARDIAL EFFUSION WAS NOTICED IN THE PATIENT. AFTER PLACING BI-DIRECTIONAL WEBSTER CS CATHETER IN THE CORONARY SINUS, AND GOING TRANSSEPTAL WITH THE OCTARAY CATHETER, IN THE PROCESS OF GOING TRANSSEPTAL, THE PATIENT'S RHYTHM CHANGED FROM A ¿RAPID¿ TACHYCARDIA RHYTHM TO A SLOWER A-TYPICAL RHYTHM. THE PATIENT'S BLOOD PRESSURE AND HEART RATE DROPPED. AT THIS POINT, THE BI-DIRECTIONAL WEBSTER CS CATHETER "FELL OUT" OF THE CORONARY SINUS. THE PERICARDIAL EFFUSION WAS DISCOVERED AND CONFIRMED ON INTRACARDIAC ECHOCARDIOGRAPHY (ICE), POSTERIOR BEHIND THE LEFT VENTRICLE. THE PATIENT WAS THEN ADMINISTERED BLOOD PRESSURE MEDICATION, AND A BLOOD TRANSFUSION WAS PERFORMED (ABOUT 600CC OF BLOOD WAS TRANSFUSED TO THE PATIENT). THE PATIENT WAS IN STABLE CONDITION AND WAS ADMITTED TO THE INTENSIVE CARE UNIT (ICU). THE QDOT CATHETER WAS NEVER INSERTED INTO THE BODY. T

  Patient problems: Cardiac Tamponade

  MAUDE report 19463732 ↗
• InjuryDec 8, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WHICH INCLUDED THE USE OF WEBSTER® CS EZ STEER CATHETER EXPERIENCED CARDIAC TAMPONADE AND REQUIRED SURGICAL INTERVENTION. IT WAS REPORTED THE MEDICAL TEAM PLACED THE CS (CORONARY SINUS) CATHETER, AND AFTER PLACING IT THEY DID THE PUNCTURE FROM THE RIGHT TO THE LEFT. THEY THEN USED 2 SHEATHS IN WHICH THEY PLACED THE PENTARAY AND QDOT CATHETERS, BUT THEY THINK THE "FIRST PUNCTURE ON THE LEFT SIDE HAS BEEN TAMPONADE OF THE WIRE FROM A BOX." THEY THEN MADE A MAP OF THE LEFT ATRIUM BECAUSE THE PATIENT WAS ON AT (ATRIAL TACHYCARDIA). BECAUSE THE BLOOD PRESSURE WAS VERY LOW, THEY LOOKED AT THE ECHO (ECHOCARDIOGRAM) WITH THE TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) AND SAW THE TAMPONADE. BECAUSE THE BLOOD PRESSURE WAS TOO LOW THEY STARTED TO REANIMATE THE PATIENT. ALL THE PRODUCT WERE EXTRACTED FROM THE HEART, AND DID A EP (ELECTROPHYSIOLOGY) CARDIO PUNCTURE IN THE FORM OF A PERICARDIOCENTESIS. THE MEDICAL TEAM EXTRACTED THE FLUID OF THE HEART FROM THE OUTSIDE, AND BECAUSE THE PATIENT WAS STILL BLEEDING FROM THE OUTSIDE, THE PATIENT HAS BEEN GOING TO THE OPERATING ROOM. THIS ADVERSE EVENT IS BEING CAPTURED ON THE WEBSTER® CS EZ S

  Patient problems: Cardiac Tamponade

  MAUDE report 18292822 ↗
• InjuryNov 1, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE USING WEBSTER ® CS CATHETER WITH EZ STEER¿ TECHNOLOGY. THE PATIENT EXPERIENCED PERICARDIAL EFFUSION THAT RESULTED IN PROCEDURE CANCELLATION. DURING THE PROCEDURE, THE MEDICAL TEAM NOTED A PERICARDIAL EFFUSION DURING A STANDARD CHECK. THE PERICARDIAL EFFUSION WAS CONFIRMED BY ICE (INTRACARDIAC ECHOCARDIOGRAPHY). THE MEDICAL INTERVENTION INCLUDED PROVIDING PROTAMINE TO THE PATIENT AND THE PATIENT CONTINUED TO BE MONITORED. THE PROCEDURE WAS CANCELED. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. THE CAUSE OF THE PERICARDIAL EFFUSION COULD NOT BE CONFIRMED BUT THEY WERE HAVING TROUBLE INSERTING THE CS CATHETER EARLIER IN THE PROCEDURE. THE CATHETER HAD AN ISSUE FALLING OUT AND ¿KEEPING IT IN¿. THE PHYSICIAN COULD NOT CONFIRM IF THIS CAUSED THE PERICARDIAL EFFUSION OR IF IT WAS CAUSED BY SOMETHING ELSE PRIOR TO THE PROCEDURE. PHYSICIAN'S OPINION ON THE CAUSE OF THE ADVERSE EVENT WAS THE PROCEDURE. THE PATIENT HAD FULLY RECOVERED. PATIENT DID NOT REQUIRE EXTENDED HOSPITALIZATION. NO TRANSSEPTAL PUNCTURE WAS PERFORMED. NO ABLATION WAS PERFORMED PRIOR TO NOTING PERICARDIAL EFFUSION. NO EVIDENCE OF STEAM POP. THIS

  Patient problems: Pericardial Effusion

  MAUDE report 18052155 ↗
• MalfunctionDec 8, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT A PATIENT WAS GOING TO UNDERGO AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A WEBSTER ® CS CATHETER WITH EZ STEER¿ TECHNOLOGY AND A FOREIGN MATERIAL WAS FOUND IN THE CS CATHETER STERILE PACKAGING. IT WAS REPORTED THAT INSIDE THE STERILE CS CATHETER PACKAGING, THERE WAS A LITTLE PIECE OF FUZZ IN IT. THE FOREIGN MATERIAL APPEARED TO BE A SMALL BLACK PIECE OF FUZZ BUT THE PACKAGE WAS NOT OPENED AFTER NOTICING THIS. THE CATHETER WAS NOT USED ON THE PATIENT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. THE FOREIGN MATERIAL INSIDE THE PACKAGING (OUTSIDE OF SPEC) WAS ASSESSED AS MDR REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12961572 ↗
• InjurySep 9, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD-MALE PATIENT UNDERWENT A PAROXYSMAL ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A WEBSTER ® CS CATHETER WITH EZ STEER¿ TECHNOLOGY AND THE PATIENT SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS, SURGICAL INTERVENTION AND PROLONGED HOSPITALIZATION. DURING AN EP STUDY USING CARTO SOUND; DURING USE OF BIOSENSE WEBSTER PRODUCTS, THE PATIENT SUFFERED A PERICARDIAL EFFUSION. IT WAS DISCOVERED WHEN THE ANESTHESIOLOGIST STATED THAT THE PATIENT WAS NOT PERFUSING. THE SOUNDSTAR INTRACARDIAC ECHO CATHETER WAS USED TO VISUALIZE AND DIAGNOSE THE EFFUSION. A PERICARDIOCENTESIS WAS PERFORMED BUT WAS INSUFFICIENT TO STABILIZE THE PATIENT. THE PATIENT WAS SENT TO THE OPERATING ROOM (OR) FOR SURGICAL INTERVENTION. THE PATIENT'S STATUS WAS UNKNOWN AT THE TIME OF THE CALL. THE PHYSICIAN DID NOT INDICATE THAT BWI PRODUCTS CONTRIBUTED TO THE PATIENT EVENT. THE PHYSICIAN OPINION ON THE CAUSE OF THE ADVERSE EVENT WAS THAT THE NON-BWI RIGHT VENTRICULAR CATHETER LIKELY CAUSED THE ISSUE AS THE RV CATHETER PERFORATED THE RV. THE PATIENT¿S OUTCOME OF THE ADVERSE EVENT WAS REPORTED AS IMPROVED. THE PATIENT REQUIRED EXTENDED HOSPITALIZATION BECAUSE OF THE ADV

  Patient problems: Cardiac Tamponade

  MAUDE report 12449628 ↗
• InjuryDec 23, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CRYO ABLATION PROCEDURE FOR ATRIAL FIBRILLATION (AFIB) AND SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS AND SURGICAL INTERVENTION. DURING THE PROCEDURE, A WEBSTER ® CS CATHETER WITH EZ STEER¿ TECHNOLOGY WAS PLACED IN THE CORONARY SINUS (CS) AND WAS NOTED TO BE VERTICAL; HOWEVER, GOOD ELECTRICAL SIGNALS WERE OBSERVED. PROCEDURE WAS COMPLETED, AND ALL CATHETERS WERE REMOVED FROM THE PATIENT¿S BODY. POST-PROCEDURE, THE PATIENT¿S BLOOD PRESSURE BECAME UNSTABLE, AND THE PATIENT DID NOT FEEL WELL. ECHOCARDIOGRAPHY SHOWED PERICARDIAL EFFUSION. PERICARDIOCENTESIS WAS PERFORMED TO DRAIN THE PERICARDIAL SPACE; HOWEVER, THE EFFUSION DID NOT STOP. THE PATIENT WAS MOVED TO THE OPERATION ROOM AND A STERNOTOMY WAS PERFORMED TO CHECK FOR PERFORATIONS OF THE LEFT ATRIUM TO DETERMINE THE TAMPONADE SITE. NO VISUAL PERFORATIONS WERE NOTED; HOWEVER, THE CAVITY CONTINUED TO FILL. DISCUSSION WITH ELECTROPHYSIOLOGIST WHO ASKED SURGEONS TO PHYSICALLY LIFT HEART OUT TO LOOK ANTERIOR. FAT PATCH OVER AREA LIFTED, AND PERFORATION OF THE CS FOUND, THE DISTAL CS CATHETER HAD PERFORATED CS DURING INITIAL INSERTION. THE PERFORATION WAS SURGICALLY REPAIRED. PATI

  Patient problems: Cardiac Tamponade

  MAUDE report 11062353 ↗
• MalfunctionJan 7, 2020Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LEFT ATRIAL TACHYCARDIA ABLATION PROCEDURE WITH A WEBSTER ® CS CATHETER WITH EZ STEER¿ TECHNOLOGY AND AN ISSUE OF STERILITY BEING COMPROMISED OCCURRED. IT WAS REPORTED THAT THE PLASTIC COVER WAS MISSING IN THE PROTECTION SUPPORT UPON OPENING OF THE BOX. THE BLISTER WAS OPENED, SO THE PRODUCT WAS NOT IN PROTECTION SUPPORT AND WAS UNSTERILIZED. THERE WAS NO REPORT OF PATIENT CONSEQUENCE. THIS ISSUE OF PRODUCT STERILIZATION BEING COMPROMISED HAS BEEN ASSESSED AS AN MDR REPORTABLE MALFUNCTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9560650 ↗
• InjuryDec 16, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ISCHEMIC VENTRICULAR TACHYCARDIA ABLATION PROCEDURE WITH A WEBSTER ® CS CATHETER WITH EZ STEER¿ TECHNOLOGY AND SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. DURING THE PROCEDURE THE PATIENT HAD A CARDIAC TAMPONADE. PERICARDIOCENTESIS WAS PERFORMED AND 900 CCS OF FLUID WERE REMOVED FROM THE PERICARDIAL SPACE. THE PATIENT WAS STABILIZED AND TRANSFERRED TO THE CORONARY CARE UNIT FOR OBSERVATION. 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 9473150 ↗
• MalfunctionDec 11, 2019Coagulation in Device or Device Ingredient; Coagulation in Device or Device Ingredient

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABLATION PROCEDURE FOR ATRIAL FIBRILLATION WITH A WEBSTER ® CS CATHETER WITH EZ STEER¿ TECHNOLOGY (CS) CATHETER AND A THROMBUS ISSUE OCCURRED. THE PHYSICIAN NOTICED VIA INTRA-CARDIAC ULTRASOUND THAT A CLOT HAD FORMED ON THE PROXIMAL ELECTRODES ON THE CS CATHETER. WHEN THE CATHETER WAS REMOVED, PROXIMAL ELECTRODES DEFORMITY WAS ALSO NOTICED. THE PROCEDURE WAS THEN CANCELLED. NO PATIENT INJURY WAS REPORTED. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL DETAILS. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE. THE OBSERVED THROMBUS HAS BEEN ASSESSED AS AN MDR REPORTABLE MALFUNCTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9454676 ↗
• MalfunctionAug 20, 2019Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABLATION PROCEDURE WITH A WEBSTER ® CS CATHETER WITH EZ STEER¿ THECHNOLOGY, AND AN OPEN POUCH SEAL ISSUE OCCURRED. WHILE TAKING OUT THE CATHETER FROM THE BOX, IT WAS NOTICED THAT THE TOP OF THE PACKAGING WAS NOT SEALED. THE BOX WAS FINE. HOWEVER, THE INNER PACKAGING NOT SEALED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. THE OPEN POUCH SEAL ISSUE HAS BEEN ASSESSED AS AN MDR REPORTABLE MALFUNCTION AS DEVICE STERILITY WAS COMPROMISED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8913511 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K101345. One submission often covers many models, so check the product and lot details in each record.

• Z-1647-2012 · Dec 15, 2007 · Terminated
  EZ STEER Catheter D-1267-04-S / 8mm Non-Navigation Bi-Directional Catheter Cardiovascular catheter for use in electrophysiological diagnosis and ablation.