SMARTABLATE SAT001Recalls & reported problems

Summary

The FDA's MAUDE database contains 185 adverse event reports that list this exact device (DI 10846835009743), received between Aug 3, 2016 and Sep 30, 2026 — classified as 2 injuries, 183 malfunctions.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (77 reports).

3 other recalls cover devices cleared under the same FDA submission (P990071); 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 25 most recent of 185 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Obstruction of Flow

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50955188 ↗
• MalfunctionSep 30, 2026Contamination /Decontamination Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50941466 ↗
• MalfunctionSep 30, 2026Contamination /Decontamination Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50941445 ↗
• MalfunctionSep 26, 2026Contamination /Decontamination Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50906554 ↗
• MalfunctionSep 12, 2026Material Integrity Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50746583 ↗
• MalfunctionAug 27, 2026Contamination /Decontamination Problem

  It was reported that a patient underwent an Atrial Fibrillation (AFib) ablation procedure with a SMARTABLATE and debris came out of the irrigation tubing. It was reported that while priming the tubing, debris came out of the SMARTABLATE tubing when they were flushing and prepping the tubing. The tubing was connected to a bag of heparinized saline and the pump. The material was observed in a sterile cup after flushing the tubing. When the tubing was replaced with the same lot, the issue resolved. Device was not used on a patient.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50487482 ↗
• MalfunctionAug 11, 2026Contamination /Decontamination Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50216138 ↗
• MalfunctionAug 11, 2026Contamination /Decontamination Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50216129 ↗
• MalfunctionAug 11, 2026Contamination /Decontamination Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50216105 ↗
• MalfunctionApr 30, 2026Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE AND THE MEDICAL TEAM NOTED LEAKAGE FROM THE ROTATING PART ON THE PUMP WAS OBSERVED. WHEN THE TUBING SET WAS REMOVED FROM THE PUMP, A HOLE ON THE TUBE WAS FOUND. THE ISSUE WAS NOTED DURING ABLATION CATHETER USAGE. THE TUBING WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITHOUT PATIENT'S CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25049715 ↗
• MalfunctionApr 30, 2026Contamination /Decontamination Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PREMATURE VENTRICULAR CONTRACTION (PVC) ABLATION PROCEDURE WITH A SMARTABLATE TUBING AND FOREIGN MATERIAL WAS FOUND IN THE DRIP CHAMBER OF THE PUMP TUBING. IMMEDIATELY AFTER THE START OF PRIMING, A FOREIGN MATERIAL WAS FOUND IN THE DRIP CHAMBER OF THE PUMP TUBING. THE PARTICLE WAS WHITE, EXTREMELY SMALL FINE PARTICLE THAT WAS SEEN LOOSE (WITH MOVEMENT). THE ISSUE OCCURRED DURING PRIMING, BEFORE USED ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25049330 ↗
• MalfunctionApr 8, 2026Obstruction of Flow

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH SMART ABLATE IRRIGATION TUBE SET. WHEN ATTEMPTING TO FLUSH THE SMART ABLATE IRRIGATION TUBE SET FROM THE NGEN¿ MONITOR, IT WAS NOTICED THAT THERE WAS NO HIGH OR LOW FLOW OPTION DISPLAYED. THE SMARTABLATE IRRIGATION TUBE SET WAS FLUSHED WITHOUT RESOLUTION. THE SMARTABLATE IRRIGATION TUBE SET WAS REPLACED AND THE ISSUE WAS RESOLVED. THE PROCEDURE CONTINUED WITH NO FURTHER ISSUES. THERE WAS NO PATIENT CONSEQUENCE REPORTED. ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION OF THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24818666 ↗
• MalfunctionJan 9, 2026Contamination /Decontamination Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A SMARTABLATE AND WHEN THE TUBING SET WAS CONNECTED TO THE SALINE SOLUTION BAG, DIRT-LIKE POWDER WAS FOUND IN THE TUBE. THE DIRT-LIKE POWDER SEEMED TO BE FLUSHED; HOWEVER, THE TUBING SET WAS REPLACED WITH A NEW ONE DUE TO SANITARY REASONS. THE PROCEDURE WAS COMPLETED WITHOUT ADVERSE PATIENT CONSEQUENCE. ADDITIONAL INFORMATION INDICATED THAT THE MATERIAL OBSERVED WAS INSIDE THE TUBING. IT WAS LOOSE (WITH MOVEMENT) AND NO OCCLUSION WAS REPORTED. THE TUBING WAS NEVER USED ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24017029 ↗
• MalfunctionJan 7, 2026Contamination /Decontamination Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A SMARTABLATE AND THE TUBE APPEARED CLOUDY. AFTER OPENING, THE INSIDE OF THE TUBE APPEARED CLOUDY, AND WHEN PRESSED WITH A FINGER, IT SEEMED TO PEEL OFF. CONSIDERING THE RISK OF FOREIGN MATERIAL ENTERING THE PATIENT'S BODY, A NEW TUBING SET WITH THE SAME LOT NUMBER WAS TAKEN OUT, AND A SIMILAR APPEARANCE WAS CONFIRMED. WHEN THE THIRD TUBING SET WITH A DIFFERENT LOT NUMBER WAS USED, IT WAS TRANSPARENT AND DID NOT HAVE ANY ISSUES. SO, THE THIRD TUBING SET WAS USED. THE PROCEDURE WAS COMPLETED WITHOUT ADVERSE PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23987086 ↗
• MalfunctionJan 7, 2026Contamination /Decontamination Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A SMARTABLATE AND THE TUBE APPEARED CLOUDY. AFTER OPENING, THE INSIDE OF THE TUBE APPEARED CLOUDY, AND WHEN PRESSED WITH A FINGER, IT SEEMED TO PEEL OFF. CONSIDERING THE RISK OF FOREIGN MATERIAL ENTERING THE PATIENT'S BODY, A NEW TUBING SET WITH THE SAME LOT NUMBER WAS TAKEN OUT, AND A SIMILAR APPEARANCE WAS CONFIRMED. WHEN THE THIRD TUBING SET WITH A DIFFERENT LOT NUMBER WAS USED, IT WAS TRANSPARENT AND DID NOT HAVE ANY ISSUES. SO, THE THIRD TUBING SET WAS USED. THE PROCEDURE WAS COMPLETED WITHOUT ADVERSE PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23987085 ↗
• MalfunctionDec 18, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH A SMARTABLATE IRRIGATION TUBING SET. AN UNKNOWN FOREIGN OBJECT WAS WITHIN THE STERILE PACKAGING OF THE SMARTABLATE IRRIGATION TUBING SET. WHEN THEY OPENED THE IRRIGATION TUBING, A SMALL, BLUE, LATEX PLASTIC PIECE WAS SEEN IN THE PACKAGE. THE STAFF DISCARDED THE PLASTIC PIECE AND THE TUBING. THEY OPENED A NEW SET OF IRRIGATION TUBING AND THE ISSUE WAS RESOLVED. THE PROCEDURE CONTINUED. NO PATIENT CONSEQUENCE WAS REPORTED. ADDITIONAL INFORMATION WAS RECEIVED. THE ISSUE WAS NOTED BEFORE USE. THE FOREIGN MATERIAL WAS DESCRIBED AS A BLUE, LATEX, FLIMSY MATERIAL ABOUT 1-2CM LARGE. MATERIAL WAS LOOSE IN PACKAGING. IT WAS CONFIRMED THAT THE PRODUCT WAS DISCARDED, NOT USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23846816 ↗
• MalfunctionDec 13, 2025Material Integrity Problem; Protective Measures Problem; Material Integrity Problem; Protective Measures Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH A SMARTABLATE IRRIGATION TUBING SET AND OBSERVED A CRACK IN THE TUBE. DURING THE BUBBLE ERROR ON THE SMARTABLATE PUMP, RESET THE TUBE AND PERFORMED A FLUSH, IT WAS REVEALED THAT THERE WAS A LEAK OF THE IRRIGATION FLUID (CE STAFF WAS PERFORMING THE SETUP AND RELATED TASKS). SUBSEQUENTLY, A CRACK WAS CONFIRMED IN THE TUBE. TIMING WAS APPROXIMATELY 1 HOUR AND 30 MINUTES AFTER STARTED TO USE, DURING LOW FLOW IRRIGATION. THE ISSUE WAS RESOLVED BY REPLACING THE TUBING SET WITH ANOTHER NEW ONE. THE PROCEDURE WAS COMPLETED WITHOUT PATIENT'S CONSEQUENCE. THE BUBBLE ERROR ISSUE WAS ASSESSED AS NON MDR REPORTABLE. THE CRACK IN THE TUBE WAS ASSESSED AS A MDR REPORTABLE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23797200 ↗
• MalfunctionDec 5, 2025Contamination /Decontamination Problem; Air/Gas in Device; Contamination /Decontamination Problem; Air/Gas in Device

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE AND ¿WHITE LIKE FLUID IN TUBBING SET¿ AND BUBBLES WERE NOTED ON THE SMARTABLATE IRRIGATION TUBE SET. NO ADVERSE PATIENT CONSEQUENCE WAS REPORTED. THE BUBBLES IN TUBING IS NOT CONSIDERED MDR REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23724301 ↗
• MalfunctionAug 5, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VENTRICULAR TACHYCARDIA ABLATION PROCEDURE WITH A SMARTABLATE WHICH HAS LOOSE FOREIGN MATERIAL. IT WAS INITIALLY REPORTED BY THE CUSTOMER THAT BEFORE USE, A FOREIGN OBJECT WAS FOUND INSIDE THE TUBING. BUBBLES WERE NOT DETECTED. THE PROCEDURE WAS COMPLETED WITHOUT PATIENT'S CONSEQUENCE. THE CUSTOMER'S REPORTED FOREIGN OBJECT FOUND BEFORE USE IS NOT CONSIDERED TO BE MDR REPORTABLE SINCE THE POTENTIAL RISK THAT IT COULD CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR DEATH TO THE OPERATOR OR PATIENT IS REMOTE. ON 28-JUL-2025, ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE FOREIGN MATERIAL WAS LOOSE FLOATING INSIDE THE DRIP CHAMBER OF THE TUBING. THE FOREIGN MATERIAL WAS DESCRIBED AS WHITISH IN COLOR, APPROXIMATELY 1MM TO 2MM, SHAPED ¿SPHERICAL¿ FLOATING PARTICLE. SINCE THE ADDITIONAL INFORMATION RECEIVED INDICATES THE FOREIGN MATERIAL WAS LOOSE AND FLOATING WITHING THE CHAMBER OF THE TUBING, THE EVENT HAS REASSESSED AS AN MDR REPORTABLE MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22723519 ↗
• MalfunctionJul 22, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A SMARTABLATE AND AN IRRIGATION ISSUE OCCURRING DURING USE ON THE PATIENT. IT WAS INITIALLY REPORTED BY THE CUSTOMER THAT DURING THE OPERATION, THERE WAS AN INTERMITTENT OR LOW IRRIGATION ON THE DEVICE BUT NOT COMPLETE OCCLUSION. A SECOND DEVICE WAS USED TO COMPLETE THE OPERATION. THERE WAS NO ADVERSE EVENT REPORTED ON THE PATIENT. THE CUSTOMER'S REPORTED INTERMITTENT OR LOW IRRIGATION ISSUE IS NOT CONSIDERED TO BE MDR REPORTABLE SINCE THE POTENTIAL RISK THAT IT COULD CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR DEATH TO THE OPERATOR OR PATIENT IS REMOTE. ON 2-JUL-2025, ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE SUSPECTED DEVICE OF THE REPORTED FLOW/IRRIGATION ISSUE WAS THE TUBING. THE ISSUE WAS NOT NOTICED BEFORE USE ON THE PATIENT, IT WAS NOTICED DURING USE. THE PUMP SHOWED A BUBBLE ERROR. THERE WAS NO ISSUES WITH FLOW RATE CHANGE AT THE START OF ABLATION AND THERE WAS NO PHYSICAL DAMAGE TO THE DEVICE. THE CORRECT CATHETER SETTINGS WERE SELECTED ON THE GENERATOR. BASED ON THE NEW INFORMATION WHICH REPORTED THE IRRIGATION ISSUE OCCURRED DURING USE ON THE PATIENT, THE EVENT WAS REAS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22564082 ↗
• MalfunctionJul 14, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A SMARTABLATE AND DURING FLUSHING, BEFORE INSERTING INTO THE PATIENT¿S BODY, A WHITE POWDERY SUBSTANCE WAS MIXED IN. EVEN AFTER FLUSHING SEVERAL TIMES, THE ISSUE WAS NOT IMPROVED. IT WAS RESOLVED BY REPLACING THE TUBING SET WITH A NEW ONE. THE PROCEDURE WAS COMPLETED AND THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22502409 ↗
• MalfunctionJun 30, 2025Obstruction of Flow; Adverse Event Without Identified Device or Use Problem; Obstruction of Flow; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PREMATURE VENTRICULAR CONTRACTION CARDIAC ABLATION PROCEDURE WITH A QDOT MICRO CATHETER AND A SMARTABLATE IRRIGATION TUBING SET. JUST BEFORE ABLATION, THE QDOT MICRO CATHETER AND THE SMARTABLATE IRRIGATION TUBING SET COULD NOT PERFORM FLUSHING. RECONNECTED AND PERFORMED FLUSHING, BUT COULD NOT. THE CATHETER WAS REPLACED WITH AN ABLATION CATHETER FROM ANOTHER COMPANY. THE PROCEDURE WAS CONTINUED AND COMPLETED WITHOUT PATIENT CONSEQUENCE. THIS IRRIGATION ISSUE WAS ASSESSED AS MDR REPORTABLE UNDER BOTH THE QDOT MICRO CATHETER AND THE SMARTABLATE IRRIGATION TUBING SET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22353031 ↗
• MalfunctionJun 13, 2025Obstruction of Flow; Material Integrity Problem; Obstruction of Flow; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A SMARTABLATE AND DURING THE PROCEDURE, THERE WAS AN ISSUE WITH THE SMARTABLATE IRRIGATION TUBING SET. THE POWER ON THE CARTO 3 SYSTEM WAS TITRATING DOWN LOW AND THE HEAT MAP LOOKED DEFUSED AND RED. THE CATHETER WAS REMOVED FROM THE BODY AND THE CATHETER TIP LOOKED FINE. THEY WERE UNABLE TO FLUSH THE CATHETER. THE REPORTER STATED THE TUBING STOP COCK KNOB WAS LOOSE AND LOOKED LIKE IT WAS PUSHED TO THE SIDE. WHAT USED TO BE A YELLOW TUBING TO THE TUBING STOP COCK IS NOW WHITE IN COLOR. THEY OPENED THE STOP COCK AND WERE ABLE TO FLUSH THE CATHETER. THE PROCEDURE CONTINUED. NO ADVERSE PATIENT CONSEQUENCE WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22205972 ↗
• MalfunctionJun 10, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION AND DURING THE PROCEDURE, THE IRRIGATION SOLUTION WAS NOT DROPPING TO THE IRRIGATION TUBING. THEY CHANGED THE IRRIGATION BAG AND THE TUBING, AND THE ISSUE WAS RESOLVED. NO ADVERSE PATIENT CONSEQUENCE WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22181562 ↗
• MalfunctionJun 2, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A SMARTABLATE IRRIGATION TUBE SET AND THE PACKAGING WAS OPEN. INITIALLY IT WAS REPORTED THAT THERE WAS A CONTAMINATED ITEM, BLOCKED PACKAGING. NO DAMAGE WAS CAUSED TO THE PATIENT. NO PATIENT CONSEQUENCE. ADDITIONAL INFORMATION WAS REQUESTED AND A RESPONSE WAS RECEIVED WHICH CLARIFIED IT WAS NOT FOREIGN MATERIAL. IT WAS JUST OPENED PACKAGING. THE TOP CORNER OF THE PACKAGING WAS OPEN. SINCE THE PACKAGING WAS OPEN, THEY CONSIDERED THE MATERIAL CONTAMINATED AND COULD NOT BE USED ON THE PATIENT. CALLER DOES NOT HAVE ANY IMAGES. THE ITEM WAS IDENTIFIED BY THE HOSPITAL. MATERIAL DISCARDED ACCORDING TO HOSPITAL PROTOCOL. MATERIAL WAS NOT USED ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22129215 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P990071. One submission often covers many models, so check the product and lot details in each record.

• Z-0058-2018 · Sep 6, 2017 · Terminated
  THERMOCOOL SF NAV Catheters Model Numbers - BNI35FJCT, BNI35DFCT, D-131503-S, D-131504-S
• Z-3178-2011 · Jul 7, 2011 · Terminated
  STOCKERT 70 Radio Frequency Generator, Catalog Number 57001 Indicated for use with a Biosense Webster, Inc. diagnostic/ablation deflectable tip catheter to deliver radio frequenc
• Z-1328-04 · Jul 16, 2004 · Terminated
  Stockert 70 Radio Frequency Ablation Generator