CelsiusRecalls & reported problems across all models

We found 14 models of Celsius by Biosense Webster Inc in the FDA's device registry (GUDID). Together they are named in 25 adverse event reports in the FDA's MAUDE database, received between Jun 16, 2017 and Aug 15, 2024 — classified as 2 injuries, 23 malfunctions.

The most frequently reported specific device problem is “Break” (8 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

Most reported Celsius problems

Celsius models

14 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Celsius D7TCDL252RT

  Cardiac ablation percutaneous catheter
  4 reports
• Celsius D7TCFL252RT

  Cardiac ablation percutaneous catheter
  3 reports
• Celsius D7BTCDL252RT

  CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
  3 reports
• Celsius D7TDL252RT

  Cardiac ablation percutaneous catheter
  2 reports
• Celsius D7TFL252RT

  Cardiac ablation percutaneous catheter
  2 reports
• Celsius D7BTCFL252RT

  CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
  2 reports
• Celsius D7TCL252RT

  Cardiac ablation percutaneous catheter
  2 reports
• Celsius D7TCBL252RT

  Cardiac ablation percutaneous catheter
  1 report
• Celsius D6TCAL252RT

  Cardiac ablation percutaneous catheter
  1 report
• Celsius D6TCBL252RT

  Cardiac ablation percutaneous catheter
  1 report
• Celsius D7TBL252RT

  Cardiac ablation percutaneous catheter
  1 report
• Celsius D7TCEL252RT

  Cardiac ablation percutaneous catheter
  1 report
• Celsius D7TEL252RT

  Cardiac ablation percutaneous catheter
  1 report
• Celsius D8BTDL252RT

  CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
  1 report

Recent Celsius adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionAug 15, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABLATION PROCEDURE WITH A CELSIUS CATHETER AND A PIECE OF MELTED MATERIAL WAS ON THE CATHETER TIP. THE PHYSICIAN RETRACTED THE CATHETER FROM THE PATIENT¿S BODY AND NOTICED A PIECE OF MELTED MATERIAL ON THE CATHETER TIP. NO CONSEQUENCE FOR THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED ON 25-JUL-2024. THE DETAILS ON THE FOREIGN MATERIAL IS THAT IT IS PINK, 3MM SIZE, AND ELONGATED SHAPE. THE MATERIAL WAS LOOSE. THE DEVICE WAS USED ON THE PATIENT. RESPONDED YES TO CONFIRMATION IF IT WAS CHAR/CLOT ON THE TIP. ADDITIONAL CLARIFICATION WAS RECEIVED ON 08-AUG-2024 RESPONDING THAT THE REPORTER DOES NOT KNOW IF THE FOREIGN MATERIAL WAS ACTUALLY BIOLOGICAL MATERIAL AND DOES NOT KNOW IF IT IS CHAR. THE ISSUE WAS ASSESSED AS MDR REPORTABLE FOR FOREIGN MATERIAL ON THE USABLE LENGTH OF THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19997216 ↗
• MalfunctionApr 30, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A CELSIUS¿ ELECTROPHYSIOLOGY CATHETER AND THE MEDICAL TEAM DISCOVERED A BREAK IN THE TIP BEFORE IT WAS USED ON THE PATIENT. UPON ARRIVAL INTO LAB 1, THE FELLOW WHO WAS WORKING IN LAB 2 BROUGHT TO THE MEDICAL TEAM'S ATTENTION THAT THE CELSIUS 4MM CATHETER'S TIP WAS BROKEN. THERE WERE NO EXPOSED WIRES OR INTERNAL COMPONENTS, BUT THE TIP WAS CONFIRMED AS "BROKEN". A NEW CATHETER WAS USED FOR THE PROCEDURE. THE CASE CONTINUED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19215196 ↗
• MalfunctionMar 22, 2024Material Protrusion/Extrusion; Material Twisted/Bent; Material Protrusion/Extrusion; Material Twisted/Bent

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A CELSIUS¿ ELECTROPHYSIOLOGY CATHETER AND WHEN OPENING THE PACKAGE, UPON VISUAL INSPECTION, THE CATHETER APPEARED DEFECTIVE ON THE CATHETER TIP, JUST BELOW PROXIMAL ELECTRODES. THERE WAS A BEND AT THE DISTAL PORTION AND BRAIDING EXPOSED. THE CATHETER WAS NOT INSERTED IN PATIENT. THE CATHETER WAS REPLACED. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18957051 ↗
• MalfunctionMar 21, 2024Signal Artifact/Noise; Material Deformation; Signal Artifact/Noise; Material Deformation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIOVENTRICULAR NODAL REENTRANT TACHYCARDIA (AVNRT) ABLATION PROCEDURE WITH A CELSIUS¿ ELECTROPHYSIOLOGY CATHETER AND THE DISTAL ELECTRODE¿S PLASTIC PADDING WAS FRAYED. IT WAS REPORTED THERE WERE NO ISSUES WHEN THE CELSIUS¿ ELECTROPHYSIOLOGY CATHETER WAS CONNECTED TO THE SMARTABLATE GENERATOR. WHEN THE PHYSICIAN INSERTED THE CATHETER INTO THE PATIENT¿S BODY WE HAD SEVERE NOISE ON THE DISTAL ELECTRODE SO MUCH SO THAT THE DISTAL ELECTRODE¿S ELECTROGRAMS WEREN¿T DISTINCT AND VISIBLE. THEY TRIED TO DETECT IF THERE WAS ANY ELECTROMAGNETIC INTERFERENCE BUT EVERYTHING SEEMED FINE. THEY CHECKED THE GAIN AND THE SELECTED SETTINGS ON THE RECORDING SYSTEM BUT EVERYTHING SEEMED FINE. THEY REPLACED THE CATHETER¿S CABLE WITH A NEW ONE BUT THE PROBLEM WAS NOT RESOLVED. AFTERWARDS, WE REMOVED THE CATHETER FROM THE PATIENT¿S BODY TO VISUALLY INSPECT THE CATHETER¿S TIP. THEY DETECTED THAT THE DISTAL ELECTRODE¿S PLASTIC PADDING WAS FRAYED AND ALSO THE DISTAL ELECTRODE SEEMED SCRATCHED. FINALLY, WE REPLACED THE ABLATION CATHETER WITH A NEW ONE AND THE PROBLEM EVENTUALLY HAS BEEN SOLVED. THE PROCEDURE CONTINUED WITHOUT ANY FURTHER INCIDENT AND NO HARM TO THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18956741 ↗
• MalfunctionDec 14, 2023Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNSPECIFIED ABLATION PROCEDURE WITH A CELSIUS¿ ELECTROPHYSIOLOGY CATHETER AND DURING THE PRODUCT CHECK THE PHYSICIAN FOUND ISSUES WITH THE TIP. THE CURVE WAS MORE DRAMATIC THAN USUAL AND THE PHYSICIAN WORRIED THAT IT WOULDN'T REMAIN STABLE DURING ABLATION AND WOULD CONTACT THE ATRIOVENTRICULAR (AV) NODE. THE PHYSICIAN DID NOT USE THIS DEVICE. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18331169 ↗
• MalfunctionDec 14, 2023Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNSPECIFIED ABLATION PROCEDURE WITH A CELSIUS¿ ELECTROPHYSIOLOGY CATHETER AND DURING THE PRODUCT CHECK THE PHYSICIAN FOUND ISSUES WITH THE TIP. THE CURVE WAS MORE DRAMATIC THAN USUAL AND THE PHYSICIAN WORRIED THAT IT WOULDN'T REMAIN STABLE DURING ABLATION AND WOULD CONTACT THE ATRIOVENTRICULAR (AV) NODE. THE PHYSICIAN DID NOT USE THIS DEVICE. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18331131 ↗
• MalfunctionDec 14, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL TACHYCARDIA RIGHT (R-AT) PROCEDURE WITH A CELSIUS¿ ELECTROPHYSIOLOGY CATHETER AND A WIRES EXPOSED ISSUE OCCURRED. THE PHYSICIAN UNPACKED THE PRODUCT TO USE IN THE PROCEDURE. THEN HE FOUND THAT THE TIP OF THE CATHETER HAD MORE CURLINESS THAN USUAL. THEREFORE, THE PHYSICIAN HAD A CONCERN ABOUT SAFETY OF THE PATIENT. THEY SENT BACK THE PRODUCT TO THE COMPANY FOR INVESTIGATION. THEY COULD NOT FIND IN THE CATALOG THE DETAIL ABOUT THE CURVE DEGREE OF CATHETER TIP BEFORE NOD ADJUST. THERE WAS NO PATIENT CONSEQUENCE. ADDITIONAL INFORMATION WAS RECEIVED ON 09-OCT-2023. THIS COMPLAINT WAS FOUND BEFORE THE PROCEDURE AT OPENING. THE PRODUCT HAD NOT BEEN USED. ADDITIONAL INFORMATION WAS RECEIVED ON 16-NOV-2023. THE DAMAGE RESULTED IN WIRES BEING EXPOSED. USER INSPECTED BY EYE BEFORE INSERTION. CURVE WAS WEIRD MORE THAN AS USUAL AND PHYSICIAN CONCERNED IF CATHETER WAS TO BE INSERTED INTO THE HEART. OR WITH THE CURVE LIKE THIS DURING ABLATION, CURVE WILL NOT BE STABLE AND IT MIGHT TOUCH THE ATRIOVENTRICULAR (AV) NODE. THIS EVENT WAS ORIGINALLY CONSIDERED NON-REPORTABLE, HOWEVER, BWI BECAME AWARE THAT WIRES WERE EXPOSED ON 16-NOV-2023 AND HAVE REA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18330067 ↗
• MalfunctionNov 8, 2023Manufacturing, Packaging or Shipping Problem; Material Protrusion/Extrusion; Manufacturing, Packaging or Shipping Problem; Material Protrusion/Extrusion

  IT WAS REPORTED THAT PRIOR TO A PATIENT'S ABLATION PROCEDURE, THE MEDICAL TEAM DISCOVERED THAT THE CELSIUS¿ ELECTROPHYSIOLOGY CATHETER THEY HAD INTENDED TO USE HAD A PHYSICAL ABNORMALITY AT THE CATHETER'S DISTAL END. THE PHYSICIAN IDENTIFIED THE FOLLOWING ISSUE THROUGH THE PACKING WINDOW: THERE WAS A RIDGE/HUMP AT THE CATHETER'S TIP (PROXIMAL TO ELECTRODES). THE DEVICE WAS NOT USED ON THE PATIENT. NO FURTHER DETAILS WERE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18094586 ↗
• MalfunctionSep 18, 2023Positioning Failure; Material Protrusion/Extrusion; Positioning Failure; Material Protrusion/Extrusion

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A CELSIUS¿ ELECTROPHYSIOLOGY CATHETER. AFTER CONNECTING THE CATHETER TO A ST. JUDE MEDICAL RADIOFREQUENCY (RF) GENERATOR AND RECORDING SYSTEM, THE PHYSICIAN INSERTED THE CATHETER INTO THE PATIENT. SOMETHING ABNORMAL WAS SEEN ON THE XRAY SO THE PHYSICIAN REMOVED THE CATHETER FROM THE PATIENT. THE PHYSICIAN DEFLECTED THE CATHETER, AND THE CURVE APPEARED ABNORMAL. WHEN CHECKING THE CATHETER CLOSELY, IT APPEARED TO BE DEFECTIVE. THE CATHETER IS NOT COATED AND WIRES CAN BE SEEN. THERE WERE NO LIFTED NOR SHARP RINGS AND THERE WAS NO RESISTANCE DURING INSERTION AND REMOVAL OF THE CATHETER. THE ISSUE WITH THE CURVE OF THE CATHETER WAS ASSESSED AS NOT MDR REPORTABLE. THE POTENTIAL THAT IT COULD CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY, OR OTHER SIGNIFICANT ADVERSE EVENT, IS REMOTE. THE WIRES EXPOSED ISSUE IS MDR REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17765937 ↗
• MalfunctionAug 22, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABLATION PROCEDURE WITH A CELSIUS¿ ELECTROPHYSIOLOGY CATHETER AND THERE IS SOME OF THE BLUE PLASTIC COATING MISSING AT THE TIP. THE TIP OF THE CELSIUS¿ ELECTROPHYSIOLOGY CATHETER SHOULD BE STRAIGHT, BUT THIS CATHETER THE TIP IS BENT. IN ADDITION, THERE IS SOME OF THE BLUE PLASTIC COATING MISSING AT THE TIP. NO PATIENT CONSEQUENCE. ADDITIONAL INFORMATION WAS RECEIVED. THE CALLER DID NOT SUPPORT THIS CASE. IT WAS A CASE PERFORMED BY THE PHYSICIAN WITHOUT SUPPORT BY THE BIOSENSE WEBSTER, INC. TEAM. THAT IS WHY THE CALLER CANNOT PROVIDE THE SPECIFIC DAY OF PROCEDURE. BUT THE CALLER IS SURE THAT THEY PERFORMED THE PROCEDURE ONLY A FEW DAYS BEFORE THE CALLER RECEIVED THE CATHETER WITH THE ISSUE. THERE WERE NO WIRES EXPOSED. THE TIP WAS JUST BENT LIKE IT WAS KIND OF PRE-SHAPED, COMPARABLE FOR EXAMPLE LIKE THE CARDIAGUIDE IS PRE-SHAPED WITH AN ANGLE. AS THERE WAS SOME OF THE PLASTIC COATING AT THE CATHETER TIP MISSING, SOME OF THE ELECTRODES WERE MORE EXPOSED THAN THEY SHOULD BE. THE CALLER BELIEVES THEY SAW THE DAMAGE BEFORE INSERTION OF THE CATHETER. THE CALLER ALREADY SENT THE CATHETER IN AND THEREFORE, UNABLE TO TAKE A PICTURE. THE CATHETER W

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17595887 ↗
• MalfunctionAug 11, 2023Manufacturing, Packaging or Shipping Problem; Material Protrusion/Extrusion; Material Twisted/Bent; Manufacturing, Packaging or Shipping Problem; Material Protrusion/Extrusion; Material Twisted/Bent

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIOVENTRICULAR NODAL ABLATION PROCEDURE WITH A CELSIUS¿ ELECTROPHYSIOLOGY CATHETER AND THE DEVICE WAS BENT WITH A GAP THAT EXPOSED INTERNAL METALS. IT WAS REPORTED THAT WHEN THE CELSIUS¿ ELECTROPHYSIOLOGY CATHETER WAS REMOVED FROM THE PACKAGING, THE CATHETER WAS DISCOVERED TO BE VISIBLY BENT. THE CALLER STATED THAT THERE WAS A GAP IN THE BLUE MATERIAL ON THE CELSIUS¿ ELECTROPHYSIOLOGY CATHETER AND METAL WAS EXPOSED. THEY REPLACED THE CATHETER AND THE PROCEDURE CONTINUED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17511085 ↗
• MalfunctionApr 12, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABLATION PROCEDURE WITH A CELSIUS¿ ELECTROPHYSIOLOGY CATHETER AND A FOREIGN MATERIAL ON THE USABLE LENGTH OF THE CATHETER ISSUE OCCURRED. THE PHYSICIAN COMPLAINED THAT SOME STRANGE MATERIAL (PROBABLY PLASTIC) WAS PRESENT AT THE TIP OF THE CATHETER AND FOR SAFETY REASONS HE DECIDED TO UNPACK A NEW CATHETER. THE SURGERY WAS DELAYED 3 MINUTES DUE TO THE REPORTED ISSUE. THE ACTION TAKEN WHEN THE EVENT OCCURRED WAS TO CHANGE THE CATHETER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED. THE REPORTER WAS UNABLE TO SEE THE MATERIAL BECAUSE NO CLINICAL SUPPORT WAS PRESENT WHEN THIS OCCURRED. ALL PACKAGING MATERIALS WERE DISCHARGED WHEREAS THE CATHETER WAS SENT BACK. THE CATHETER WAS NOT USED ON THE PATIENT. THE EVENT WAS ASSESSED AS MDR REPORTABLE FOR FOREIGN MATERIAL ON THE USABLE LENGTH OF THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16728594 ↗
• MalfunctionOct 20, 2022Product Quality Problem; High Readings; Material Split, Cut or Torn; Product Quality Problem; High Readings; Material Split, Cut or Torn

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABLATION PROCEDURE WITH A CELSIUS¿ ELECTROPHYSIOLOGY CATHETER AND IT WAS OBSERVED THAT THE CATHETER DID NOT HAVE A COATING ON THE DISTAL PORTION. THE CATHETER DOES NOT HAVE A COATING ON THE DISTAL PORTION, SO IT DID NOT MARK IMPEDANCES OR IT MARKED HIGH IMPEDANCES. THE SURGERY WAS DELAYED 10 MINUTES DUE TO THE REPORTED EVENT. THE CATHETER WAS CHANGED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS RECEIVED. THE MATERIAL WAS CLOSED WHEN RECEIVED AT THE FACILITY. THE FAULT IS IDENTIFIED WHEN USING IT. SHEATH WAS NOT USED. THE DEVICE WAS USED ON THE PATIENT. IN PHYSICIAN¿S OPINION, THE DELAY DID NOT CONTRIBUTE TO A DEATH OR A SERIOUS INJURY TO THE PATIENT. INTERVENTION WAS NOT REQUIRED DUE TO THE DELAY. ABLATION COULD NOT BE GIVEN. TEMPERATURE WAS 50, WATTS 35, AND HIGH IMPEDANCE. ADDITIONAL FOLLOW UP HAS BEEN REQUESTED TO CLARIFY EVENT DESCRIPTION AND REGARDING RESPONSE TO FRAGMENTS QUESTION OF, ¿IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? YES,¿. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE. WITH THE INFORMATION AVAILABLE, THE ISSUE OF THE ¿C

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15636816 ↗
• MalfunctionSep 30, 2022Device Contamination with Body Fluid; High Readings; Device Contamination with Body Fluid; High Readings

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PROCEDURE WITH A CELSIUS¿ ELECTROPHYSIOLOGY CATHETER AND THE BIOSENSE WEBSTER INC. PRODUCT ANALYSIS LAB OBSERVED ELECTRODE #1 AND ELECTRODE #4 INVERTED. INITIALLY IT WAS REPORTED THAT THE CELSIUS¿ ELECTROPHYSIOLOGY CATHETER WAS DEFECTIVE. UPON THE CONNECTION TO THE SMARTABLATE GENERATOR, IMPEDANCE VALUES WERE OFF, EXCEEDING A VALUE OF 250. ABLATION WAS IMPOSSIBLE DUE TO IMPEDANCE CUT OFF OF 250. WHEN WITHDRAWN FROM THE PATIENT, THE CUSTOMER NOTICED A CHARRING LIKE STAIN ON ELECTRODES 3 AND 4. DUE TO THE IMPEDANCE ISSUE AND VISIBLE ERROR ON ELECTRODES, THE CATHETER WAS REPLACED WITH A NEW ONE AND THE PROCEDURE PERFORMED SUCCESSFULLY WITH NEW CATHETER. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THE SURGERY WAS NOT DELAYED DUE TO THE REPORTED EVENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. ADDITIONAL INFORMATION WAS RECEIVED. THE SYSTEM PRESENTED AN ERROR MESSAGE. IMPEDANCE READINGS WERE UNPHYSIOLOGICAL AND GENERATOR PREVENTED ABLATION. THE GENERATOR WAS SET TO TEMPERATURE CONTROL MODE WITH TEMPERATURE CUT OFF AT 95. TEMPERATURE AND POWER WERE NOT PROVIDED. IMPEDANCE EXCEEDED 250. THE PHYSICIAN CONSIDERED THAT THE CHAR WAS EXCESSIVE. THE PHY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15513548 ↗
• MalfunctionSep 11, 2022Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED THAT AN UNKNOWN PATIENT UNDERWENT AN UNKNOWN ABLATION PROCEDURE WITH A CELSIUS¿ ELECTROPHYSIOLOGY CATHETER. THERE WAS IMPROPER MARGINS BETWEEN ELECTRODE 2 AND 3. THERE WAS AN IMPROPER SHAFT SURFACE, IN BETWEEN ELECTRODE 2 AND 3. CATHETER WAS NOT INSERTED INTO THE PATIENT TO AVOID ANY POSSIBLE DAMAGE. THERE WAS A ROUGH BUMP VISIBLE IN BETWEEN ELECTRODE 2&3. THERE WERE NO WIRES EXPOSED AND THERE WAS NO LIFTED OR SHARP RINGS/ELECTRODES/PARTS. NO PATIENT CONSEQUENCES. ELECTRODE DAMAGE WITH SHARP/ROUGH EDGES IS MDR-REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15397856 ↗

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