N/A R10439011Recalls & reported problems

Summary

The FDA's MAUDE database contains 45 adverse event reports that list this exact device (DI 10888551045087), received between Jun 9, 2020 and Mar 23, 2026 — classified as 4 injuries, 41 malfunctions.

The most frequently reported specific device problem is “Defective Device” (6 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, 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 45 reports, in the reporter's own words as published by the FDA.

• InjuryMar 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A RIGHT SIDED IDIOPATHIC VENTRICULAR TACHYCARDIA ABLATION WITH A REPROCESSED SOUNDSTAR CATHETER AND THE PATIENT EXPERIENCED CARDIAC PERFORATION/PERICARDIAL EFFUSION THAT REQUIRED PERICARDIOCENTESIS. AFTER CREATING A CARTOSOUND MAP THEN MAPPING THE RV (RIGHT VENTRICLE) WITH THE QDOT CATHETER, THE PHYSICIAN NOTED THAT THE STERILMED SOUNDSTAR DID NOT LOOK LIKE IT WAS IN THE CORRECT PLACE, POSSIBLY PERFORATING THE RV. A PERICARDIAL EFFUSION WAS VISUALIZED USING THE STERILMED SOUNDSTAR CATHETER. A PERICARDIOCENTESIS WAS PERFORMED REMOVING 250 ML OF FLUID. THE PATIENT WAS STABLE. THE PROCEDURE WAS NOT COMPLETED. NO RF (RADIOFREQUENCY) OR TRANSSEPTAL WAS PERFORMED PRIOR TO THE EFFUSION. THE STERILMED DEVICE FUNCTIONED AS EXPECTED. PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT IS INTRACARDIAC ECHOCARDIOGRAM CATHETER (SOUNDSTAR) PERFORATION OF THE RV.

  Patient problems: Cardiac Perforation

  MAUDE report 24670917 ↗
• MalfunctionFeb 26, 2026Contamination /Decontamination Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION WITH A REPROCESSED SOUNDSTAR® CATHETER AND AFTER THE STAFF OPENED THE PACKAGING, THEY FOUND A STICKER, ABOUT EIGHT INCHES FROM THE TOP ON THE CATHETER, THAT WAS VERY STICKY. THE STICKINESS WAS ALL OVER THE CATHETER. THE CATHETER WAS REPLACED, AND THE PROBLEM WAS RESOLVED. THE CASE CONTINUED. THERE WAS NO PATIENT CONSEQUENCES REPORTED. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION TO THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24463891 ↗
• MalfunctionAug 14, 2025Delivered as Unsterile Product; Packaging Problem; Delivered as Unsterile Product; Packaging Problem

  IT WAS REPORTED THAT SEVERAL BOXES OF REPROCESSED SOUNDSTAR ECO 8F DIAGNOSTIC ULTRASOUND CATHETERS WERE RECEIVED WITH EXTENSIVE WATER DAMAGE. THE OUTER SHIPPING BOX WAS WET AND SOME OF THE WHITE PRODUCT BOXES INSIDE THE SHIPPING BOXES WERE WET AS WELL. UPON INSPECTION OF THE PRODUCT INSIDE THE WET WHITE BOXES, SEVERAL HAD WATER DROPLETS OUTSIDE AND INSIDE THE STERILE PACKAGING. THE WHITE BOXES WERE VISIBLY DISCOLORED FROM THE WATER/LIQUID.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22812204 ↗
• MalfunctionAug 14, 2025Delivered as Unsterile Product; Packaging Problem; Delivered as Unsterile Product; Packaging Problem

  IT WAS REPORTED THAT SEVERAL BOXES OF REPROCESSED SOUNDSTAR ECO 8F DIAGNOSTIC ULTRASOUND CATHETERS WERE RECEIVED WITH EXTENSIVE WATER DAMAGE. THE OUTER SHIPPING BOX WAS WET AND SOME OF THE WHITE PRODUCT BOXES INSIDE THE SHIPPING BOXES WERE WET AS WELL. UPON INSPECTION OF THE PRODUCT INSIDE THE WET WHITE BOXES, SEVERAL HAD WATER DROPLETS OUTSIDE AND INSIDE THE STERILE PACKAGING. THE WHITE BOXES WERE VISIBLY DISCOLORED FROM THE WATER/LIQUID.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22812203 ↗
• MalfunctionAug 14, 2025Delivered as Unsterile Product; Packaging Problem; Delivered as Unsterile Product; Packaging Problem

  IT WAS REPORTED THAT SEVERAL BOXES OF REPROCESSED SOUNDSTAR ECO 8F DIAGNOSTIC ULTRASOUND CATHETERS WERE RECEIVED WITH EXTENSIVE WATER DAMAGE. THE OUTER SHIPPING BOX WAS WET AND SOME OF THE WHITE PRODUCT BOXES INSIDE THE SHIPPING BOXES WERE WET AS WELL. UPON INSPECTION OF THE PRODUCT INSIDE THE WET WHITE BOXES, SEVERAL HAD WATER DROPLETS OUTSIDE AND INSIDE THE STERILE PACKAGING. THE WHITE BOXES WERE VISIBLY DISCOLORED FROM THE WATER/LIQUID.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22812200 ↗
• MalfunctionAug 14, 2025Delivered as Unsterile Product; Packaging Problem; Delivered as Unsterile Product; Packaging Problem

  IT WAS REPORTED THAT SEVERAL BOXES OF REPROCESSED SOUNDSTAR ECO 8F DIAGNOSTIC ULTRASOUND CATHETERS WERE RECEIVED WITH EXTENSIVE WATER DAMAGE. THE OUTER SHIPPING BOX WAS WET AND SOME OF THE WHITE PRODUCT BOXES INSIDE THE SHIPPING BOXES WERE WET AS WELL. UPON INSPECTION OF THE PRODUCT INSIDE THE WET WHITE BOXES, SEVERAL HAD WATER DROPLETS OUTSIDE AND INSIDE THE STERILE PACKAGING. THE WHITE BOXES WERE VISIBLY DISCOLORED FROM THE WATER/LIQUID.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22812199 ↗
• MalfunctionJun 10, 2025Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A REPROCESSED SOUNDSTAR ECO 8F DIAGNOSTIC ULTRASOUND CATHETER AND THE CATHETER CURLED IN THE LOWER ABDOMEN WHEN INSERTED INTO THE PATIENT. THE CATHETER WAS UNABLE TO UNCURL. AN ATTEMPT WAS MADE TO STRAIGHTEN OUT THE CATHETER BY ADVANCING TO THE RIGHT ATRIUM AND PULLING BACK TO THE INFERIOR VENA CAVA. HOWEVER, THE CATHETER HAD TO BE REMOVED BY REMOVING THE SHEATH AND CATHETER. THERE WAS A 20-MINUTE DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT INJURY OR CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22176413 ↗
• MalfunctionNov 20, 2024

  SOUNDSTAR INSERTED INTO BODY, CATHETER SENSOR ERROR. PRODUCT REMOVED. NO HARM TO PATIENT. DIFFERENT CATHETER OPENED. PROBLEM SOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20733691 ↗
• InjuryOct 31, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN IDIOPATHIC VENTRICULAR PVC (PREMATURE VENTRICULAR CONTRACTION) ABLATION PROCEDURE WITH A QDOT MICRO CATHETER, AND THE PATIENT EXPERIENCED CARDIAC PERFORATION THAT REQUIRED PERICARDIOCENTESIS AND SURGICAL INTERVENTION. DURING THE PROCEDURE, THE PVC TERMINATED DURING RADIOFREQUENCY AND THE SURROUNDING AREA WAS ABLATED. POST USE OF BIOSENSE WEBSTER PRODUCTS, A PERICARDIAL EFFUSION WAS DIAGNOSED VIA INTRACARDIAC ECHOCARDIOGRAPHY (ICE) WITH A SOUNDSTAR CATHETER AFTER THE PHYSICIAN NOTED THAT THE EFFUSION WAS NOT THERE AT BASELINE. A PERICARDIOCENTESIS WAS PERFORMED BY THE PHYSICIAN. THE PATIENT WAS STABLE. HOWEVER, THE PATIENT WORSENED HEMODYNAMICALLY AFTER TRANSFER TO THE INTENSIVE CARE UNIT. PATIENT WENT FOR CARDIOTHORACIC SURGERY TO SURGICALLY REPAIR THE PERFORATION IN THE LV (LEFT VENTRICULAR) APEX. THE PATIENT LEFT THE OPERATING ROOM STABLE. THE PATIENT REQUIRED EXTENDED HOSPITALIZATION. THE PHYSICIAN'S OPINION ON THE CAUSE OF THE ADVERSE EVENT IS THE PROCEDURE, IT IS THOUGHT TO HAVE OCCURRED DURING THE ABLATION PHASE. NO EVIDENCE OF STEAM POP. NO ERROR MESSAGES OBSERVED ON BIOSENSE WEBSTER EQUIPMENT DURING THE PROCEDURE.

  Patient problems: Cardiac Tamponade

  MAUDE report 20584321 ↗
• MalfunctionOct 31, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A REPROCESSED SOUNDSTAR ECO 8F DIAGNOSTIC ULTRASOUND CATHETER AND WHEN THE TRAY WAS OPENED, THE TIP DOME PORTION OF THE CATHETER SLID OFF. THERE WAS NO DAMAGE TO THE PACKAGING. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20583346 ↗
• MalfunctionOct 23, 2024

  CATHETER INSERTED AND WOULD NOT APPEAR ON COMPUTER SCREEN. EXCHANGED FOR NEW CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20513842 ↗
• MalfunctionOct 14, 2024Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT PRIOR TO AN ATRIAL FIBRILLATION PROCEDURE WITH A REPROCESSED SOUNDSTAR ECO 8F DIAGNOSTIC ULTRASOUND CATHETER, DAMAGES TO THE PACKAGING OF THE CATHETER WERE NOTICED. WHEN THE CATHETER WAS REMOVED FROM THE BOX, A BIG HOLE WAS DISCOVERED ON THE POUCH OF THE PACKAGING. THERE WAS NO VISIBLE DAMAGE TO THE CATHETER AND THE CATHETER WAS NOT REMOVED FROM THE PACKAGING. IT IS UNKNOWN HOW OR WHEN THE DAMAGES TO THE PACKAGING OCCURRED. THE DAMAGE COMPROMISED THE STERILITY OF THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20446731 ↗
• MalfunctionOct 7, 2024

  ULTRASOUND CATHETER IMAGE BECAME UNCLEAR - INTERFERENCE. ERROR MESSAGE PRESENT ON CARTO CONSOLE. WHILE IN BODY. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20383048 ↗
• MalfunctionSep 27, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PAROXYSMAL ATRIAL FIBRILLATION ABLATION PROCEDURE WITH A REPROCESSED SOUNDSTAR ECO 8F DIAGNOSTIC ULTRASOUND CATHETER AND UPON OPENING THE SOUNDSTAR CATHETER, SOME DAMAGE WAS OBSERVED TO THE PLASTIC COATING ON THE SHAFT OF THE CATHETER, EXPOSING INTERNAL MATERIAL. IT WAS BELIEVED THAT THIS DAMAGE WOULD AFFECT INSERTION AND POSE A RISK OF A PIECE OF THE COATING COMING OFF INSIDE THE PATIENT. THEREFORE, A SECOND REPROCESSED SOUNDSTAR WAS OPENED TO COMPLETE THE PROCEDURE. THE DEVICE WAS NOT USED ON THE PATIENT. THERE WAS NO PHYSICAL DAMAGE OBSERVED ON THE PACKAGING. THERE WAS A 15-MINUTE DELAY TO THE PROCEDURE FOR TROUBLESHOOTING THIS EVENT AND ANOTHER NOT REPORTABLE ISSUE WITH ANOTHER CATHETER. THE PHYSICIAN DID NOT FEEL THE PROCEDURAL DELAY WAS CLINICALLY SIGNIFICANT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20321402 ↗
• MalfunctionApr 16, 2024

  SOUNDSTAR ICE (INTRACARDIAC ECHOCARDIOGRAPHY) CATHETER HAD A SENSOR CATHETER ERROR. REMOVED FROM BODY AND NEW CATHETER INSERTED. RESOLVED ISSUE. NO HARM TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19115025 ↗
• MalfunctionApr 16, 2024

  ICE (INTRACARDIAC ECHOCARDIOGRAPHY) CATHETER INSERTED BUT SHOWED SENSOR ERROR. CATHETER REMOVED AND REPLACED. NO HARM TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19114851 ↗
• MalfunctionMar 29, 2024

  ICE (INTRACARDIAC ECHOCARDIOGRAPHY) CATHETER INSERTED. SENSOR ERROR NOTED. CATHETER REMOVED. THEN REPLACED WITH NEW ONE. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19002800 ↗
• MalfunctionDec 15, 2023

  ICE (INTRACARDIAC ECHOCARDIOGRAPHY) MACHINE READING WHEN ICE CATHETER CONNECTED: "NOT SUPPORTED". NO HARM TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18334280 ↗
• MalfunctionJun 27, 2023Erratic or Intermittent Display; Defective Device; Protective Measures Problem

  SOUNDSTAR ECO DIAGNOSTIC ULTRASOUND CATHETER "ICE" CATHETER WAS IN USE, THEN FROZE ON THE SCREEN AND MESSAGE SAID: "NO TRANSDUCER". WE TRIED UNPLUGGING AND PLUGGING IN AGAIN, RESTARTING THE MACHINE, TRYING A NEW DONGLE. WHEN WE GOT A NEW CATHETER, THE ERROR MESSAGE WENT AWAY, SO IT WAS DEDUCED THAT THE CATHETER STOPPED WORKING. THE PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17208379 ↗
• MalfunctionJun 9, 2023No Display/Image

  ICE (INTRACARDIAC ECHOCARDIOGRAPHY) CATHETER INSERTED BUT DID NOT SHOW ON SCREEN. CABLE REPLACED. THEN CATHETER REPLACED. NO HARM TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17097181 ↗
• MalfunctionMay 30, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH A REPROCESSED SOUNDSTAR ECO 8F DIAGNOSTIC ULTRASOUND CATHETER AND WHEN THE CATHETER WAS REMOVED FROM THE PACKAGING, THERE WAS SOME PLASTIC MELTED ONTO THE TIP OF THE CATHETER. THE PACKAGE WAS OPENED DURING PREP FOR THE SURGERY WHILE THE PATIENT WAS ON THE TABLE. THERE WAS NO PHYSICAL DAMAGE, OR ANY OTHER ISSUE OBSERVED ON THE PACKAGE OF THE DEVICE. THE CATHETER WAS REPLACED, AND THE PROCEDURE CONTINUED WITHOUT FURTHER ISSUES. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17020700 ↗
• MalfunctionMar 23, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN IDIOPATHIC VENTRICULAR TACHYCARDIA (IDVT) PROCEDURE WITH A SOUNDSTAR ECO 8F DIAGNOSTIC ULTRASOUND CATHETER AND A FOREIGN MATTER INSIDE THE PACKAGING ISSUE OCCURRED. INSIDE THE STERILE PACKAGING OF THE REPROCESSED CATHETER, IT HAD SOME BLACK SPECKS OF A FOREIGN SUBSTANCE. THEY COULD SEE IT THROUGH THE PACKAGING SO THEY DECIDED NOT TO OPEN IT. THE CATHETER WAS REPLACED WITH ANOTHER REPROCESSED CATHETER AND THE ISSUE WAS RESOLVED. THIS IS THE ONLY CATHETER THAT THEY FOUND TO HAVE THIS ISSUE IN THE ACCOUNT INVENTORY. THE PROCEDURE CONTINUED. THERE WAS NO PATIENT CONSEQUENCE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED. THE CATHETER WITH THE LOT NUMBER OF 2176602 HAD THE FOREIGN SUBSTANCE IN STERILE PACKAGE ISSUE. THE BOX WAS OPENED, BUT NOT THE STERILE PACKAGING. THERE WAS NO PHYSICAL DAMAGE OR ANY OTHER ISSUE OBSERVED ON THE PACKAGE OF THE DEVICE WITH THE FOREIGN SUBSTANCE (OUTER BOX, TRAY, POUCH). THE FOREIGN SUBSTANCE WAS LOOSE IN THE PACKAGE, NOT ON THE DEVICE. PICTURES ARE NOT AVAILABLE, BUT PACKAGE WAS UNOPENED. THE CATHETER WAS LEFT IN THE STERILE PACKAGING. THE OUTER BOX IS NOT AVAILABLE. THE EVENT WAS ASSESSED AS MDR REPORTABLE FOR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16598965 ↗
• InjuryMar 9, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A SOUNDSTAR ECO 8F DIAGNOSTIC ULTRASOUND CATHETER. THE PATIENT SUFFERED AN AIR EMBOLISM AND ELECTROCARDIOGRAM ST SEGMENT ELEVATION. DURING THE PROCEDURE, AN ADVERSE EVENT OCCURRED. THE PHYSICIAN PLACED A DECANAV ELECTROPHYSIOLOGY CATHETER IN THE CF AND REPROCESSED STERILMED SOUNDSTAR CATHETER IN THE RIGHT ATRIUM FOR TRANSSEPTAL ACCESS. THEY REPORTED THEY ALSO USED A TORFLEX TRANSSEPTAL GUIDING SHEATH AND A SAFESTEP NEEDLE AS WELL. THE PHYSICIAN WAS NOT SUCCESSFUL IN DOING THE TRANSSEPTAL WITH THE SAFESTEP NEEDLE AND EXCHANGED IT FOR THE BAYLIS RF LARGE-CURVE TRANSSEPTAL NEEDLE (NRG-E-HF-71-C1). THE PHYSICIAN'S BAYLIS NEEDLE-MAPPED THE LEFT ATRIUM WITH AN OCTARAY CATHETER AND THE PHYSICIAN PULLED BACK THE SHEATH AND HAD A WIRE ACROSS THE TRANSSEPTAL AND HE WAS GETTING READY TO SEND ACROSS A SECOND NEEDLE WHEN THE ANESTHESIA TEAM REPORTED THAT THE PATIENT WAS HYPOTENSIVE. THE ECG SHOWED ST ELEVATION. THE PHYSICIAN AND STAFF THEN PERFORMED A TEE ULTRASOUND AND THE PHYSICIAN CONCLUDED THAT AIR HAD GOTTEN INTO THE LEFT SIDE OF THE BODY AND THERE WAS AN AIR EMBOLUS IN THE APEX OF THE LEFT VENTR

  Patient problems: Air Embolism

  MAUDE report 16519420 ↗
• MalfunctionJan 13, 2023Material Twisted/Bent; Positioning Problem; Material Twisted/Bent; Positioning Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN IDIOPATHIC VENTRICULAR TACHYCARDIA (IDVT) PROCEDURE WITH A SOUNDSTAR ECO 8F DIAGNOSTIC ULTRASOUND CATHETER AND THE STERILMED INC. PRODUCT ANALYSIS LAB OBSERVED THE SHAFT MATERIAL SEEMED TO BE CRACKED, BURRED, BARELY EXPOSING THE INTERNAL CATHETER COMPONENTS. INITIALLY IT WAS REPORTED THAT THE SOUNDSTAR ECO 8F DIAGNOSTIC ULTRASOUND CATHETER WAS NOT MOVING OR STEERING CORRECTLY. THE SOUNDSTAR ECO 8F DIAGNOSTIC ULTRASOUND CATHETER WAS REMOVED FROM THE BODY AND IT WAS NOTICED THAT THE SOUNDSTAR ECO 8F DIAGNOSTIC ULTRASOUND CATHETER SPLINE WAS BENT AT THE DISTAL TIP. THE SOUNDSTAR ECO 8F DIAGNOSTIC ULTRASOUND CATHETER WAS REPLACED AND THE ISSUE RESOLVED. THE PROCEDURE CONTINUED. THERE WAS NO PATIENT CONSEQUENCE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED. THE PRIMARY PACKAGING BOX WAS OPENED BEFORE THE SURGERY AND DISCARDED. ALL THE PACKAGES WERE DISCARDED. THE LAB OPENED ON THE TABLE AND DISCARDED ALL PACKAGING BEFORE. THE PHYSICIAN WAS DELAYED THAT DAY AND THE TRASH WAS ALREADY IN THE COMPACTOR. THERE WAS NO COMPLAINT ON ANY PHYSICAL DAMAGE OR ANY OTHER ISSUE OBSERVED ON THE PACKAGE OF THE DEVICE (OUTER BOX, TRAY, POUCH). THE DEFLECTION IS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16159029 ↗
• MalfunctionNov 17, 2022Poor Quality Image

  IMAGE QUALITY NOT ACCEPTABLE. GRAINY. IN BODY. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15814381 ↗