ICEfx Cryoablation System FPRCH8000Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00859019006370), received between Dec 20, 2018 and Mar 2, 2026 — classified as 2 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Insufficient Cooling” (7 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Aug 18, 2025Class IIOpen, Classified

   Certain desiccant tube subassemblies were built with end caps that were not correctly tightened.

   Z-2550-2025 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 2, 2026Human-Device Interface Problem

  IT WAS REPORTED THE PROCEDURE WAS CANCELLED DUE A SYSTEM MALFUNCTION. AN ICEFX CRYOABLATION SYSTEM WAS CHOSEN FOR A CRYOABLATION PROCEDURE. DURING PREPARATION PRIOR TO THE PROCEDURE, SIX ICEFORCE 2.1 CX 90 DEGREE NEEDLE WERE CONNECTED TO THE ICEFX CRYOABLATION SYSTEM AND ENCOUNTERED ITHAW MALFUNCTION ERRORS. EACH OF THE SIX ICEFORCE 2.1 CX 90 DEGREE NEEDLES WAS SWITCHED TO ANOTHER CHANNEL ON THE ICEFX CRYOABLATION SYSTEM. HOWEVER, THIS DID NOT RESOLVE THE ITHAW MALFUNCTION. THE PROCEDURE WAS CANCELLED DUE TO THIS ICEFX CRYOABLATION SYSTEM MALFUNCTION. PATIENT SEDATION AT THE TIME OF PROCEDURE CANCELLATION IS UNKNOWN. AFTER THE PROCEDURE WAS CANCELLED, THE SOFTWARE OF THE ICEFX CRYOABLATION SYSTEM WAS UPDATED AND THE SYSTEM WAS RESTARTED, AND THE SYSTEM MALFUNCTION WAS RESOLVED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24490489 ↗
• MalfunctionJan 8, 2026Human-Device Interface Problem

  IT WAS REPORTED THE PROCEDURE WAS CANCELLED DUE A CRYOABLATION SYSTEM MALFUNCTION. A ICEFX CRYOABLATION SYSTEM WAS CHOSEN TO FOR A CRYOABLATION PROCEDURE. DURING PREPARATION PRIOR TO THE PROCEDURE, THE CONSOLE SYSTEM DISPLAYED AN '80-01' ERROR MESSAGE. THE PROCEDURE WAS CANCELLED/RESCHEDULED DUE TO THE ICEFX CRYOABLATION SYSTEM MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24004878 ↗
• MalfunctionSep 29, 2025Gas/Air Leak; Adverse Event Without Identified Device or Use Problem; Gas/Air Leak; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PROCEDURE WAS CANCELLED DUE TO A GAS LEAK. A ICEFX CRYOABLATION SYSTEM WAS CHOSEN TO TREAT ENDOMETRIOSIS. GENERAL ANESTHESIA WAS ADMINISTERED. AN ICEROD CX 90 DEGREE NEEDLE/VL PASSED TESTING CORRECTLY AND WAS INSERTED INTO THE PATIENT FOR TREATMENT. HOWEVER, DURING THE FINAL CHECK BEFORE THE START OF THE PROCEDURE, A GAS LEAK WAS OBSERVED AT THE BACK OF THE CONSOLE AT THE LEVEL OF THE GAS OUTLET. THE SYSTEM WAS SHUT DOWN AND RESTARTED THREE TIMES; HOWEVER, THE ISSUE DID NOT RESOLVE. THE PROCEDURE WAS CANCELLED AS A RESULT OF THE GAS LEAK. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23173348 ↗
• MalfunctionFeb 24, 2025Insufficient Cooling; Device Displays Incorrect Message; Insufficient Cooling; Device Displays Incorrect Message

  IT WAS REPORTED INSUFFICIENT ICE OCCURRED. AN ICEFX CRYOABLATION SYSTEM WAS CHOSEN TO COMPLETE A LEFT RENAL CRYOABLATION. THE SYSTEM WAS TURNED ON AND ONE ICEFORCE 2.1 CX 90 DEGREE NEEDLE TESTED WITHOUT ANY ERRORS. THE PHYSICIAN INSERTED THE ICEFORCE 2.1 CX 90 DEGREE NEEDLE INTO A SATISFACTORY POSITION AND BEGAN THE FREEZE CYCLE. ANOTHER NON-PHYSICIAN HEALTHCARE PROVIDER NOTED THERE WAS AN ABSENCE OF ICE FORMATION ON THE ICEFORCE 2.1 CX 90 DEGREE NEEDLE, BUT NO ERROR MESSAGES OCCURRED. AT THE END OF THE FIRST FREEZE CYCLE, DURING THE PASSIVE THAW CYCLE, THE "80-30" ERROR MESSAGE DISPLAYED AND THE ICEFX CRYOABLATION SYSTEM WAS UNABLE TO FREEZE AS EXPECTED. TROUBLESHOOTING STEPS WERE TAKEN, SUCH AS THE ICEFORCE 2.1 CX 90 DEGREE NEEDLE WAS CHANGED TO ANOTHER CHANNEL ON THE ICEFX CRYOABLATION SYSTEM; HOWEVER, THIS DID NOT RESOLVE THE ISSUE. THE GAS WAS TURNED OFF AND THE ICEFX CRYOABLATION SYSTEM WAS VENTED. THEN, THE GAS WAS TURNED BACK ON, AND THE ERROR PERSISTED. THE PHYSICIAN DECIDED TO PROCEED WITH THE SECOND FREEZE, AND IMAGING SHOWED AN ICEBALL FORMING THAT WAS OF EXPECTED SIZE FOR THE ICEFORCE 2.1 CX 90 DEGREE NEEDLE. PASSIVE THAW WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21454126 ↗
• MalfunctionSep 24, 2024Insufficient Cooling; Insufficient Heating; Mechanical Problem; Adverse Event Without Identified Device or Use Problem; Insufficient Cooling; Insufficient Heating; Mechanical Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT INSUFFICIENT ICE OCCURRED. AN ICEFX CRYOABLATION SYSTEM WAS REPORTED TO HAVE A 40-08 ITHAW ERROR IN THE PAST. ADDITIONALLY, THE CONSOLE WAS NOT FORMING LARGE ENOUGH ICE BALLS ON THE NEEDLES CONNECTED TO CHANNELS 2A AND 2B. USING CT IMAGING IN THE MOST RECENT CASE WITH THIS CONSOLE, IT WAS OBSERVED THAT INSUFFICIENT ICE OCCURRED ON THE NEEDLES IN CHANNELS 2A AND 2B AFTER 7 MINUTES OF OPERATING TIME. THE NEEDLES WERE SWITCHED TO DIFFERENT CHANNELS TO RESOLVE THE ISSUE, AND NO PATIENT COMPLICATIONS WERE REPORTED. THE CONSOLE IS NOT BEING USED UNTIL THE ISSUE IS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20296553 ↗
• MalfunctionAug 15, 2024Insufficient Cooling; Insufficient Cooling

  IT WAS REPORTED THAT INSUFFICIENT ICE OCCURRED. AN ICEFX CRYOABLATION SYSTEM WAS SELECTED FOR A CRYOABLATION PROCEDURE. DURING THE PROCEDURE, HOWEVER, NO ICE BALL COULD BE VISUALIZED ON CT IMAGING FROM 3 OF 4 NEEDLES. THE INSUFFICIENT ICE WAS OBSERVED 8 MINUTES INTO THE FIRST FREEZE CYCLE AND 6 MINUTES INTO THE 2ND FREEZE CYCLE. A THIRD FREEZE CYCLE WAS ALSO ATTEMPTED DURING WHICH CT SCAN/US SHOWED NO ICE BALL. THE NEEDLES COULD BE REMOVED EASILY FROM THE PATIENT WITHOUT ACTIVE THAW. THE CRYOABLATION TREATMENT WAS NOT COMPLETED. MICROWAVE ABLATION WAS USED TO TREAT THE PATIENT ON THE SAME DAY. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19991841 ↗
• MalfunctionApr 11, 2024Insufficient Cooling; Insufficient Heating; Temperature Problem; Insufficient Cooling; Insufficient Heating; Temperature Problem

  IT WAS REPORTED THAT INSUFFICIENT ICE OCCURRED. AN ICEFX CRYOABLATION SYSTEM WAS SELECTED FOR A CRYOABLATION PROCEDURE OF A KIDNEY. THE FIRST FREEZE WAS COMPLETED; HOWEVER, DURING THE SECOND FREEZE, THE PROBES DID NOT FROST OVER, AND THE UNIT DID NOT SOUND LIKE IT WAS SENDING GAS THROUGH TO THE PROBES. THE TEMP DISPLAYS RANGED -100 TO -30, BUT NO ERRORS WERE SEEN. ALL THE PROBES WERE STOPPED, AND THE PROBE THAT WAS READING THE LOWEST TEMPERATURE WAS UNLOCKED AND RELOCKED. THIS CAUSED AN ITHAW/CAUTERY MALFUNCTION TO DISPLAY. ALL THE PROBES WERE STARTED AGAIN, AND ALL BUT ONE FORMED FROST. A SHUTDOWN/RESTART WAS PERFORMED, AND THE UNIT AGAIN FUNCTIONED PROPERLY. THE PROCEDURE WAS COMPLETED WITH THIS CONSOLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19092814 ↗
• MalfunctionSep 1, 2023No Display/Image; No Display/Image

  IT WAS REPORTED THAT THE SCREEN ON THE CONSOLE WOULD NOT WORK, AND THE PROCEDURE WAS CANCELLED. AN ICEFX CRYOABLATION SYSTEM WAS SELECTED FOR A LUNG CRYOABLATION PROCEDURE. DURING PREPARATION, HOWEVER, THE TOUCH SCREEN ON THE CONSOLE WOULD NOT WORK. THE MACHINE WAS SWITCHED ON AND GAS ATTACHED. THE OPENING SCREEN WHERE PASSWORD INPUT WAS DISPLAYED, BUT NO INFORMATION COULD BE ENTERED AS THE TOUCH SCREEN WOULD NOT RESPOND. THE CONSOLE WAS SWITCHED OFF AND ON AGAIN, BUT THERE WAS STILL NO TOUCH SCREEN RESPONSE. IT WAS ATTEMPTED TO DO A ROLLBACK AS WELL, BUT THE ROLLBACK OPTION COULD NOT BE SELECTED ON THE TOUCHSCREEN. THE PATIENT HAD ALREADY BEEN SEDATED UNDER GENERAL ANESTHESIA, BUT THE PROCEDURE WAS CANCELLED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17670265 ↗
• MalfunctionMay 6, 2022Temperature Problem; Temperature Problem

  IT WAS REPORTED THAT THERE WAS A TEST FAILURE. A ICEFX CRYOABLATION SYSTEM CONSOLE WAS SELECTED FOR USE FOR THIS LUNG TUMOR CRYOABLATION. DURING THE PROCEDURE, THERE WAS A TEST FAILURE ON THE CONSOLE AND THE PROCEDURE WAS NOT ABLE TO BE COMPLETED. TROUBLESHOOTING PERFORMED BY THE FIELD REPRESENTATIVE ON THE ICEFX CONSOLE WITH A DEMO ICEROD NEEDLE SHOWED THE NEEDLE PASSED PRE-PROCEDURE TESTING, BUT THE TEMPERATURE NEVER DROPPED BELOW -90 CELSIUS (EXPECTED TO DROP TO -140 CELSIUS). THE SYSTEM WAS FLUSHED WITH LOW PRESSURE ARGON GAS FOR TEN MINUTES, HOWEVER, THAT DID NOT RESOLVE THE REPORTED ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14311901 ↗
• MalfunctionMay 5, 2022Defective Device; Defective Device

  IT WAS REPORTED THAT THE PROCEDURE WAS ABORTED. AN ICEFX CRYOABLATION SYSTEM CONSOLE WAS SELECTED FOR USE FOR THIS LUNG TUMOR CRYOABLATION. DURING THE PROCEDURE, THERE WAS A TEST FAILURE ON THE CONSOLE AND THE PROCEDURE WAS NOT ABLE TO BE COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14291030 ↗
• MalfunctionMay 5, 2022Insufficient Cooling; Temperature Problem; Insufficient Cooling; Temperature Problem

  IT WAS REPORTED THAT THERE WAS INSUFFICIENT ICE. AN ICEFX CRYOABLATION SYSTEM WAS SELECTED FOR LUNG TUMOR CRYOABLATION WITH TWO ICEROD CX 90 DEGREE NEEDLES. THE NEEDLES PASSED PRE-PROCEDURE TESTING PRIOR TO USE. DURING THE PROCEDURE, THE PHYSICIAN NOTED THAT THE ICE BALL FORMED ON THE NEEDLES WAS NOT SHAPED AS USUAL. THE ICE FORMATION WAS NOTED TO BE SUBOPTIMAL. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. TROUBLESHOOTING PERFORMED BY THE FIELD REPRESENTATIVE ON THE ICEFX CONSOLE WITH A DEMO ICEROD NEEDLE SHOWED THE NEEDLE PASSED PRE-PROCEDURE TESTING, BUT THE TEMPERATURE NEVER DROPPED BELOW -90 CELSIUS (EXPECTED TO DROP TO -140 CELSIUS). THE SYSTEM WAS FLUSHED WITH LOW PRESSURE ARGON GAS FOR TEN MINUTES, HOWEVER, THAT DID NOT RESOLVE THE REPORTED ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14290932 ↗
• MalfunctionMay 5, 2022Insufficient Cooling; Temperature Problem; Insufficient Cooling; Temperature Problem

  IT WAS REPORTED THAT THERE WAS INSUFFICIENT ICE. AN ICEFX CRYOABLATION SYSTEM WAS SELECTED FOR LUNG TUMOR CRYOABLATION WITH TWO ICEROD CX 90 DEGREE NEEDLES. THE NEEDLES PASSED PRE-PROCEDURE TESTING PRIOR TO USE. DURING THE PROCEDURE, THE PHYSICIAN NOTED THAT THE ICE BALL FORMED ON THE NEEDLES WAS NOT SHAPED AS USUAL. THE ICE FORMATION WAS NOTED TO BE SUBOPTIMAL. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. TROUBLESHOOTING PERFORMED BY THE FIELD REPRESENTATIVE ON THE ICEFX CONSOLE WITH A DEMO ICEROD NEEDLE SHOWED THE NEEDLE PASSED PRE-PROCEDURE TESTING, BUT THE TEMPERATURE NEVER DROPPED BELOW -90 CELSIUS (EXPECTED TO DROP TO -140 CELSIUS). THE SYSTEM WAS FLUSHED WITH LOW PRESSURE ARGON GAS FOR TEN MINUTES, HOWEVER, THAT DID NOT RESOLVE THE REPORTED ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14287889 ↗
• MalfunctionMay 5, 2022Insufficient Cooling; Temperature Problem; Insufficient Cooling; Temperature Problem

  IT WAS REPORTED THAT THERE WAS INSUFFICIENT ICE. AN ICEFX CRYOABLATION SYSTEM WAS SELECTED FOR LUNG TUMOR CRYOABLATION WITH TWO ICEROD CX 90 DEGREE NEEDLES. THE NEEDLES PASSED PRE-PROCEDURE TESTING PRIOR TO USE. DURING THE PROCEDURE, THE PHYSICIAN NOTED THAT THE ICE BALL FORMED ON THE NEEDLES WAS NOT SHAPED AS USUAL. THE ICE FORMATION WAS NOTED TO BE SUBOPTIMAL. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14287878 ↗
• MalfunctionApr 26, 2022Defective Device; Output Problem; Defective Device; Output Problem

  IT WAS REPORTED THAT AN INABILITY TO DEACTIVATE THAWING FUNCTION OCCURRED. AN ICEFX CRYOABLATION SYSTEM WAS SELECTED FOR USE. THE FIRST FREEZE CYCLE WAS ACTIVATED AND PASSIVE HEATING PERFORMED WITH NO PROBLEMS ACROSS ALL PORTS. A SECOND FREEZE CYCLE WAS PERFORMED WITH NO PROBLEMS. DURING THE FINAL HEATING PHASE, THERE WERE NO PROBLEMS WITH PASSIVE THAW; HOWEVER, WHEN ACTIVELY INITIATING THE HEATING, TWO PORTS FAILED SIMULTANEOUSLY. ONCE I-THAW WAS STARTED ON THE REST OF THE NEEDLES, THAWING COULD NOT BE STOPPED. THE PAUSE-STOP BUTTON WAS BLOCKED. THE PHYSICIAN QUICKLY INITIATED THE FREEZE OPTION ON ALL NEEDLES AND STOP THEM AGAIN RIGHT AWAY. PASSIVE THAW WAS USED AND THE NEEDLES WERE REMOVED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14212129 ↗
• MalfunctionApr 26, 2022Mechanical Problem; Defective Device; Mechanical Problem; Defective Device

  IT WAS REPORTED THAT AN INABILITY TO DEACTIVATE THAWING FUNCTION OCCURRED. AN ICEFX CRYOABLATION SYSTEM WAS SELECTED FOR USE. THE FIRST FREEZE CYCLE WAS ACTIVATED AND PASSIVE HEATING PERFORMED WITH NO PROBLEMS ACROSS ALL PORTS. A SECOND FREEZE CYCLE WAS PERFORMED WITH NO PROBLEMS. DURING THE FINAL HEATING PHASE, THERE WERE NO PROBLEMS WITH PASSIVE THAW; HOWEVER, WHEN ACTIVELY INITIATING THE HEATING, PORT 3 FAILED. ONCE I-THAW WAS STARTED ON THE REST OF THE NEEDLES, THAWING COULD NOT BE STOPPED. THE PAUSE-STOP BUTTON WAS BLOCKED. THE PHYSICIAN QUICKLY INITIATED THE FREEZE OPTION ON ALL NEEDLES AND STOP THEM AGAIN RIGHT AWAY. PASSIVE THAW WAS USED AND THE NEEDLES WERE REMOVED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14212063 ↗
• MalfunctionDec 20, 2021Device Alarm System; Temperature Problem; Device Alarm System; Temperature Problem

  IT WAS REPORTED THAT ERROR CODES RESULTED IN AN UNSUCCESSFUL ABLATION. A ICEFX CRYOABLATION SYSTEM WAS SELECTED FOR USE IN A RENAL MASS ABLATION PROCEDURE. DURING THE PROCEDURE, THEY WERE UNABLE TO FINISH THE FREEZE DUE AN ERROR CODE 80-30 RELATED TO INTERNAL PRESSURE CHECKS. AN ADDITIONAL ERROR CODE 40-08 WAS ALSO OBSERVED RELATED TO AUTOMATIC STOP OF ELECTRICAL THAWING ON ALL SYSTEM CHANNELS. THESE ERROR CODES OCCURRED OUTSIDE OF THE PATIENT, HOWEVER RESULTED IN AN UNSUCCESSFUL ABLATION PROCEDURE FOR THIS PATIENT. PRODUCT MAINTENANCE WAS PERFORMED ON THE DEVICE A WEEK AFTER THIS PROCEDURE, WHERE THE PROBES WERE REPLACED AND THE DEVICE APPEARS TO BE WORKING AS EXPECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13043530 ↗
• InjurySep 1, 2020Defective Device; Defective Device

  IT WAS REPORTED THAT A PATIENT WAS UNDERTREATED AFTER CRYOABLATION WITH A VISUAL-ICE SYSTEM. A PATIENT UNDERWENT CRYOABLATION FOR RENAL CELL CARCINOMA ON (B)(6) 2020. ONE ICEFORCE CRYOABLATION NEEDLE WAS USED. NO REPORTED ISSUES OCCURRED DURING THE PROCEDURE AND THE ICEBALL SIZE WAS CONFIRMED TO ADEQUATELY COVER THE LESION. DURING FOLLOW UP (DATE UNKNOWN), IT WAS IDENTIFIED THAT THE LESION WAS UNDERTREATED AND THE PATIENT UNDERWENT ADDITIONAL CRYOABLATION FOR RE-TREATMENT. IT WAS FURTHER REPORTED THAT THE MOST RECENT POST-PROCEDURE SCAN STILL SHOWS RESIDUAL TUMOR. THE PHYSICIAN REPORTED THAT THE SYSTEM IS NOT CREATING SUFFICIENT ICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Code Available; Therapeutic Effects, Unexpected

  MAUDE report 10476260 ↗
• InjuryDec 20, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SYSTEM AND 2 ICEFORCE CX NEEDLES TESTED WITH NO ISSUES TO REPORT. THE CASE WAS COMPLETED AND THE TREATING PHYSICIAN WAS SATISFIED. NINE DAYS POST-PROCEDURE, THE PATIENT REPORTED PAIN AND NUMBNESS IN HER HIP. DURING FOLLOW-UP, THE PHYSICIAN INFORMED THAT THE PATIENT EXPERIENCED SIGNIFICANT PAIN WHICH WAS MOST LIKELY DUE TO INJURY TO THE GENITOFEMORAL NERVE, WHICH TRACKS ALONG THE PSOAS MUSCLE. THE PATIENT WAS STARTED ON NEURONTIN, WHICH SHE COULD NOT TOLERATE DUE TO SUPPOSED FACIAL SWELLING. THE PHYSICIAN SWITCHED TO LYRICA WHICH SHE IS CURRENTLY TOLERATING. THE PATIENT INFORMED THE PHYSICIAN THAT THE PAIN HAS NOT SUBSIDED. THERE WERE NO DEVICE MALFUNCTION REPORTED AT THE TIME OF THE CRYOABLATION PROCEDURE.

  Patient problems: Nerve Damage; Numbness; Pain

  MAUDE report 8187241 ↗