IceSphere™ 1.5 CX Cryoablation Needle FPRPR3573Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 07290104831133), received between Mar 20, 2019 and Sep 16, 2025 — classified as 9 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Thermal Decomposition of Device” (10 reports).

1 FDA recall record name this device's identifier.

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. Nov 18, 2020Class IICompleted

   Complaint trend regarding needle shaft gas leaks.

   Z-0664-2021 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 28 reports, in the reporter's own words as published by the FDA.

• InjurySep 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A SKIN BURN. THREE ICESPHERE 1.5 CX 90 DEGREE NEEDLES WERE CHOSEN FOR A GENICULATE NERVE CRYOABLATION PROCEDURE. THE TREATMENT WAS COMPLETED AND ALL THREE ICESPHERE 1.5 CX 90 DEGREE NEEDLES FUNCTIONED AS EXPECTED. DURING FOLLOW-UP, A BURN OF AN UNKNOWN DEGREE WAS DISCOVERED ON THE PATIENT'S SKIN. THE PHYSICIAN TREATED THE SKIN BURN WITH HEALING OINTMENT AND AN ORAL MEDICINE. THE PATIENT IS EXPECTED TO FULL RECOVER WITHOUT PERMANENT IMPAIRMENT.

  Patient problems: Burn(s)

  MAUDE report 23067408 ↗
• InjurySep 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A SKIN BURN. THREE ICESPHERE 1.5 CX 90 DEGREE NEEDLES WERE CHOSEN FOR A GENICULATE NERVE CRYOABLATION PROCEDURE. THE TREATMENT WAS COMPLETED AND ALL THREE ICESPHERE 1.5 CX 90 DEGREE NEEDLES FUNCTIONED AS EXPECTED. DURING FOLLOW-UP, A BURN OF AN UNKNOWN DEGREE WAS DISCOVERED ON THE PATIENT'S SKIN. THE PHYSICIAN TREATED THE SKIN BURN WITH HEALING OINTMENT AND AN ORAL MEDICINE. THE PATIENT IS EXPECTED TO FULL RECOVER WITHOUT PERMANENT IMPAIRMENT.

  Patient problems: Burn(s)

  MAUDE report 23067405 ↗
• InjurySep 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A SKIN BURN. THREE ICESPHERE 1.5 CX 90 DEGREE NEEDLES WERE CHOSEN FOR A GENICULATE NERVE CRYOABLATION PROCEDURE. THE TREATMENT WAS COMPLETED AND ALL THREE ICESPHERE 1.5 CX 90 DEGREE NEEDLES FUNCTIONED AS EXPECTED. DURING FOLLOW-UP, A BURN OF AN UNKNOWN DEGREE WAS DISCOVERED ON THE PATIENT'S SKIN. THE PHYSICIAN TREATED THE SKIN BURN WITH HEALING OINTMENT AND AN ORAL MEDICINE. THE PATIENT IS EXPECTED TO FULL RECOVER WITHOUT PERMANENT IMPAIRMENT.

  Patient problems: Burn(s)

  MAUDE report 23067398 ↗
• InjuryJan 16, 2025Thermal Decomposition of Device; Insufficient Heating; Thermal Decomposition of Device; Insufficient Heating

  IT WAS REPORTED THAT FROST FORMED ON THE DEVICE AND THE PATIENT EXPERIENCED A SKIN BURN. THE PATIENT WAS BEING TREATED FOR A BREAST TUMOR. THE ICEFX CRYOABLATION SYSTEM AND AN ICESPHERE 1.5 CX 90 DEGREE NEEDLE WERE FOR SELECTED USE. INITIALLY, THE I-THAW MODE WAS NOT WORKING ON ANY PORT. AFTER TROUBLESHOOTING, THE ISSUE WAS RESOLVED, BUT THEN AFTER 5 MINUTES OF FREEZING, THE ISSUE OCCURRED AGAIN. THE FAULT CODES 80-30 AND 40-08 WERE RECEIVED. THE USER PRESSED THE PAUSE BUTTON; HOWEVER, THE NEEDLE KEPT FREEZING AND THE ICEBALL CONTINUED TO GROW. THEY WAITED A FEW MINUTES WITH NO CHANGES TO THE SYSTEM. FROST WAS OBSERVED ON THE DEVICE AND A BURN WAS OBSERVED ON THE SKIN OF THE PATIENT. THE ARGON GAS WAS SHUT OFF. THE NEEDLE WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED. THE BURN WAS TREATED WITH SILVER SULFADIAZINE CREAM. THE PATIENT WAS REPORTED TO BE OK AND THERE WERE NO FURTHER COMPLICATIONS.

  Patient problems: Full thickness (Third Degree) Burn

  MAUDE report 21174372 ↗
• MalfunctionOct 17, 2024Thermal Decomposition of Device; Thermal Decomposition of Device

  IT WAS REPORTED THAT FROST WAS OBSERVED ON THE NEEDLE SHAFT. THIS ICESPHERE 1.5 CX 90 DEGREE NEEDLE WAS ONE OF A FEW NEEDLES SELECTED FOR INTERCOSTAL NERVE CRYOABLATION FOR PAIN MANAGEMENT. DURING THE PROCEDURE, THE NEEDLE WAS PLACED INTO CHANNEL 4B AND THE TEST WAS SUCCESSFUL. THE PHYSICIAN INSERTED PROBE AND ONCE PLACED AS DESIRED, BEGAN FIRST FREEZE. CLOSE TO THE 10 MINUTE MARK, THE PHYSICIAN NOTICED THE PROBE WAS FROSTING OVER ALONG THE NEEDLE CLOSE TO THE SKIN SO A SYRINGE WAS USED TO APPLY WARM SALINE. ON THE NEXT FREEZE CYCLE, THE PROBE WAS FROSTING UP AGAIN, THIS TIME MORE RAPIDLY AND CLOSER TO THE SKIN. THE PATIENT'S SKIN BECAME PINK/RED AND CT IMAGING SHOWED SUBCUTANEOUS IRRITATION. THE NEEDLE WAS REMOVED AND THE CASE WAS COMPLETED SUCCESSFULLY WITH A NEW NEEDLE. IT WAS REPORTED THAT THERE WERE NO PATIENT COMPLICATIONS. ADDITIONAL INFORMATION CONFIRMED THE RETURNED NEEDLE (LOT 0034129154) WAS THE CORRECT LOT FOR THE REPORTED ISSUE.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 20471972 ↗
• InjuryMay 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT EXPERIENCED TACHYCARDIA REQUIRING RESUSCITATION. AN ICESPHERE 1.5 CX 90 DEGREE NEEDLE WAS CHOSEN FOR A GANGLION IMPAR CRYONEUROLYSIS PROCEDURE. THE PATIENT WAS PRONE ON THE COMPUTED TOMOGRAPHY (CT) TABLE UNDER MODERATE SEDATION. THE ICESPHERE NEEDLE WAS INSERTED INTO THE GANGLION IMPAR AREA. THE ANESTHESIOLOGIST ADMINISTERED ADDITIONAL PAIN MEDICATIONS PRIOR TO STARTING THE FREEZE CYCLE. THE PATIENT BECAME IMMEDIATELY TACHYCARDIC. THE CODE TEAM WAS CALLED IN AND THE PATIENT WAS RESUSCITATED. THE PROCEDURE WAS CANCELLED. THE PATIENT IS CURRENTLY IN THE INTENSIVE CARE UNIT (ICU).

  Patient problems: Tachycardia

  MAUDE report 19429418 ↗
• MalfunctionNov 17, 2023Thermal Decomposition of Device; Thermal Decomposition of Device

  IT WAS REPORTED THAT FROST FORMED ON THE NEEDLE SHAFT. AN ICESPHERE 1.5 CX 90 DEGREE NEEDLE WAS SELECTED FOR A CRYOABLATION PROCEDURE TO TREAT A SOFT TISSUE MASS IN THE LUNG. DURING THE PROCEDURE, HOWEVER, FROST WAS FORMING ON THE NEEDLE SHAFT. TO PREVENT FROSTBITE, THE NEEDLE WAS REPLACED WITH ANOTHER NEEDLE OF THE SAME MODEL. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18160745 ↗
• MalfunctionNov 15, 2023Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT A NEEDLE SHAFT LEAK OCCURRED. AN ICESPHERE 1.5 CX 90 DEGREE NEEDLE WAS SELECTED FOR A CRYOABLATION PROCEDURE TO TREAT A DESMOID TUMOR. DURING THE TEST PHASE, HOWEVER, THERE WERE BUBBLES SEEN COMING FROM THE NEEDLE SHAFT WHILE IT WAS FULLY SUBMERGED IN THE SALINE BATH. THERE WAS NO VISIBLE DAMAGE SEEN. THE NEEDLE WAS EXCHANGED ANOTHER OF THE SAME MODEL. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE NEW NEEDLE AND THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18144846 ↗
• MalfunctionNov 14, 2023Contamination; Contamination

  IT WAS REPORTED THAT THE DEVICE BECAME CONTAMINATED DURING PREPARATION. AN ICESPHERE 1.5 CX 90 DEGREE NEEDLE WAS SELECTED FOR A CRYOABLATION PROCEDURE IN THE LIVER. WHILE TRYING TO FLUSH THE NEEDLE, THE PRODUCT WAS CONTAMINATED. THE NEEDLE WAS EXCHANGED FOR ANOTHER OF THE SAME MODEL TO COMPLETE THE PROCEDURE, AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18133050 ↗
• MalfunctionDec 16, 2022Thermal Decomposition of Device; Thermal Decomposition of Device

  IT WAS REPORTED THAT THERE WAS FROST OBSERVED ON THE NEEDLE SHAFT. THIS ICESPHERE 1.5 CX 90-DEGREE WAS SELECTED FOR A CRYOABLATION PROCEDURE TO TREAT A TUMOR. DURING THE PROCEDURE, THIS NEEDLE HAD FROST DEVELOP ALONG THE SHAFT OF THE NEEDLE. THE NEEDLE WAS ABLE TO BE USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THE FROST DID NOT REACH DOWN WHERE THE NEEDLE ENTERED THE SKIN OF THE PATIENT; NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15996539 ↗
• MalfunctionOct 10, 2022Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT A LEAK FROM THE NEEDLE SHAFT OCCURRED. AN ICESPHERE 1.5 CX 90 DEGREE NEEDLE WAS SELECTED FOR TREATMENT IN THE LUNG. DURING TESTING, GAS/AIR WAS LEAKING FROM THE NEEDLE SHAFT. TROUBLESHOOTING WAS PERFORMED BY TRYING ANOTHER CHANNEL. ANOTHER ICESPHERE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15571699 ↗
• MalfunctionSep 1, 2022Gas/Air Leak; Gas/Air Leak

  A SHAFT GAS LEAK WAS REPORTED. A 1.5 CX 90 DEGREE ICEPHERE NEEDLE WAS SELECTED FOR USE IN A RENAL CRYOABLATION PROCEDURE. DURING DEVICE INTEGRITY TESTING, PRIOR TO INSERTION INTO THE PATIENT, THE NEEDLE WAS SUBMERGED IN A TESTING BOWL AND BUBBLES OCCURRED ALONG THE SHAFT OF THE NEEDLE AT THE PROXIMAL END NEAR THE SHAFT TO HANDLE JOINT, BUT NOT AT THE JOINT. THE NEEDLE WAS EXCHANGED AND THE PROCEDURE WAS COMPLETED WITH NO REPORTED PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15335922 ↗
• MalfunctionAug 24, 2022Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THE NEEDLE GAS LEAK OCCURRED. DURING PREPARATION FOR A RENAL CELL CARCINOMA (RCC) TREATMENT PROCEDURE, INTEGRITY TESTING OF AN ICESPHERE 1.5 CX 90 DEGREE CRYOABLATION NEEDLE REVEALED A GAS LEAK AT AN UNKNOWN LOCATION. THE NEEDLE WAS EXCHANGED AND THE PROCEDURE WAS COMPLETED WITH NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15289012 ↗
• MalfunctionFeb 1, 2022Thermal Decomposition of Device; Thermal Decomposition of Device

  IT WAS REPORTED FROST ON THE SHAFT OF THE NEEDLE OCCURRED. DURING TREATMENT OF A FIBROUS DYSPLASIA MASS OF THE FEMUR, TWO ICESPHERE 1.5 CX 90 DEGREE CRYOABLATION NEEDLES WERE USED. ICE WAS SEEN ON THE NEEDLE SHAFT OF ONE OF THE ICESPHERE NEEDLES. THE PATIENT SKIN WAS PROTECTED DURING THE CASE TO PREVENT SKIN ULCERATION. THE PROCEDURE WAS COMPLETED WITHOUT PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13417139 ↗
• MalfunctionAug 30, 2021Gas/Air Leak; Gas/Air Leak

  THE PROCEDURE WAS RELATED TO THE ABSCOPAL EFFECT CLINICAL STUDY. IT WAS REPORTED THAT THERE WAS A GAS/AIR LEAK FROM THE NEEDLE SHAFT. AN ICESPHERE 1.5 CX 90 DEGREE CRYOABLATION NEEDLE WAS SELECTED FOR A CANCER TREATMENT CRYOABLATION PROCEDURE. WHEN THE NEEDLE WAS REMOVED FROM PACKAGING FOR TESTING, A DARKENED SPOT ON THE NEEDLE COVER WAS OBSERVED. WHEN THE DEVICE WAS TESTED, AND THE GAS PHASE HIT, THE NEEDLE IMMEDIATELY STARTED BUBBLING; A GAS/AIR LEAK WAS NOTED AT THE NEEDLE SHAFT. IT SEEMED TO LINE UP WITH WHERE THE DARKENED MARK WAS ON THE COVER. THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12387952 ↗
• MalfunctionJul 14, 2021Thermal Decomposition of Device; Thermal Decomposition of Device

  IT WAS REPORTED THAT FROST ON THE SHAFT WAS OBSERVED. DURING A LUNG CRYOABLATION PROCEDURE USING TWO ICESPHERE 1.5 CX 90 DEGREE NEEDLES, FROST WAS OBSERVED ON THE ENTIRE SHAFT OF ONE OF THE NEEDLES AND WAS ADHERED TO THE PATIENT'S SKIN. THE TREATMENT WAS COMPLETED SUCCESSFULLY USING BOTH ORIGINAL DEVICES WITH NO INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12169697 ↗
• MalfunctionDec 11, 2020Thermal Decomposition of Device; Thermal Decomposition of Device

  IT WAS REPORTED THERE WAS FROST ON THE NEEDLE SHAFT. A CRYOABLATION TREATMENT PROCEDURE WAS PERFORMED USING AN ICESPHERE 1.5 CX 90 DEGREE CRYOABLATION NEEDLE. BEFORE INSERTION INTO THE PATIENT, THE NEEDLES WERE TESTED AND PASSED. A MINUTE OR TWO AFTER STARTING THE FREEZE CYCLE THE NEEDLE INSULATION DID NOT WORK. THE PHYSICIAN PROTECTED THE PATIENT'S SKIN WITH GAUZE AND CONTINUOUS IRRIGATION. NO PATIENT INJURY WAS REPORTED AND THE ABLATION ZONE INDICATED A LIKELIHOOD OF A SUCCESSFUL OUTCOME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10992596 ↗
• MalfunctionNov 9, 2020Thermal Decomposition of Device; Thermal Decomposition of Device

  IT WAS REPORTED THE NEEDLE SHAFT FROZE AND A SKIN BURN OCCURRED. DURING A RENAL CRYOABLATION PROCEDURE AN ICESPHERE 1.5 CX 90 DEGREE NEEDLES WAS USED. DURING FREEZING THE NEEDLE SHAFT FROZE AND REQUIRED HOT PHYSIOLOGICAL SERUM TO BE USED TO AVOID ANY FURTHER SUPERFICIAL BURNS. A NEW NEEDLE WAS USED TO COMPLETE THE CASE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Burn(s)

  MAUDE report 10812138 ↗
• MalfunctionJun 27, 2020Thermal Decomposition of Device; Thermal Decomposition of Device

  IT WAS REPORTED THAT AN ICESPHERE NEEDLE HAD FROST ON THE SHAFT DURING THE FIRST FREEZE CYCLE OF A RENAL CRYOABLATION PROCEDURE. THE PHYSICIAN STOPPED THE PROCEDURE AND REPLACED THE NEEDLE WITH ANOTHER ICESPHERE. THE CASE WAS COMPLETED WITHOUT ANY PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10204303 ↗
• MalfunctionJun 18, 2020Thermal Decomposition of Device; Thermal Decomposition of Device

  IT WAS REPORTED THAT DURING A HEPATIC CRYOABLATION PROCEDURE, AN ICESPHERE NEEDLE CREATED FROST DOWN THE SHAFT, POSSIBLY CONTACTING THE PATIENT'S SKIN. TWO TEN MINUTE FREEZE CYCLES WERE COMPLETED PRIOR, BUT THE PHYSICIAN WAS NOT SATISFIED WITH THE ATTAINED MARGIN. THE PHYSICIAN DECIDED TO REPOSITION THE FIRST NEEDLE AND ADD A SECOND TO OBTAIN LARGER ICE. THE FROST WAS NOTICED BY THE DOCTOR AT THE END OF THE THIRD FREEZE CYCLE. THEY DRIPPED STERILE SALINE AT THE INSERTION SITE AND HALTED THE FREEZE CYCLE. STERILE SALINE WAS THEN CONTINUOUSLY DRIPPED ONTO THE NEEDLE SHAFT DURING FREEZE. THE PHYSICIAN WAS SATISFIED AT THE ATTAINED MARGIN USING THE TWO NEEDLES. NO PATIENT IMPACT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10168684 ↗
• MalfunctionMar 26, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THIS MDR IS TO DOCUMENT THE MANUFACTURER'S INVESTIGATION OF THE NEEDLE USED IN THE REPORTED EVENT. FURTHER INVESTIGATION OR FOLLOW-UP IS NOT PLANNED FOR THIS COMPLAINT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9884044 ↗
• MalfunctionMar 26, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THIS MDR IS TO DOCUMENT THE MANUFACTURER'S INVESTIGATION OF THE NEEDLE USED IN THE REPORTED EVENT. FURTHER INVESTIGATION OR FOLLOW-UP IS NOT PLANNED FOR THIS COMPLAINT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9884043 ↗
• MalfunctionFeb 29, 2020Failure to Fire; Failure to Fire

  ONE ICEPEARL CX CRYOABLATION NEEDLE WAS USED FOR A LEFT RENAL LESION (1.2CM MASS). AN ADDITIONAL ICESPHERE CX NEEDLE WAS INTRODUCED IN THE THIRD FREEZE CYCLE OF THE PROCEDURE. BOTH NEEDLES PASSED TESTING, WITH NO LEAKS, A UNIFORM ICEBALL, WITH CORRECT FORMATION FOLLOWED BY PROPER THAWING. NO ERROR MESSAGE OCCURED DURING THE NEEDLE TEST. A BIOPSY WAS PERFORMED PRIOR TO FREEZING, AND THE NEEDLE POSITIONING WAS CONFIRMED WITH CT WITH NO CRITICAL STRUCTURES WERE OBSERVED NEAR THE PLANNED ABLATION ZONE. THE ICEBALL WAS NOT VISIBLE THROUGHOUT THE PROCEDURE. NO FLUCTUATION IN NEEDLE TEMPERATURE, FREEZING PERCENTAGE AND GAS PRESSURE WAS OBSERVED THROUGHOUT THE ENTIRE PROCEDURE. CONTRAST WAS PRODUCED IN THE FOURTH CYCLE, BUT NO ICEBALL WAS VISIBLE. THE USER SPECIFICALLY NOTED THAT ICE WAS NOT VISIBLE AT THE FOLLOWING TIMEPOINTS: FIRST FREEZE - 5 MINUTES, FIRST FREEZE - 8 MINUTES, SECOND FREEZE, THIRD FREEZE, FOURTH FREEZE. AFTER THE PROCEDURE, THE NEEDLES WERE THEN TESTED BY BEING SUBMERGED IN BASIN OF WATER, AND TESTED SUCCESSFULLY WITH ICE IMMEDIATELY FORMING. THERE WAS NO INDICATION OF A FREEZING ERROR, NEEDLE LEAK OR NEEDLE CLOG. THE NEEDLES WERE KEPT AND WILL BE RETURNED TO THE MANUFAC

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9772614 ↗
• InjuryFeb 29, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  TWO CRYOABLATION NEEDLES WERE USED TO TREAT A SCLEROTIC METASTATIC THORACIC VERTEBRAL BODY USING BIPEDICULAR ACCESS. AFTER THE PROCEDURE, A THERMAL LESION TO THE SPINAL CORD WAS DISCOVERED. THE PATIENT IS PARAPLEGIC AS A RESULT OF THE LESION. THE USER BELIEVES THE THERMAL LESION TO BE RELATED TO THE CRYOABLATION PROCEDURE. THERE WAS NO REPORTED MALFUNCTION WITH THE CRYOABLATION NEEDLES, AND THE NEEDLES WILL NOT BE RETURNED TO THE MANUFACTURER FOR INVESTIGATION. AN ANONYMISED TRANSVERSE IMAGE OF THE NEEDLE PLACEMENT WAS SENT BY THE USER TO THE MANUFACTURER TO ESTIMATE THE EXPECTED POSTERIOR LIMIT OF THE ICEBALL. THIS MDR IS BEING SUBMITTED FOR THE FIRST NEEDLE USED DURING THIS PROCEDURE. PLEASE SEE MDR # 9616793-2020-00046 FOR THE SECOND NEEDLE USED DURING THIS PROCEDURE.

  Patient problems: Paraplegia; Spinal Cord Injury

  MAUDE report 9772515 ↗
• InjuryFeb 29, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THIS MDR IS TO DOCUMENT THE FOLLOW-UP AND MEDICAL ASSESSMENT PERFORMED BY THE MANUFACTURER FOR THE THERMAL LESION OF THE SPINAL CORD THAT WAS INITIALLY REPORTED. FURTHER INVESTIGATION OR FOLLOW-UP IS NOT PLANNED FOR THIS COMPLAINT. THIS MDR IS BEING SUBMITTED FOR THE SECOND NEEDLE USED DURING THIS PROCEDURE. PLEASE SEE MDR # 9616793-2020-00045 FOR THE FIRST NEEDLE USED DURING THIS PROCEDURE.

  Patient problems: Paraplegia; Spinal Cord Injury

  MAUDE report 9772514 ↗