IceSphere® 1.5 90° Cryoablation Needle FPRPR3560Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 07290104830945), received between Jun 1, 2017 and Aug 22, 2024 — classified as 3 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (6 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-0670-2021 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryAug 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA LITERATURE THAT A VENOUS THROMBOSIS OCCURRED POST-CRYOABLATION TREATMENT, REQUIRING MEDICATION. THE CRYOABLATION WAS PERFORMED USING A VISUAL ICE CONSOLE AND TWO ICESPHERE NEEDLES UNDER LOCAL ANESTHESIA AND COMPUTED TOMOGRAPHY (CT) FLUOROSCOPY GUIDANCE. THE TWO ADJACENT RENAL CELL CARCINOMAS (RCC) WERE ABLATED SIMULTANEOUSLY IN TWO FREEZING CYCLES (10 AND 12 MIN), WITH 2 MIN OF PASSIVE THAWING IN BETWEEN. AFTER EACH CYCLE, THE OPERATOR CONFIRMED THAT THE TARGET WAS WITHIN A LOW-ATTENUATION AREA, KNOWN AS AN ICE-BALL, ON CT SCAN WITH SUFFICIENT CIRCUMFERENTIAL ABLATION MARGIN. SOME OF THE LIVER PARENCHYMA WAS INCLUDED IN THE ICE-BALL, BUT THE PROCEDURE WAS CARRIED OUT WITHOUT ANY IMMEDIATE COMPLICATIONS. ON DAY 2 POST-CRYOABLATION, CONTRAST-ENHANCED CT REVEALED A THROMBUS IN THE PORTAL VEIN IN SEGMENT 6 NEAR THE ABLATED LIVER PARENCHYMA, AND ORAL ANTICOAGULANT THERAPY (EDOXABAN, 60 MG/DAY) WAS INITIATED. THE PATIENT WAS DISCHARGED ON DAY 4 POST-CRYOABLATION WITHOUT ANY SEQUELAE, AND A FOLLOW-UP CONTRAST-ENHANCED CT PERFORMED 6 WEEKS LATER REVEALED THE RESOLUTION OF THE PORTAL VEIN THROMBUS.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 20040174 ↗
• InjuryAug 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA LITERATURE THAT A VENOUS THROMBOSIS OCCURRED POST-CRYOABLATION TREATMENT, REQUIRING MEDICATION. THE CRYOABLATION WAS PERFORMED USING A VISUAL ICE CONSOLE AND TWO ICESPHERE NEEDLES UNDER LOCAL ANESTHESIA AND COMPUTED TOMOGRAPHY (CT) FLUOROSCOPY GUIDANCE. THE TWO ADJACENT RENAL CELL CARCINOMAS (RCC) WERE ABLATED SIMULTANEOUSLY IN TWO FREEZING CYCLES (10 AND 12 MIN), WITH 2 MIN OF PASSIVE THAWING IN BETWEEN. AFTER EACH CYCLE, THE OPERATOR CONFIRMED THAT THE TARGET WAS WITHIN A LOW-ATTENUATION AREA, KNOWN AS AN ICE-BALL, ON CT SCAN WITH SUFFICIENT CIRCUMFERENTIAL ABLATION MARGIN. SOME OF THE LIVER PARENCHYMA WAS INCLUDED IN THE ICE-BALL, BUT THE PROCEDURE WAS CARRIED OUT WITHOUT ANY IMMEDIATE COMPLICATIONS. ON DAY 2 POST-CRYOABLATION, CONTRAST-ENHANCED CT REVEALED A THROMBUS IN THE PORTAL VEIN IN SEGMENT 6 NEAR THE ABLATED LIVER PARENCHYMA, AND ORAL ANTICOAGULANT THERAPY (EDOXABAN, 60 MG/DAY) WAS INITIATED. THE PATIENT WAS DISCHARGED ON DAY 4 POST-CRYOABLATION WITHOUT ANY SEQUELAE, AND A FOLLOW-UP CONTRAST-ENHANCED CT PERFORMED 6 WEEKS LATER REVEALED THE RESOLUTION OF THE PORTAL VEIN THROMBUS.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 20016280 ↗
• MalfunctionFeb 21, 2023Thermal Decomposition of Device; Thermal Decomposition of Device

  IT WAS REPORTED THAT FROST WAS OBSERVED ON THE NEEDLE SHAFT. THIS ICESPHERE 90 DEGREE NEEDLE WAS SELECTED FOR USE IN A CRYOABLATION PROCEDURE TO TREAT RENAL CELL CARCINOMA. DURING THE PROCEDURE, FROST FORMED ON THE SHAFT OF THE NEEDLE. WARM WATER WAS POURED ON THE AREA WHERE THE NEEDLE MEETS THE SKIN. THE PROCEDURE WAS CONTINUED WITHOUT SEQUALAE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16414614 ↗
• MalfunctionOct 21, 2022Thermal Decomposition of Device; Thermal Decomposition of Device

  IT WAS REPORTED THAT FROST APPEARED ON THE NEEDLE SHAFT. AN ICESPHERE 90 DEGREE NEEDLE WAS SELECTED FOR USE IN A CRYOABLATION PROCEDURE IN THE KIDNEY. DURING THE PROCEDURE, THE PHYSICIAN PUNCTURED THE NEEDLE INTO THE TUMOR, AND AFTER THE FREEZING STARTED, A THIN LAYER OF FROST BEGAN TO FORM ON ONE NEEDLE. THERE WAS NO FROST ON THE OTHER NEEDLE. THE EVENT OCCURRED AFTER THE INITIAL 10-MINUTE FREEZING, A 10-MINUTE SPONTANEOUS THAWING, AND A SECOND 5-MINUTE FREEZING. FOR THE NEEDLE WITH FROST, THE PHYSICIAN STARTED DRIPPING WARM WATER. ALTHOUGH FROST WAS PRESENT ON ONE NEEDLE, THE FREEZING TREATMENT WAS CONTINUED WHILE PERFORMING THE WARM WATER DROP PROCEDURE. THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15650068 ↗
• MalfunctionJul 29, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE PHYSICIAN USED A CRYOABLATION NEEDLE WITH A SLIGHT BEND AT THE NEEDLE SHAFT. THE NEEDLE TESTED FINE WITH NO VISIBLE LEAK DETECTED, AND THE BENT NEEDLE WAS BARELY NOTICABLE DURING TREATMENT. THE PHYSICIAN PROCEEDED TO USE THE NEEDLE. NEEDLE PLACEMENT WAS UNAFFECTED AND THE NEEDLE DID NOT BEND FURTHER UPON USAGE. THE CASE WAS COMPLETED WITH NO IMPACT TO THE PATIENT. THE LABELLING OF THE PRODUCT STATES THAT BENT NEEDLES SHOULD NOT BE USED FOR CRYOABLATION PROCEDURES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10338929 ↗
• MalfunctionJul 29, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE PHYSICIAN USED A CRYOABLATION NEEDLE WITH A SLIGHT BEND AT THE NEEDLE SHAFT. THE NEEDLE TESTED FINE WITH NO VISIBLE LEAK DETECTED, AND THE BENT NEEDLE WAS BARELY NOTICABLE DURING TREATMENT. THE PHYSICIAN PROCEEDED TO USE THE NEEDLE. NEEDLE PLACEMENT WAS UNAFFECTED AND THE NEEDLE DID NOT BEND FURTHER UPON USAGE. THE CASE WAS COMPLETED WITH NO IMPACT TO THE PATIENT. THE LABELLING OF THE PRODUCT STATES THAT BENT NEEDLES SHOULD NOT BE USED FOR CRYOABLATION PROCEDURES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10338926 ↗
• InjuryJun 21, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IMMEDIATELY AFTER A RENAL CRYOABLATION CASE, THE PHYSICIAN NOTICED A BURN ON THE SKIN OF THE PATIENT CLOSE TO THE ISOLATION SHEATH DUE TO CONTACT WITH THE SKIN. CLARIFICATION WAS RECEIVED THAT THE BURN WAS CAUSED BY FROST ON THE GREY TUBING OF THE NEEDLE. THE PATIENT WAS TREATED WITH TOPICAL OINTMENT. THE NEEDLE WAS NOT RETURNED FOR INVESTIGATION.

  Patient problems: Burn, Thermal

  MAUDE report 8723626 ↗
• MalfunctionNov 5, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE DOCTOR NOTICED THE SHAFT OF ONE OF THE ICESPHERE NEEDLE STARTED TO COLLECT FROST. THE PROCEDURE WAS COMPLETED AS EXPECTED WITH NO INJURY TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8036576 ↗
• MalfunctionMar 2, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE CUSTOMER REPORTED THAT DURING THE FIRST FREEZE CYCLE THE DOCTOR NOTICED THE SHAFT OF ONE OF THE ICESPHERE 1.5 90 CRYOABLATION NEEDLE STARTED TO COLLECT FROST. THERE WAS NO INJURY TO THE PATIENT REPORTED. THE CUSTOMER DID NOT PROVIDE ANY ADDITIONAL INFORMATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7308796 ↗
• MalfunctionJan 2, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  DURING THE TESTING OF 2 ICESPHERE NEEDLES, ONE NEEDLE SHAFT STARTED TO COLLECT FROST IMMEDIATELY. NEEDLE WAS REPLACED TO CONTINUE WITH TESTING. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 7158230 ↗
• MalfunctionSep 26, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  PRIOR TO A CRYOABLATION PROCEDURE, TWO ICESPHERE 1.5 90 NEEDLES AND SYSTEM TESTED FINE WITH NO ISSUES TO REPORT. TOWARDS THE END OF THE FIRST FREEZE CYCLE THE DOCTOR NOTICED THE SHAFT OF ONE OF THE NEEDLE STARTED TO COLLECT FROST. THE PATIENT'S SKIN WAS COVERED WITH SALINE TO PREVENT ANY INJURY. THE PROCEDURE WAS COMPLETED AS EXPECTED WITH NO INJURY TO THE PATIENT. THE SIZE OF THE ICEBALL WAS REPORTEDLY GOOD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6895469 ↗
• MalfunctionSep 12, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  PRIOR TO A CRYOABLATION PROCEDURE, ICESPHERE 1.5 NEEDLES AND SYSTEM TESTED FINE WITH NO ISSUES TO REPORT. A COUPLE OF MINUTES INTO THE FIRST FREEZE CYCLE THE DOCTOR NOTICED THE SHAFT OF ONE OF THE NEEDLES STARTED TO COLLECT FROST. THE PATIENT'S SKIN WAS COVERED WITH SALINE TO PREVENT ANY INJURY. THE PROCEDURE WAS COMPLETED AS EXPECTED WITH NO INJURY TO THE PATIENT. THE USER IS EXPERIENCED AND REPORTED THE SIZE AND FORMATION OF THE ICEBALL WAS GOOD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6860082 ↗
• MalfunctionJul 18, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED THAT DURING A RENAL CRYOABLATION PROCEDURE, THE DOCTOR NOTICED THAT INSULATION ON AN ICESPHERE FAILED. THE PATIENT'S SKIN WAS COVERED WITH GEL TO PREVENT ANY INJURY. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6723828 ↗
• MalfunctionJun 1, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  DURING A PERC RENAL PROCEDURE AN ISSUE WITH ICESPHERE PLUS NEEDLE WAS OBSERVED. THE DOCTOR NOTICED THE SHAFT OF THE ICESPHERE NEEDLE STARTED TO COLLECT FROST. THE PATIENT'S SKIN WAS COVERED WITH SALINE TO PREVENT FROSTBITE. THE PROCEDURE WAS COMPLETED AS EXPECTED WITH NO INJURY TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6606488 ↗