IceSeed® 1.5 90° Cryoablation Needle FPRPR3202Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07290104830235), received between Mar 2, 2022 and Jul 21, 2026 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Thermal Decomposition of Device” (4 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-0675-2021 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJul 21, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT CELLULITIS OCCURRED, REQUIRING INTERVENTION. THE PURPOSE OF THIS ARTICLE WAS TO DESCRIBE A NOVEL CASE SERIES USING RECTAL SPACER GEL TO DISPLACE AND PROTECT THE RECTUM DURING PROSTATE CANCER CRYOABLATION. FIFTY MEN WITH CLINICALLY LOCALIZED GRADE GROUP 1-5 PROSTATE CANCER UNDERWENT CONCURRENT RECTAL SPACER GEL AND PRIMARY (N=27) OR SALVAGE (N=23) PROSTATE CRYOABLATION USING THE SPACEOAR HYDROGEL AND ICEPEARL (2.1 MM/14 GAUGE) AND/OR ICESEED (1.5 MM/17 GAUGE) CRYOABLATION NEEDLE(S). OF THE 50 CASES, THERE WAS ONLY ONE CASE WITH A COMPLICATION OF PERINEAL CELLULITIS, AS A CLAVIEN-DINDO GRADE II COMPLICATION. THE CELLULITIS WAS ABLE TO BE RESOLVED WITH AN INCISION AND DRAINAGE OF THE FLUID COLLECTION AND ANTIBIOTICS. THERE WERE NO FURTHER COMPLICATIONS OBSERVED.

  Patient problems: Cellulitis

  MAUDE report 25896683 ↗
• InjuryMar 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A SEVERE THERMAL BURN OCCURRED, REQUIRING MEDICAL INTERVENTION. AN ICESEED 90 DEGREE NEEDLE WAS SELECTED FOR CRYONEUROLYSIS OF A POST-AMPUTEE NEUROMA PROXIMAL TO THE SKIN. AT THE TIME OF THE PROCEDURE, THERE WERE NO COMPLICATIONS, AND NO ABNORMAL FROST WAS OBSERVED ON THE NEEDLE. THE SKIN WAS PROTECTED WITH A GLOVE FILLED WITH WARM SALINE AND A HEAT PACK FOLLOWING THE PROCEDURE. HOWEVER, AT AN EMERGENT FOLLOW-UP, THE APPEARANCE OF BLACK SKIN AT THE ABLATION ZONE WAS OBSERVED. THE THERMAL INJURY IS BEING TREATED BY THE VASCULAR WOUND CARE TEAM.

  Patient problems: Full thickness (Third Degree) Burn

  MAUDE report 18989057 ↗
• MalfunctionSep 20, 2023Thermal Decomposition of Device; Thermal Decomposition of Device

  IT WAS REPORTED THAT FROST WAS OBSERVED ON THE NEEDLE SHAFT. TWO ICESEED 90 DEGREE NEEDLES WERE SELECTED FOR USE IN A CRYONEUROLYSIS PROCEDURE. DURING THE PROCEDURE, FROST FORMED ON THE SHAFT AND HANDLE OF ONE OF THE NEEDLES. THE PHYSICIAN BELIEVED THAT ICE WAS SUPPOSED TO FORM, SO REPLACED THE NEEDLE WITHOUT FROST WITH A NEW ICESEED NEEDLE OF A DIFFERENT LOT; HOWEVER, THAT REPLACEMENT NEEDLE ALSO HAD FROST THAT FORMED ON THE NEEDLE SHAFT. THE STAFF USED PROTECTIVE MEASURES ON THE SKIN WHERE THE FROST ON THE NEEDLE MET THE SKIN, AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17784724 ↗
• MalfunctionSep 20, 2023Thermal Decomposition of Device; Thermal Decomposition of Device

  IT WAS REPORTED THAT FROST WAS OBSERVED ON THE NEEDLE SHAFT. TWO ICESEED 90 DEGREE NEEDLES WERE SELECTED FOR USE IN A CRYONEUROLYSIS PROCEDURE. DURING THE PROCEDURE, FROST FORMED ON THE SHAFT AND HANDLE OF ONE OF THE NEEDLES. THE PHYSICIAN BELIEVED THAT ICE WAS SUPPOSED TO FORM, SO REPLACED THE NEEDLE WITHOUT FROST WITH A NEW ICESEED NEEDLE OF A DIFFERENT LOT; HOWEVER, THAT REPLACEMENT NEEDLE ALSO HAD FROST THAT FORMED ON THE NEEDLE SHAFT. THE STAFF USED PROTECTIVE MEASURES ON THE SKIN WHERE THE FROST ON THE NEEDLE MET THE SKIN, AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17784712 ↗
• MalfunctionNov 14, 2022Thermal Decomposition of Device; Thermal Decomposition of Device

  IT WAS REPORTED THAT THERE WAS FROST OBSERVED ON ONE OF THE NEEDLES. THIS ICESEED 90-DEGREE NEEDLE WAS SELECTED FOR A CRYOABLATION PROCEDURE TO TREAT AN OSTEOMA OSTOIDE ON THE RIGHT FEMUR ON A YOUNG AND THIN PATIENT. A NEEDLE TEST WAS PERFORMED FOR TWO MINUTES WITHOUT ANY ISSUES. PRIOR TO THE CRYO ABLATION TREATMENT, THE PHYSICIAN PERFORMED A BONE BIOPSY AND HAD TO REPOSITION THE NEEDLES MANY TIMES. DURING THE PROCEDURE, SCANS WERE PERFORMED (1MIN, 4MIN, 6MIN, AND 8MIN) TO WATCH THE NEEDLE AND HEMORRHAGE SURVEILLANCE. THE SKIN REMAINED WELL-COLORED ALBEIT COLD, SO SKIN FRICTION WAS CREATED BY THE TECHNICIANS DURING THE "ALL-CRYO" PHASE TO ACTIVATE BLOOD CIRCULATION. A SOLID ICEBALL WAS ABLE TO BE FELT UNDER THE SKIN, AND FROST WAS OBSERVED ON THE SHAFT OF THE ICESEED NEEDLE SO WARM STERILE GEL WAS APPLIED TO THE SKIN. AT 8 MIN INTO TREATMENT, THE CRYO THERAPY WAS DECREASED TO 40% TO HELP REDUCE THE ICEBALL FORMATION. PASSIVE THAW WAS THEN ALLOWED AT 5 MIN, AND THE ICEBALL DISSOLVED UNDER THE SKIN. ANOTHER SCAN WAS PERFORMED PRIOR TO STARTING THE SECOND PHASE OF TREATMENT, AND TREATMENT WAS ONLY PERFORMED AT 70% FOR 5 MINUTES AND THEN 40% FOR THE REMAINING 5 MINUTES. AGAIN, SKIN FRI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15795104 ↗
• MalfunctionMar 2, 2022Thermal Decomposition of Device; Thermal Decomposition of Device

  IT WAS REPORTED FROST ON THE NEEDLE SHAFT OCCURRED. AN ICESEED 90 DEGREE NEEDLE WAS USED DURING CRYOABLATION OF A TIBIAL OSTEOID OSTEOMA. FOUR MINUTES INTO THE FIRST FREEZE CYCLE, FROST WAS OBSERVED ON THE SHAFT OF THE NEEDLE NEAR THE PATIENTS' SKIN. THE SKIN WAS GETTING VERY COLD EVEN WITH THE USE OF A WARM SALINE BAG AS PROTECTION. THE FREEZING PHASE WAS STOPPED AND A COMPUTED TOMOGRAPHY (CT) SCAN FOUND NO ABNORMAL AIR, AND THE ICE BALL COULD BE VISUALIZED IN THE MUSCLE. PASSIVE THAW WAS USED, THEN WHEN THE PATIENTS' SKIN WAS WARM, ANOTHER FREEZING CYCLE WAS ATTEMPTED BUT WAS STOPPED AFTER TWO MINUTES BECAUSE FROST ON THE SHAFT OCCURRED AGAIN. THE NEEDLE WAS REMOVED FROM THE PATIENT AND TESTED AGAIN IN A TRAY OF WATER, NO LEAKS, ABNORMAL FORMATION OF ICE, NO FROST OR UNUSUAL ICE WAS OBSERVED ON THE SHAFT. THE NEEDLE WAS PLACED IN THE PATIENT AGAIN AND A FREEZE CYCLE WAS STARTED, FROST ON THE SHAFT AFTER ONE MINUTE, FREEZE CYCLE WAS STOPPED. THE PHYSICIAN THEN EXCHANGED THE ICESEED NEEDLE FOR AN ICESPHERE NEEDLE USED AT 50% TO COMPLETE TREATMENT BECAUSE NO OTHER ICESEED NEEDLE WAS AVAILABLE ON SITE. TREATMENT WAS COMPLETED SUCCESSFULLY WITH NO COMPLICATIONS POST-TREATMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13652698 ↗