IceFORCE® 2.1 CX Cryoablation Needle FPRPR3604Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07290104831027), received between Dec 22, 2023 and Oct 23, 2024 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Cooling” (2 reports).

2 FDA recall records 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-0658-2021 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. Jun 4, 2020Class IITerminated

   The needle surface deteriorated due to unexpected electrolysis during procedure.

   Z-2677-2020 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryOct 23, 2024Thermal Decomposition of Device; Insufficient Cooling; Thermal Decomposition of Device; Insufficient Cooling

  IT WAS REPORTED FROST OCCURRED ON THE DEVICE AND THE PATIENT EXPERIENCED A SKIN BURN. TWO CRYOABLATION NEEDLES WERE CHOSEN FOR THE CRYOABLATION TREATMENT OF A RENAL TUMOR LOCATED IN THE RIGHT KIDNEY. UNDER COMPUTED TOMOGRAPHY (CT) IMAGING, THE CORRECT PLACEMENT OF THE NEEDLES WAS CONFIRMED. THE FREEZE BEGAN, BUT ABOUT HALFWAY THROUGH THE FIRST FREEZE, THE MACHINE STOPPED FREEZING INTERMITTENTLY. THEY STOPPED THE FREEZE CYCLE AND TOOK THE NEEDLES OUT OF THE MACHINE AND THEN ATTEMPTED TO PLUG THEM BACK IN TO SEE IF IT WOULD RESOLVE THE ISSUE. HOWEVER, THE NEEDLES WOULD NOT GO BACK INTO THE PREVIOUS SLOTS. THE NEEDLES WERE REPOSITIONED IN NEW SLOTS, AND THE FREEZE CYCLE WAS STARTED AGAIN. DURING THE FREEZE, IT WAS NOTICED THAT THE NEEDLES WERE NOT GIVING A TEMPERATURE READING. WHEN THE NEEDLES WERE OBSERVED FOR ANY ICE FORMATION, IT WAS NOTED THAT ONE OF THEM DID NOT LOOK RIGHT. THE MACHINE WAS SHUT OFF IMMEDIATELY. WHEN EXAMINING THE PATIENT, THE SKIN WAS WHITE AND COLD TO THE TOUCH. THE SKIN AROUND THE NEEDLE WAS WARMED UP BY PLACING A HAND OVER THE SKIN. THEY WAITED ABOUT 20 MINUTES AND THEN THE PHYSICIAN TOOK THE 2 CRYOABLATION NEEDLES OUT OF THE KIDNEY. THEY DID A FOLLOW UP CT SC

  Patient problems: Burn(s)

  MAUDE report 20514143 ↗
• InjuryOct 15, 2024Thermal Decomposition of Device; Insufficient Cooling; Thermal Decomposition of Device; Insufficient Cooling

  IT WAS REPORTED FROST OCCURRED ON THE DEVICE AND THE PATIENT EXPERIENCED A SKIN BURN. TWO CRYOABLATION NEEDLES WERE CHOSEN FOR THE CRYOABLATION TREATMENT OF A RENAL TUMOR LOCATED IN THE RIGHT KIDNEY. UNDER COMPUTED TOMOGRAPHY (CT) IMAGING, THE CORRECT PLACEMENT OF THE NEEDLES WAS CONFIRMED. THE FREEZE BEGAN, BUT ABOUT HALFWAY THROUGH THE FIRST FREEZE, THE MACHINE STOPPED FREEZING INTERMITTENTLY. THEY STOPPED THE FREEZE CYCLE AND TOOK THE NEEDLES OUT OF THE MACHINE AND THEN ATTEMPTED TO PLUG THEM BACK IN TO SEE IF IT WOULD RESOLVE THE ISSUE. HOWEVER, THE NEEDLES WOULD NOT GO BACK INTO THE PREVIOUS SLOTS. THE NEEDLES WERE REPOSITIONED IN NEW SLOTS, AND THE FREEZE CYCLE WAS STARTED AGAIN. DURING THE FREEZE, IT WAS NOTICED THAT THE NEEDLES WERE NOT GIVING A TEMPERATURE READING. WHEN THE NEEDLES WERE OBSERVED FOR ANY ICE FORMATION, IT WAS NOTED THAT ONE OF THEM DID NOT LOOK RIGHT. THE MACHINE WAS SHUT OFF IMMEDIATELY. WHEN EXAMINING THE PATIENT, THE SKIN WAS WHITE AND COLD TO THE TOUCH. THE SKIN AROUND THE NEEDLE WAS WARMED UP BY PLACING A HAND OVER THE SKIN. THEY WAITED ABOUT 20 MINUTES AND THEN THE PHYSICIAN TOOK THE 2 CRYOABLATION NEEDLES OUT OF THE KIDNEY. THEY DID A FOLLOW UP CT SC

  Patient problems: Burn(s)

  MAUDE report 20450922 ↗
• MalfunctionDec 22, 2023Insufficient Heating; Difficult to Remove; Insufficient Heating; Difficult to Remove

  IT WAS REPORTED THAT THERE WAS RESISTANCE WHEN REMOVING THE NEEDLE. THIS ICEFORCE 2.1 CX NEEDLE WAS SELECTED FOR USE IN A CRYOABLATION FOR RENAL CELL CARCINOMA. DURING THE PROCEDURE, THERE WAS AN ITHAW MALFUNCTION DURING ACTIVE THAWING. THE PHYSICIAN WAITED SEVERAL MINUTES BEFORE ATTEMPTING TO REMOVE THE NEEDLE, BUT UPON REMOVAL THEY FELT RESISTANCE AND WORRIED ABOUT INTERNAL BLEEDING. THE FIELD INDICATED THAT THE RESISTANCE WAS LIKELY DUE TO NOT ENOUGH TIME ALLOWED FOR PASSIVE THAW. BLEEDING WAS NOT EVIDENT ON POST-CT SCAN, AND FURTHER FOLLOW-UP REGARDING THE PATIENT OUTCOME DID NOT REVEAL ANY PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18387579 ↗