IceFORCE™ 2.1 CX L 90° Cryoablation Needle FPRPR3618Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07290104831089), received between Aug 26, 2019 and May 18, 2020 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Defective Device” (1 report).

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-0659-2021 · 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-2683-2020 · Root cause: Nonconforming Material/Component · 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.

• MalfunctionMay 18, 2020Defective Device; Defective Device

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED MUSCLE STIMULATION DURING ACTIVE THAW (ITHAW). PATIENT UNDERWENT A RENAL CRYOABLATION PROCEDURE WITH 4 ICEFORCE AND 1 ICEFORCE LONG NEEDLES. DURING THE ITHAW STEP OF THE PROCEDURE, THE PATIENT TOLD THE NURSE THAT THE "THING ON THEIR BACK" WAS CAUSING HIM TO MOVE. THE MUSCLE STIMULATION STOPPED IMMEDIATELY WHEN THE ITHAW FEATURE WAS TURNED OFF. THE PHYSICIAN CONTINUED THE CASE USING PASSIVE THAW, AND THE CASE WAS SUCCESSFULLY COMPLETED WITH NO REPORTED PATIENT INJURY OR FURTHER COMPLICATIONS. THE NEEDLE CAUSING THE MUSCLE STIMULATION WAS NOT IDENTIFIED, AS THE PHYSICIAN DID NOT WANT TO CAUSE ANOTHER SHOCK TO THE PATIENT WHILST TRYING TO IDENTIFY THE INDIVIDUAL NEEDLE CAUSING THE PROBLEM.

  Patient problems: Cramp(s) /Muscle Spasm(s); Muscle Spasm(s)

  MAUDE report 10066145 ↗
• MalfunctionFeb 12, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  TWO NEEDLES WERE USED DURING A CRYOABLATION CASE. THIS MDR IS BEING SUBMITTED FOR THE SECOND OF THE NEEDLES USED DURING THE CRYOABLATION PROCEDURE. DURING THE ACTIVE THAW CYCLE TOWARDS THE END OF THE PROCEDURE, ONE OF THE TWO NEEDLES CAUSED MUSCLE STIMULATION. THE CASE WAS COMPLETED, WITH NO REPORTED INJURY TO PATIENT. THE USER IS UNSURE WHICH OF THE NEEDLES CAUSED THE MUSCLE STIMULATION. THE NEEDLES WILL BE RETURNED TO THE MANUFACTURER FOR INVESTIGATION.

  Patient problems: Muscle Spasm(s)

  MAUDE report 9703434 ↗
• MalfunctionFeb 12, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  TWO NEEDLES WERE USED DURING A CRYOABLATION CASE. THIS MDR IS BEING SUBMITTED FOR THE FIRST OF THE NEEDLES USED DURING THE CRYOABLATION PROCEDURE. DURING THE ACTIVE THAW CYCLE TOWARDS THE END OF THE PROCEDURE, ONE OF THE TWO NEEDLES CAUSED MUSCLE STIMULATION. THE CASE WAS COMPLETED, WITH NO REPORTED INJURY TO PATIENT. THE USER IS UNSURE WHICH OF THE NEEDLES CAUSED THE MUSCLE STIMULATION. THE NEEDLES WILL BE RETURNED TO THE MANUFACTURER FOR INVESTIGATION.

  Patient problems: Muscle Spasm(s)

  MAUDE report 9703425 ↗
• MalfunctionJan 3, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THREE NEEDLES WERE USED FOR A RENAL CRYOABLATION PROCEDURE. THE NEEDLES WERE TESTED WITH NO ISSUES. DURING THE FIRST FREEZE CYCLE, ONE OF THE NEEDLE'S CAUSED THE PATIENT TO TWITCH. THE CASE WAS COMPLETED AS EXPECTED. THE NEEDLES WILL BE RETURNED FOR INVESTIGATION.

  Patient problems: Muscle Spasm(s)

  MAUDE report 9547949 ↗
• MalfunctionJan 2, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A PATIENT UNDERWENT CRYOABLATION FOR A RENAL CASE WITH FIVE ICEFORCE NEEDLES. THE PATIENT WAS UNDER CONSCIOUS SEDATION. DURING ACTIVE THAW CYCLE, THE PATIENT EXPERIENCED MUSCLE SPASM. PASSIVE THAW WAS USED TO COMPLETE THE CASE AS EXPECTED WITH NO PATIENT INJURY. IT IS UNKNOWN WHICH NEEDLE CAUSED THE STIMULATION; THEREFORE ALL FIVE NEEDLES WILL BE RETURNED FOR INVESTIGATION.

  Patient problems: Muscle Spasm(s)

  MAUDE report 9538114 ↗
• MalfunctionAug 26, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING THE FREEZE CYCLE OF A CRYOABLATION PROCEDURE, FROST COLLECTED ON THE SHAFT OF THE NEEDLE. THE PATIENT'S SKIN WAS PROTECTED AND THE CASE WAS COMPLETED WITH NO INJURY TO THE PATIENT. THE NEEDLE WAS RETURNED FOR INVESTIGATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8932681 ↗