IceSphere® 1.5 S 90° Cryoablation Needle FPRPR3561Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07290104830556), received between Mar 18, 2019 and Jun 26, 2023 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Wrong Label” (2 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-0672-2021 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJun 26, 2023Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT PNEUMATOSIS OCCURRED AFTER USE OF THE CRYOABLATION NEEDLE. AN ICESPHERE S 90 DEGREE NEEDLE WAS SELECTED FOR A CRYOABLATION PROCEDURE TO TREAT A KIDNEY LESION. THE PROBE WAS TESTED. IT WAS REPORTED THAT NO GAS LEAKS WERE SEEN, AND THE ICE BALL WAS VISUALIZED; HOWEVER, THERE WAS ONE SMALL BUBBLE SEEN, BUT NO STREAM OF BUBBLES. THE PHYSICIAN INSPECTED THE NEEDLE AND DETERMINED THAT IT LOOKED FINE, SO THE NEEDLE WAS USED. THE PROBE WAS INSERTED INTO THE PATIENT THROUGH THE POSTERIOR BACK MUSCLE, AND IT COULD NOT BE VISUALIZED ON THE SCREEN, SO IT WAS LOCKED INTO THE CHANNEL AGAIN AND PROMPTED TO RE-TEST IT. THIS TIME, THE PROBE WAS TESTED INSIDE THE PATIENT. THE FIRST FREEZE WAS COMPLETED WITH NO ISSUE. AT THE END OF THE SECOND FREEZE, HOWEVER, AFTER 10 MINUTES, THE CT IMAGE SHOWED AIR IN THE SUBCUTANEOUS MUSCLE. THE NEEDLE WAS REMOVED AND RE-TESTED IN SALINE. SMALL BUBBLES WERE SEEN FROM WHERE THE NEEDLE MEETS THE HANDLE. AFTER PRESSING THE FREEZE FUNCTION WHILE IN THE SALINE, MULTIPLE GAS BUBBLES WERE PRESENT. THE NEEDLE HAD BEEN COMPLETED SUCCESSFULLY WITH THE ORIGINAL DEVICE. THE PATIENT WAS IN STABLE CONDITION AFTER THE PROCEDURE, AND NO INTERVENTION WAS NEEDE

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 17201669 ↗
• MalfunctionJan 18, 2023Wrong Label; Wrong Label

  IT WAS REPORTED THAT THE DEVICE PACKAGING WAS MISLABELED. AN ICESPHERE S 90 DEGREE NEEDLE WAS OPENED FROM THE PACKAGING. THE PACKAGE INCORRECTLY LABELED THE ICESPHERE S 90 DEGREE NEEDLE AS A 175CM NEEDLE INSTEAD OF A 100CM NEEDLE. THE NEEDLE WAS NOT USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16196883 ↗
• MalfunctionJan 18, 2023Wrong Label; Wrong Label

  IT WAS REPORTED THAT THE DEVICE PACKAGING WAS MISLABELED. AN ICESPHERE S 90 DEGREE NEEDLE WAS OPENED FROM THE PACKAGING. THE PACKAGE INCORRECTLY LABELED THE ICESPHERE S 90 DEGREE NEEDLE AS A 175CM NEEDLE INSTEAD OF A 100CM NEEDLE. THE NEEDLE WAS NOT USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16196881 ↗
• MalfunctionOct 27, 2020Thermal Decomposition of Device; Thermal Decomposition of Device

  IT WAS REPORTED THAT THE INSULATION OF A CRYOABLATION NEEDLE FAILED DURING A PROCEDURE. THE ICESPHERE NEEDLE PASSED INTEGRITY TESTING WITHOUT ISSUE; HOWEVER, THREE MINUTES INTO THE FIRST FREEZE CYCLE FROST DEVELOPED ON THE NEEDLE SHAFT. THE PHYSICIAN USED STERILE WARMING BAGS AND SALINE TO PROTECT THE PATIENT'S SKIN UNTIL THE NEEDLE WAS PASSIVELY THAWED. THE DEVICE WAS REMOVED AND REPLACED WITH A NEW ICESPHERE NEEDLE. NO PATIENT COMPLICATIONS WERE ENCOUNTERED AND THE TREATMENT WAS COMPLETED SUCCESSFULLY WITHOUT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10744654 ↗
• InjuryMar 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SHORTLY, AFTER A NERVE PROCEDURE WAS COMPLETED THAT PATIENT EXPERIENCED PAIN. ONE DOSE OF MORPHINE WAS GIVEN AND THE PATIENT FELT FINE. THE HOSPITAL TECHNICIAN THOUGHT THE PAIN WAS DUE TO HYDRO DISSECTION. THERE WAS NO ALLEGED DEVICE MALFUNCTION. NO OTHER DETAILS PROVIDED SUGGEST A MORE SIGNIFICANT PROCEDURE RELATED ISSUE.

  Patient problems: Pain

  MAUDE report 8429972 ↗