Integra® Miltex® 33510Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10381780171898), received between Feb 6, 2024 and Aug 27, 2025 — classified as 5 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (13 reports).

2 other recalls cover devices cleared under the same FDA submission (K091721); they may or may not involve this specific model.

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 16, 2026.

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 27, 2025Leak/Splash; Leak/Splash

  A FACILITY REPORTED THAT DURING A PROCEDURE, THE CRYOSOLUTIONS SET WITH 1 CARTRIDGE/1MM TIP (33510) WAS COMING OUT FROM THE SIDE AND WAS NOT FUNNELING PROPERLY THROUGH THE NOZZLE. THERE WERE NO DEATH, INJURIES, OR SURGICAL DELAYS REPORTED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22907311 ↗
• MalfunctionAug 20, 2025Leak/Splash; Leak/Splash

  A FACILITY REPORTED THAT THE CRYOSOLUTIONS SET WITH 1 CARTRIDGE/1MM TIP (33510) WAS NOT WORKING. IT WAS REPORTED THAT WHEN THEY TRIED TO ATTACH A NEW CANISTER, IT SPRAYED OUT THROUGH THE SMALL HOLES IN THE THREAD. THERE WAS NO PATIENT INVOLVEMENT; THUS, NO PATIENT INJURY, DEATH, OR SURGICAL DELAY OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22849878 ↗
• MalfunctionAug 4, 2025Leak/Splash; Leak/Splash

  A FACILITY REPORTED THAT THE CRYOSOLUTIONS SET WITH 1 CARTRIDGE/1MM TIP (33510) WAS NOT WORKING PROPERLY. IT WAS REPORTED THAT THE LIQUID WAS COMING FROM THE BOTTOM WHEN THE DOCTOR TRIED TO SPRAY IT ON THE AFFECTED AREA. NO PATIENT INJURY, DEATH, OR SURGICAL DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22709615 ↗
• MalfunctionJul 8, 2025Leak/Splash; Leak/Splash

  A FACILITY REPORTED THAT THE CRYOSOLUTIONS SET WITH 1 CARTRIDGE/1MM TIP (33510) LEAKED WHEN IT WAS ATTACHED TO THE CANISTER. THE ISSUE OCCURRED AFTER A TREATMENT. THERE WAS NO PATIENT INVOLVEMENT; THEREFORE, NO INJURIES, DEATHS, OR SURGICAL DELAYS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22440255 ↗
• MalfunctionJul 2, 2025Leak/Splash; Leak/Splash

  A FACILITY REPORTED THAT BEFORE A PROCEDURE WAS PERFORMED, THE CARTRIDGE OF THE CRYOSOLUTIONS SET WITH 1 CARTRIDGE/1MM TIP (33510) WAS ATTACHED TO THE TIP AND GAS LEAKED FROM THE PEN. WHEN THE CARTRIDGE WAS FULLY ON AND TIGHT, THE GAS CONTINUED TO LEAK OUT OF THE HOLES AROUND THE CARTRIDGE TIP, EVEN THOUGH THE LEVER WAS NOT BEING PUSHED DOWN. THERE WAS NO PATIENT INVOLVEMENT; THUS, NO INJURY, DEATH OR SURGICAL DELAY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22391718 ↗
• MalfunctionMay 28, 2025Leak/Splash; Leak/Splash

  A FACILITY REPORTED THAT THE CRYOSOLUTIONS SET WITH 1 CARTRIDGE/1MM TIP (33510) "DOES NOT SEEM TO SEAL CORRECTLY". THE FACILITY INDICATED THAT THEY "FOLLOWED THE INSTRUCTIONS AND IT SEEMED TO LEAK THE CARTRIDGE", PREVENTING THEM FROM USING THE DEVICE. NO INJURY, DEATH OR SURGICAL DELAY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22096709 ↗
• InjuryMay 13, 2025Leak/Splash; Use of Device Problem; Leak/Splash; Use of Device Problem

  A FACILITY REPORTED THAT ON TWO DIFFERENT OCCASIONS, THE PHYSICIAN WAS UNABLE TO SCREW THE CARTRIDGES/CRYOSOLUTIONS SET WITH 1 CARTRIDGE/1MM TIP (33510) IN QUICKLY ENOUGH. IN THE SAME INSTANCES, THEY BOTH COMPLETELY EMPTIED BEFORE SHE WAS ABLE TO GET THEM ATTACHED SUCCESSFULLY". IT WAS REPORTED THAT WHEN THE PHYSICIAN TRIED TO ATTACH THE SECOND CARTRIDGE, IT "MALFUNCTIONED AND LEAKED CAUSING A BURN ON HER FINGER". IT WAS REPORTED THAT THE "PROCEDURE WAS NOT PERFORMED. DEVICE MALFUNCTIONED PRIOR TO PROCEDURE INITIATION". THE PATIENT WAS REPORTEDLY "UNHARMED/NOT INVOLVED IN THE INCIDENT".

  Patient problems: Burn(s)

  MAUDE report 22010319 ↗
• MalfunctionFeb 7, 2025Leak/Splash; Leak/Splash

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21339862 ↗
• MalfunctionJan 8, 2025Leak/Splash; Leak/Splash

  THIS REPORT IS 1 OF 2 FOR THE CRYOSOLUTIONS SET WITH 1 CARTRIDGE (33510) REPORTEDLY USED DURING THIS EVENT AND IS RELATED TO MANUFACTURER NUMBER: 3014334038-2025-00002. A FACILITY REPORTED THAT THE DEVICE WAS LEAKING. THE USER REPORTEDLY CHANGED TO A NEW CARTRIDGE AND AS IT WAS BEING SCREWED IN TO THE CRYOSOLUTIONS PEN FROM THE CRYOSOLUTIONS SET WITH 1 CARTRIDGE (33510), "IT RELEASED ALL THE NITRO IN A SINGLE BURST FREEZING THE DEVICE AND THE GLOVES." THERE WAS NO PATIENT INVOLVEMENT NOR INJURY TO THE USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21107709 ↗
• MalfunctionSep 20, 2024Leak/Splash; Leak/Splash

  A FACILITY REPORTED THAT DURING TESTING PRIOR TO SURGERY, THE DOCTOR TRIED TO USE THE TRIGGER MECHANISM OF THE CRYOSOLUTIONS SET WITH 1 CARTRIDGE/1MM TIP (33510), AND THE WHOLE CARTRIDGE DISCHARGED. NO INJURY OR SURGICAL DELAY HAS BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20266868 ↗
• MalfunctionJun 25, 2024Leak/Splash; Leak/Splash

  THIS REPORT IS 1 OF 2 FOR THE CRYOSOLUTIONS PEN USED DURING THIS EVENT AND IS LINKED TO MFG NUMBER 3014334038-2024-00136: A FACILITY REPORTED THAT THE USER TRIED TO CONNECT A NEW CARTRIDGE TO THE CRYOSOLUTIONS PEN/CRYOSOLUTIONS SET WITH 1 CARTRIDGE/1MM TIP (33510) AND THE CONTENTS OF THE CARTRIDGE STARTED SPILLING/SPEWED OUT. THE CUSTOMER SUSPECTS THAT THE DEFECT IS THE PEN. IT WAS REPORTED THAT NO PATIENT INJURY OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19611633 ↗
• InjuryFeb 27, 2024Leak/Splash; Leak/Splash

  N/A.

  Patient problems: Caustic/Chemical Burns

  MAUDE report 18794173 ↗
• InjuryFeb 27, 2024Leak/Splash; Leak/Splash

  N/A

  Patient problems: Caustic/Chemical Burns

  MAUDE report 18794053 ↗
• InjuryFeb 16, 2024Explosion; Explosion

  THIS IS 2 OF 2 REPORTS FOR THE CRYOSOLUTIONS SET/PEN USED DURING THIS EVENT AND IS LINKED TO MFG NUMBER 3014334038-2024-00020. IT WAS REPORTED THAT A PHYSICIAN WAS BURNED WHEN HANDLING THE CRYOSOLUTIONS SET WITH 1 CARTRIDGE/1MM TIP (33510). STAFF WAS USING A NEW LOT OF CARTRIDGES AND ONE EXPLODED WITH LIQUID NITROGEN WHEN APPLYING A NEW CARTRIDGE TO THE CRYOPEN. THE REPORTER STATED "MAYBE IT IS THE PEN". IT IS CURRENTLY UNKNOWN WHETHER MEDICAL INTERVENTION WAS REQUIRED. NO PATIENT INJURY OR SURGICAL DELAY HAS BEEN REPORTED.

  Patient problems: Caustic/Chemical Burns

  MAUDE report 18727446 ↗
• InjuryFeb 6, 2024Explosion; Explosion

  A FACILITY REPORTED THAT THE CRYOSOLUTIONS SET WITH 1 CARTRIDGE (33510) GLASS TIP EXPLODED WHILE IN USE DURING WART CRYOTHERAPY. THE PHYSICIAN SUSTAINED MILD CHEMICAL SURFACE BURN WHILE USING THE PRODUCT. THE PROCEDURE WAS STOPPED IMMEDIATELY AND WAS NOT RESUMED. IT WAS REPORTED THAT THE PHYSICIAN'S BURNS ARE HEALING. NO PATIENT INJURY WAS REPORTED.

  Patient problems: Cryogenic Burn

  MAUDE report 18650505 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K091721. One submission often covers many models, so check the product and lot details in each record.

• Z-1103-2025 · Dec 19, 2024 · Open, Classified
  Integra Miltex CryoSolutions Cartridges 10 Pack (23.5g N2O each), Model: C-CA-23, Item: 33516;
• Z-1104-2025 · Dec 19, 2024 · Open, Classified
  Integra Miltex Cryosolutions Cartridges 4 Pack (23.5g N2O each), Model: C-CA-23, Item: 33517;