Integra® Miltex® 33518Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10381780171973), received between Sep 24, 2024 and Aug 11, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (2 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 11, 2025Leak/Splash; Leak/Splash

  A FACILITY REPORTED THAT WHEN THEY ATTACHED THE CRYOSOLUTIONS 1PK CARTRGE (33518) DURING A PROCEDURE, ALL OF THE AIR CAME OUT AT ONCE. NO INJURIES, DEATH, OR SURGICAL DELAY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22770673 ↗
• MalfunctionJul 2, 2025Leak/Splash; Leak/Splash

  A FACILITY REPORTED THAT THREE OF THE CRYOSOLUTIONS 1PK CARTRIDGE (33518) WERE LEAKING. IT IS UNKNOWN UNDER WHAT CIRCUMSTANCE THIS EVENT OCCURRED; HOWEVER, NO INJURY, DEATH OR SURGICAL DELAY WAS REPORTED. IT IS NOTED THAT THE REPORTING FACILITY IS A VETERINARY CENTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22391768 ↗
• MalfunctionFeb 3, 2025Gas/Air Leak; Gas/Air Leak

  A FACILITY REPORTED THAT WHEN THEY WENT TO USE THE CRYOSOLUTIONS 1PK CARTRIDGE (33518) ALL THE GAS CAME OUT. THERE HAVE BEEN NO REPORTS OF PATIENT INVOLVEMENT, INJURY, OR SURGICAL DELAY ASSOCIATED WITH THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21297604 ↗
• MalfunctionSep 24, 2024Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT DURING REPLACEMENT OF THE NEW CARTRIDGE/CRYOSOLUTIONS 1PK CARTRIDGE (33518), GAS STARTED SHOOTING OUT OF THE HOLES AT THE BASE OF THE HANDPIECE, COMPLETELY DRAINING THE NEW CARTRIDGE WITHIN A FEW SECONDS. IT WAS CONFIRMED THAT THE O-RING WAS STILL IN PLACE. IT WAS REPORTED THAT THE DEVICE WAS GOING TO BE USED ON AN ANIMAL PATIENT. NO INJURY, DEATH, OR SURGICAL DELAY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20297965 ↗

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