Integra® Miltex® 33517Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10381780171966), received between Feb 27, 2024 and Aug 17, 2026 — classified as 5 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (12 reports).

1 FDA recall record name this device's identifier, 1 still open.

1 other recall 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.

Recalls naming this device

1. Dec 19, 2024Open, Classified

   During the assembly of the cartridge to its connecting body part, the valve may open prematurely resulting in partial or complete emptying of the cartridge before its intended use.

   Z-1104-2025 · Root cause: Device Design · FDA record ↗

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• OtherAug 17, 2026Nonstandard Device

  Patient problems: Numbness

  MAUDE report 50274694 ↗
• InjuryMar 16, 2026Insufficient Device Problem Information

  N/A.

  Patient problems: Burn(s)

  MAUDE report 24606354 ↗
• MalfunctionSep 17, 2025Leak/Splash; Leak/Splash

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23078427 ↗
• MalfunctionSep 17, 2025Leak/Splash; Leak/Splash

  A FACILITY REPORTED THAT CRYOSOLUTIONS 4PK CARTRGE (33517) CONTINUES TO LEAK AFTER BEING REPAIRED. THERE WAS NO PATIENT INVOLVEMENT; THEREFORE, NO INJURIES, DEATHS, OR SURGICAL DELAYS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23078374 ↗
• MalfunctionSep 16, 2025Leak/Splash; Leak/Splash

  A FACILITY REPORTED THAT CRYOSOLUTIONS 4PK CARTRGE (33517) CONTINUES TO LEAK AFTER BEING REPAIRED. THERE WAS NO PATIENT INVOLVEMENT; THEREFORE, NO INJURIES, DEATHS, OR SURGICAL DELAYS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23063758 ↗
• MalfunctionJul 23, 2025Leak/Splash; Leak/Splash

  A FACILITY REPORTED THAT THE CRYOSOLUTIONS 4PK CARTRIDGE (33517) CANISTER LEAKED OR SPRAYED "CRYO" WHEN ATTACHED TO THE ADAPTER ON MORE THAN ONE OCCASION. THERE WAS NO PATIENT INVOLVEMENT; THUS, NO DEATHS, INJURIES, OR SURGICAL DELAYS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22575595 ↗
• MalfunctionJul 23, 2025Leak/Splash; Leak/Splash

  N/A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22575591 ↗
• MalfunctionJul 2, 2025Burst Container or Vessel; Burst Container or Vessel

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22391769 ↗
• MalfunctionMay 13, 2025Leak/Splash; Leak/Splash

  A FACILITY REPORTED THAT THEY WERE UNABLE TO SUCCESSFULLY ATTACH THE CRYOSOLUTIONS 4PK CARTRIDGE (33517) TO THE CONTROL MECHANISM WITHOUT GAS LEAKING OUT. THE O-RINGS APPEARED TO BE PROPERLY IN PLACE. THE EVENT OCCURRED BEFORE ATTEMPTING A PROCEDURE ON AN ANIMAL PATIENT. NO ADVERSE EVENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22013357 ↗
• MalfunctionApr 29, 2025Leak/Splash; Leak/Splash

  A FACILITY REPORTED THAT WHEN THEY "TRIED TO PUT IN THE CARTRIDGE/CRYOSOLUTIONS 4PK CARTRIDGE (33517) ON THE CANISTER, IT RELEASE A NITROUS OXIDE EVERYWHERE." IT IS UNKNOWN WHETHER THERE WAS PATIENT INVOLVEMENT; HOWEVER, NO INJURY, DEATH, OR SURGICAL DELAY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21926899 ↗
• MalfunctionFeb 18, 2025Leak/Splash; Leak/Splash

  A FACILITY REPORTED THAT THE CARTRIDGE/CRYOSOLUTIONS 4PK CARTRIDGE (33517) SPEWED GAS WHEN TRYING TO ATTACH IT TO THE CRYOSOLUTIONS CONTROL MECHANISM BEFORE AND DURING PROCEDURES. THE DEVICE WAS NOT IN CONTACT WITH A PATIENT; THUS, NO INJURY, DEATH, OR SURGICAL DELAY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21405128 ↗
• MalfunctionDec 29, 2024Leak/Splash; Leak/Splash

  A FACILITY REPORTED THAT THERE WAS A "MASSIVE LEAK WHEN THE CARTRIDGES/CRYOSOLUTIONS CARTRIDGES (33517) WERE INSERTED IN 2 DEVICES." THERE WAS NO PATIENT INVOLVEMENT; THUS, NO INJURY OR SURGICAL DELAY OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21032284 ↗
• InjuryAug 29, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  N/A.

  Patient problems: Cryogenic Burn

  MAUDE report 20093285 ↗
• MalfunctionJun 25, 2024Leak/Splash; Leak/Splash

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19611632 ↗
• InjuryMay 24, 2024Explosion; Explosion

  A FACILITY REPORTED THAT WHEN THE USER PUSHED THE "TWIST" ON THE CARTRIDGE / CRYOSOLUTIONS 4PK CARTRIDGE (33517), IT EXPLODED. USER TRIED AGAIN WITH A SECOND CARTRIDGE, TWISTED ON IT AND IT EXPLODED WHEN TRYING TO REPLACE IT. IT WAS REPORTED THAT THE DOCTOR BURNED HIS FINGER FROM THE CARTRIDGE. NO USER OUTCOME, NOR MEDICAL INTERVENTION WAS NOT REPORTED.

  Patient problems: Cryogenic Burn

  MAUDE report 19391934 ↗
• InjuryFeb 27, 2024Leak/Splash; Leak/Splash

  THIS REPORT IS 1 OF 2 FOR THE CARTRIDGE USED DURING THIS EVENT AND IS LINKED TO MFG NUMBER 3014334038-2024-00042. A FACILITY REPORTED THAT BEFORE A PROCEDURE, WHEN THE END USER STARTED SCREWING A CARTRIDGE OF THE CRYOSOLUTIONS 4PK CARTRIDGE (33517). GAS SPILLED OUT AND FROZE THE USER'S HANDS. THE USER EXPERIENCED REDNESS AND TENDERNESS TO HANDS. OBSERVATION WAS PERFORMED. THE CARTRIDGES WERE COLLECTED BY THE PRODUCT DISTRIBUTOR.

  Patient problems: Caustic/Chemical Burns

  MAUDE report 18794052 ↗
• InjuryFeb 27, 2024Leak/Splash; Leak/Splash

  N/A.

  Patient problems: Caustic/Chemical Burns

  MAUDE report 18794051 ↗

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;