Integra® Miltex® 33516Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10381780171959), received between Jan 17, 2024 and Sep 17, 2025 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Explosion” (2 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-1103-2025 · Root cause: Device Design · FDA record ↗

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.

• MalfunctionSep 17, 2025Leak/Splash; Leak/Splash

  A FACILITY REPORTED THAT CRYOSOLUTIONS 10PK CARTRG (33516) 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 23078541 ↗
• MalfunctionJan 8, 2025Leak/Splash; Leak/Splash

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21107708 ↗
• InjuryFeb 16, 2024Explosion; Explosion

  THIS IS 1 OF 2 REPORTS FOR THE CRYOSOLUTIONS CARTRIDGE USED DURING THIS EVENT AND IS LINKED TO MFG NUMBER 3014334038-2024-00032. IT WAS REPORTED THAT A PHYSICIAN WAS BURNED WHEN HANDLING THE CRYOSOLUTIONS 10PK CARTRIDGE (33516). STAFF WAS USING A NEW LOT OF CARTRIDGES AND ONE EXPLODED WITH LIQUID NITROGEN WHEN APPLYING A NEW CARTRIDGE TO THE CRYOPEN. IT IS UNKNOWN WHETHER MEDICAL INTERVENTION WAS REQUIRED. NO PATIENT INJURY OR SURGICAL DELAY HAS BEEN REPORTED.

  Patient problems: Caustic/Chemical Burns

  MAUDE report 18727449 ↗
• InjuryJan 17, 2024Explosion; Explosion

  IT WAS REPORTED THAT THE PHYSICIAN WAS ATTEMPTING TO ATTACH A NEW CARTRIDGE/CRYOSOLUTIONS 10PK CARTRIDGE (33516) TO THE PEN AND IT "EXPLODED" WITH LIQUID NITROGEN. IT SPRAYED BOTH OF THE PHYSICIAN'S HAND RESULTING IN THE PHYSICIAN GETTING MINOR BURNS ON HER HANDS BEFORE SHE COULD SAFELY PUT IT DOWN. THE ENTIRE PEN AND CARTRIDGE BECAME COVERED IN FROST. IT IS UNKNOWN WHETHER MEDICAL INTERVENTION WAS REQUIRED. NO PATIENT INJURY OR SURGICAL DELAY HAS BEEN REPORTED.

  Patient problems: Burn(s)

  MAUDE report 18531860 ↗

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;