Frigitronics 139Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888937004168), received between Aug 13, 2020 and Jun 9, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Excessive Cooling” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 9, 2021Output Problem

  CUSTOMER STATED: "FREEZES WHILE HOLDING PROBE". 1216677-2021-00127-1, 139 N20 SPHERICAL PROBE, E-COMPLAINT- (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 11964574 ↗
• MalfunctionMay 10, 2021Infusion or Flow Problem; Temperature Problem

  CUSTOMER STATED "EVAL". REPAIR TECH STATED "FOUND - LOW DEFROST FLOW - REPLACED FILTER". (B)(4). N20 SPHERICAL PROBE 139 (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 11797485 ↗
• MalfunctionAug 13, 2020Excessive Cooling; Material Split, Cut or Torn

  ORDER: 94632. FOUND;SILICON TORN. HIGH FREEZE FLOW.15MM SHOULD BE 10MM. REF E-COMPLAINT-(B)(4). N20 SPHERICAL PROBE 139 E-COMPLAINT-(B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10401885 ↗