MyOtherm XP® 61399405331Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00613994947741), received between Jan 21, 2026 and Feb 6, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (4 reports).

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.

• MalfunctionFeb 6, 2026Contamination; Delivered as Unsterile Product

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A MYOTHERM HEAT EXCHANGER, IT WAS REPORTED THAT A FOREIGN HAIR-LIKE MATERIAL WAS FOUND INSIDE STERILE PACKAGING. SEE ATTACHED PHOTOS. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24277178 ↗
• MalfunctionFeb 2, 2026Delivered as Unsterile Product

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A MYOTHERM, IT WAS REPORTED THAT 3 KITS WERE CRACKED WHEN THEY OPENED THE SHIPPING BOX. THE PLASTIC COMPONENT OF THE KIT WAS CRACKED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE PLASTIC CONTAINER OF THE PACKAGING WAS BROKEN, THE DEVICE WAS NOT DAMAGED. PRODUCT NOT USED DUE TO BROKEN PLASTIC PACKAGING. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WERE NO MISSING OR WRONG DEVICES OR COMPONENTS IN THE PACKAGE. THE STERILE SEAL WAS NOT INTACT. THE DEVICE WAS SEALED/LOCATED IN THE 'SEAL.'

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24239995 ↗
• MalfunctionFeb 2, 2026Delivered as Unsterile Product

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A MYOTHERM, IT WAS REPORTED THAT 3 KITS WERE CRACKED WHEN THEY OPENED THE SHIPPING BOX. THE PLASTIC COMPONENT OF THE KIT WAS CRACKED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE PLASTIC CONTAINER OF THE PACKAGING WAS BROKEN, THE DEVICE WAS NOT DAMAGED. PRODUCT NOT USED DUE TO BROKEN PLASTIC PACKAGING. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WERE NO MISSING OR WRONG DEVICES OR COMPONENTS IN THE PACKAGE. THE STERILE SEAL WAS NOT INTACT. THE DEVICE WAS SEALED/LOCATED IN THE 'SEAL.'

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24239944 ↗
• MalfunctionJan 21, 2026Delivered as Unsterile Product

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A MYOTHERM, IT WAS REPORTED THAT 3 KITS WERE CRACKED WHEN THEY OPENED THE SHIPPING BOX. THE PLASTIC COMPONENT OF THE KIT WAS CRACKED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE PLASTIC CONTAINER OF THE PACKAGING WAS BROKEN, THE DEVICE WAS NOT DAMAGED. PRODUCT NOT USED DUE TO BROKEN PLASTIC PACKAGING. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WERE NO MISSING OR WRONG DEVICES OR COMPONENTS IN THE PACKAGE. THE STERILE SEAL WAS NOT INTACT. THE DEVICE WAS SEALED/LOCATED IN THE 'SEAL.'

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24130233 ↗