ThermaCor 1200 Infusion System TSS-1200Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00857893006110), received between Sep 26, 2019 and Nov 22, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (2 reports).

3 other recalls cover devices cleared under the same FDA submission (K052055, K202461); 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 22, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE THERMACOR 1200 RAPID INFUSION SYSTEM WAS BEING USED AT (B)(6) MEDICAL CENTER ON (B)(6) 2024, AND DURING A PROCEDURE, THE HOSPITAL STATED THE RETURN LINE ON THE 3 SPIKE SET DETACHED AND CAUSED BLOOD TO LEAK AT THE LINE CONNECTION. THE SET WAS REPLACED AND THE SURGERY CONTINUED. NO PATIENT INJURY OR EXTENDED TIME TO SURGERY WAS NOTED BY THE HOSPITAL. THE DHR WAS REVIEWED, AND NO ISSUE WAS NOTED DURING ASSEMBLY OR DURING LEAK TESTING. THE 3 SPIKE SET WAS RETURNED BY THE HOSPITAL, AND THE INVESTIGATION WAS COMPLETED. THE RETURNED 3 SPIKE SET CONNECTIONS WERE CHECKED AND VERIFIED TO MEET SPECIFICATIONS. DURING THE INSPECTION, IT WAS NOTED THAT THE ONE-WAY VALVE THAT THE BARB IS ATTACHED TO WAS PLACED PROPERLY AND THERE WERE NO ISSUES NOTED WITH THE VALVE. IT WAS INSTALLED CORRECTLY, AND 15PSI OF AIR WAS SENT THROUGH IT. WHEN AIR WAS SENT IN THE OTHER DIRECTION, THE VALVE SHUT AND BLOCKED THE AIR ACCESS AS IT SHOULD. THE RETAIN SAMPLE WAS TESTED AND NO ISSUE WAS NOTED. THE RETAIN SAMPLE WAS OPENED, AND THE RETURN LINE CONNECTION WAS SECURE. NO ISSUE HAS BEEN NOTED FOR THIS LOT OF CASSETTES WITH THE 3 SPIKE SETS IN THE FIELD. THERE IS NO INVENTORY LEFT AVAILABLE FOR THIS LOT OF CASSET

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20762092 ↗
• MalfunctionSep 26, 2019Fluid/Blood Leak; Leak/Splash; Mechanical Problem; Fluid/Blood Leak; Leak/Splash; Mechanical Problem

  THE THERMACOR 1200 INFUSION SYSTEM WAS BEING USED AT (B)(6) ON (B)(6) 2019. THE HOSPITAL STATED THE 3 SPIKE SET (TUBING SET FOR THE PTC-1200) STARTED LEAKING BLOOD DURING SURGERY. THE 3 SPIKE SET WAS CHANGED OUT, AND THE SURGERY CONTINUED WITH THE THERMACOR 1200 SYSTEM. NO PATIENT INJURY OR EXTENDED SURGERY TIME WAS NEEDED FOR CHANGING OUT THE 3 SPIKE SET.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9126145 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K052055, K202461. One submission often covers many models, so check the product and lot details in each record.

• Z-1260-2021 · Feb 18, 2021 · Terminated
  ThermaCor 1200 Disposable Sets Components of the Smisson-Cartledge Biomedical ThermaCor 1200 Rapid Thermal Infusion System, used for infusion of: -crystalloid, colloid, or blood
• Z-1258-2021 · Feb 18, 2021 · Terminated
  ThermaCor 1200 Disposable Sets Components of the Smisson-Cartledge Biomedical ThermaCor 1200 Rapid Thermal Infusion System, used for infusion of: -crystalloid, colloid, or blood p
• Z-1259-2021 · Feb 18, 2021 · Terminated
  ThermaCor 1200 Disposable Sets Components of the Smisson-Cartledge Biomedical ThermaCor 1200 Rapid Thermal Infusion System, used for infusion of: -crystalloid, colloid, or blood