ThermaCor 1200 Infusion System PTC-1200Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00857893006059), received between Mar 27, 2020 and Mar 9, 2022 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (4 reports).

1 FDA recall record name this device's identifier.

2 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.

Recalls naming this device

1. Feb 18, 2021Class ITerminated

   Customers are being notified of results from a Toxicological Risk Assessment related to potential for aluminum ions to leach into warmed fluids.

   Z-1258-2021 · Root cause: Component design/selection · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 9, 2022Fluid/Blood Leak; Fluid/Blood Leak

  THE THERMACOR 1200 RAPID INFUSION SYSTEM WAS BEING USED AT (B)(6), AND DURING A PROCEDURE, THE HOSPITAL STATED THE CASSETTE STARTED LEAKING FROM THE BOTTOM OF THE CASSETTE. THE HOSPITAL CHANGED OUT THE CASSETTE IN ORDER TO CONTINUE THE SURGERY. NO PATIENT INJURY OR EXTENDED TIME TO SURGERY WAS NOTED BY THE HOSPITAL. THE CASSETTE WAS RETURNED BY THE HOSPITAL, AND THE INVESTIGATION WAS COMPLETED. THE ADHESIVE BONDING WAS NOT SECURE AT TWO LOCATIONS - 1) TUBING THAT ATTACHED TO THE FILTER FOR THE PRESSURE PORT WAS NOT SECURE, AND 2) THE FILTER TO THE PRESSURE PORT WAS NOT SECURE. BOTH OF THESE LOCATIONS USE ADHESIVE FOR SECURING THE PARTS TOGETHER. THE DHR WAS REVIEWED AND NO ISSUE WAS NOTED DURING ASSEMBLY OR DURING LEAK TESTING. THE FINAL CASSETTE ASSEMBLY IS PRESSURE DECAY TESTED, AND THIS LOT DID NOT INDICATE ANY LEAKS. THE RETAIN SAMPLE WAS TESTED AND NO ISSUE WAS NOTED. THE RETAIN SAMPLE WAS OPENED, AND THE CONNECTIONS WERE SECURE ON THE FILTERS AND THE TUBING AND THE FILTERS TO THE PRESSURE PORTS. NO ISSUE HAS BEEN NOTED FOR THIS LOT OF CASSETTES IN THE FIELD. THERE IS NO INVENTORY LEFT AVAILABLE FOR THIS LOT OF CASSETTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13715546 ↗
• MalfunctionOct 20, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  THE THERMACOR 1200 RAPID INFUSION SYSTEM WAS BEING USED AT (B)(6) FOR A MASS BLOOD TRANSFUSION. DURING THE PROCEDURE, THE HOSPITAL STATED THE 3 SPIKE SET SPIKE BECAME DISCONNECTED AND THE RN WAS REQUIRED TO CONTINUALLY RESPIKE. THE PROCEDURE WAS COMPLETED WITH NO EXTRA TIME ADDED TO THE SURGERY OR PATIENT INJURY NOTED. THE 3 SPIKE SET HAS NOT BEEN RETURNED BY THE HOSPITAL WHICH NO FURTHER INVESTIGATION COULD BE PERFORMED ON THE SPIKE DISCONNECTING. NO OTHER INFORMATION WAS PROVIDED BY THE HOSPITAL CONCERNING THE DISCONNECTION OF THE SPIKE. THE RETAIN SAMPLE WAS TESTED AND NO ISSUE WAS NOTED. NO ISSUE HAS BEEN NOTED FOR THIS LOT OF CASSETTES/TUBING SETS IN THE FIELD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12668508 ↗
• MalfunctionOct 20, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  THE THERMACOR 1200 RAPID INFUSION SYSTEM WAS BEING USED AT (B)(6) MEDICAL CENTER FOR A MASS BLOOD TRANSFUSION. DURING THE PROCEDURE, THE HOSPITAL STATED THE CASSETTE STARTED LEAKING FROM THE BOTTOM OF THE CASSETTE. THE HOSPITAL IMMEDIATELY SWITCHED TO PRESSURE BAGS. THE PATIENT WAS TAKEN TO THE OR WHERE A SECOND THERMACOR UNIT WAS USED. DUE TO THE LOCATION OF THE LEAK, IT APPEARS THE HOSPITAL STAFF POSITIONED THE TUBE INCORRECTLY IN THE ROLLER PUMP WHICH CAUSED THE PINCHED TUBING AND LEAKAGE. THE RETAIN SAMPLE WAS TESTED AND NO ISSUE WAS NOTED. NO ISSUE HAS BEEN NOTED FOR THIS LOT OF CASSETTES IN THE FIELD. THE CASSETTE WAS NOT RETURNED BY THE HOSPITAL WHICH NO FURTHER INVESTIGATION COULD BE PERFORMED ON THE LEAKING CASSETTE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12668484 ↗
• MalfunctionDec 9, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  THE THERMACOR 1200 RAPID INFUSION SYSTEM WAS BEING USED AT (B)(6) ON (B)(6) 2020 FOR A MASS TRANSFUSION PROTOCOL. DURING THE PROCEDURE, THE HOSPITAL STATED THE CASSETTE STARTED LEAKING. THE HOSPITAL CONTINUED THE SURGERY BY USING PRESSURE BAGS, AND A RANGER FLUID WARMER. THE SURGERY WAS COMPLETED WITH NO PATIENT HARM, OR INJURY. NO EXTENDED TIME TO SURGERY WAS NOTED BY THE HOSPITAL. THE RETAIN SAMPLE WAS TESTED AND NO ISSUE WAS NOTED. NO ISSUE HAS BEEN NOTED FOR THIS LOT OF CASSETTES IN THE FIELD. THE CASSETTE WAS NOT RETURNED BY THE HOSPITAL, WHICH NO FURTHER INVESTIGATION COULD BE PERFORMED ON THE LEAKING CASSETTE. IT IS UNKNOWN AT THIS TIME WHAT CAUSED THE LEAKING. THIS HAS BEEN AN ISOLATED INCIDENT WITH NO OTHER ISSUES NOTED FROM OTHER HOSPITALS FOR THIS LOT OF CASSETTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10977945 ↗
• MalfunctionNov 19, 2020Misassembly by Users; Misassembly by Users

  THE THERMACOR 1200 INFUSION SYSTEM WAS USED AT (B)(6) HOSPITAL. AFTER 1 1/2 HOURS INTO THE SURGERY, THE HOSPITAL NOTICED THE THERMACOR UNIT WAS NOT INFUSING BLOOD. IT WAS STATED THAT THE LACK OF INFUSION WAS DUE TO THE TWISTED RETURN LINE ON THE CASSETTE. THE CASSETTE WAS CHANGED OUT WITH A SECOND CASSETTE. THE HOSPITAL DID ENCOUNTER PROBLEMS REMOVING THE FIRST CASSETTE DUE TO THE WAY THE INITIAL CASSETTE RETURN LINE HAD BEEN CONNECTED TO THE 3 SPIKE SET. THE FIRST CASSETTE WAS RETURNED FOR INVESTIGATION. IT WAS DETERMINED THAT THE YELLOW LUER LOCK SCREW WAS CONNECTED AND TIGHTENED INCORRECTLY. THE YELLOW LUER LOCK SCREW SHOULD BE USED TO TIGHTEN BUT INSTEAD IT APPEARS THAT THE CLEAR BASE UNDERNEATH WAS TIGHTENED. IT APPEARS THAT THIS INCORRECT TIGHTENING AND TWISTING CAUSED RESTRICTED FLOW. THE RETAIN SAMPLE WAS REVIEWED FOR ANY ISSUE OF THIS TYPE; THE RETAIN SAMPLE WAS TESTED AND NO ISSUE WAS NOTED. THE SURGERY WAS DELAYED SLIGHTLY DUE TO THE CHANGING OF THE CASSETTES; HOWEVER, NO PATIENT INJURY WAS NOTED. NO ISSUE HAS BEEN NOTED FOR THIS LOT OF CASSETTES IN THE FIELD. REVIEWING PAST HISTORY OF COMPLAINTS FOR (B)(6) HOSPITAL, IT WAS NOTED THAT THIS SAME TYPE OF ISSUE WAS NOTED IN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10870096 ↗
• MalfunctionAug 21, 2020Crack; Fluid/Blood Leak

  SETTING UP THE BELMONT FOR RAPID TRANSFUSION OF BLOOD PRODUCTS, THE CASSETTE APPEARED TO BE CRACKED AND LEAKED SALINE AND WAS UNUSABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10436124 ↗
• MalfunctionApr 24, 2020Fluid/Blood Leak; Leak/Splash; Mechanical Problem; Fluid/Blood Leak; Leak/Splash; Mechanical Problem

  THE THERMACOR 1200 INFUSION SYSTEM WAS USED AT (B)(6) ON (B)(6) 2020. THE HOSPITAL NOTICED THE INITIAL CASSETTE HAD A TWISTED RETURN LINE WHICH CAUSED LIMITED FLOW FOR PRIMING. THE DISPOSABLE CASSETTE WAS CHANGED OUT WITH A SECOND CASSETTE. AFTER THE SURGERY WAS COMPLETED, THE HOSPITAL NOTICE THE SECOND CASSETTE WAS LEAKING FROM THE BOTTOM OF THE CASSETTE. BOTH CASSETTES WERE FROM LOT 313923. THE CASSETTE WITH THE KINKED RETURN LINE WAS RETURNED FOR INVESTIGATION. IT WAS DETERMINED THAT THE YELLOW LUER LOCK SCREW WAS TIGHTENED INCORRECTLY. THE YELLOW LUER LOCK SCREW SHOULD BE USED TO TIGHTEN BUT INSTEAD IT APPEARS THAT THE CLEAR BASE UNDERNEATH WAS TIGHTENED. IT APPEARS THAT THIS INCORRECT TIGHTENING CAUSED RESTRICTED FLOW. THE SECOND CASSETTE, CAUSING THE REPORTABLE EVENT, WAS NOT RETURNED FOR INVESTIGATION; HOWEVER, BASED ON THE PICTURES SUBMITTED BY THE HOSPITAL, IT APPEARS THE ROLLER PUMP DOOR TUBING MAY HAVE BEEN PINCHED CAUSING A LEAK AT THAT AREA OF THE CASSETTE. THE SURGERY WAS DELAYED SLIGHTLY DUE TO THE CHANGING OF THE CASSETTES; HOWEVER, NO PATIENT INJURY WAS NOTED. NO ISSUE HAS BEEN NOTED FOR THIS LOT OF CASSETTES IN THE FIELD.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9996503 ↗
• MalfunctionMar 27, 2020Fluid/Blood Leak; Leak/Splash; Mechanical Problem; Fluid/Blood Leak; Leak/Splash; Mechanical Problem

  THE THERMACOR 1200 INFUSION SYSTEM WAS USED AT (B)(6) IN (B)(6) ON (B)(6) 2020. DURING SURGERY, THE HOSPITAL REPORTED THE CASSETTE PATIENT LINE CONNECTOR DETACHED FROM THE CASSETTE PATIENT LINE TUBING AND BLOOD SPILLED FROM THE LINE. THE CASSETTE AND PATIENT LINE WERE REPLACED, AND THE SURGERY WAS COMPLETED. NO PATIENT INJURY OR EXTENDED TIME TO SURGERY WAS NOTED DUE TO THE CHANGING OF THE CASSETTE AND PATIENT LINE. THE CASSETTE AND PATIENT LINE WERE RETURNED TO MEDICAL SOLUTIONS, INC (SMISSON-CARTLEDGE BIOMEDICAL DISTRIBUTOR). THE COMPLAINT WAS CONFIRMED. RETAINS FROM LOT 314412* WERE ALSO REVIEWED; NO ISSUE WAS NOTED WITH THE RETAINS (CASSETTE AND PATIENT LINE). PICTURES OF THE DEFECTIVE CASSETTE AND PATIENT LINE WERE FORWARDED TO THE MANUFACTURER, (B)(6). (B)(6) INVESTIGATED THE COMPLAINT. (B)(6) REVIEWED THE DHR FILE FOR THIS LOT; NO ISSUE WAS NOTED. (B)(6) PERFORMED PULL TESTS ON THE PVC TUBING WITH AND WITHOUT SOLVENT APPLIED TO THE BOND. NO DIFFERENCE WAS NOTED BETWEEN THE TWO TEST SAMPLES. ACCORDING TO (B)(6), THE TENSILE TEST PERFORMED SHOW THAT IT WOULD TAKE A SIGNIFICANT AMOUNT OF FORCE TO SEPARATE THE COMPONENTS WITH OR WITHOUT SOLVENT APPLIED, AND THE PVC TUBE WOULD DE

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9890807 ↗

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-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