ThermaCor 1200 Infusion System DC-1200Recalls & reported problems
Smisson-Cartledge Biomedical, LLC · Cassette · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00857893006080), received between Nov 6, 2020 and Nov 6, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Failure to Infuse” (1 report).
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
Device problems
- Failure to Infuse1
- Physical Resistance/Sticking1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 6, 2020Failure to Infuse; Physical Resistance/Sticking
CALLED TO ROOM AS THERMACORE WAS NOT INFUSING BLOOD. UNABLE TO FIX THE PROBLEM. BLOOD WAS GIVEN MANUALLY WITH A SYRINGE. WHEN ATTEMPTING TO REMOVE THERMACORE TUBING SETUP THE CASSETTE STUCK AND DIFFICULT TO REMOVE. AFTER MULTIPLE ATTEMPTS WAS ABLE TO GET CASSETTE REMOVED. NEW SETUP WAS PLACED AND PRIMED AND BLOOD WAS ABLE TO BE TRANSFUSED USING THERMACORE. THIS WAS A SIGNIFICANT DELAY IN BLOOD ADMINISTRATION FOR A CRITICALLY ILL PATIENT REQUIRING MULTIPLE UNITS OF BLOOD." MANUFACTURER RESPONSE FOR WARMER, THERMAL, INFUSION FLUID, THERMACOR 1200 INFUSION SYSTEM (PER SITE REPORTER). NO RESPONSE YET.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10800431 ↗
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-1258-2021 · Feb 18, 2021 · TerminatedThermaCor 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 · TerminatedThermaCor 1200 Disposable Sets Components of the Smisson-Cartledge Biomedical ThermaCor 1200 Rapid Thermal Infusion System, used for infusion of: -crystalloid, colloid, or blood
- Z-1260-2021 · Feb 18, 2021 · TerminatedThermaCor 1200 Disposable Sets Components of the Smisson-Cartledge Biomedical ThermaCor 1200 Rapid Thermal Infusion System, used for infusion of: -crystalloid, colloid, or blood
Other Warmer, thermal, infusion fluid devices
- Level 1 HL-90Icu Medical, Inc. · Warmer, thermal, infusion fluid991 reports
- Level 1 HL-390Icu Medical, Inc. · Warmer, thermal, infusion fluid634 reports
- Level 1 L-70Icu Medical, Inc. · Warmer, thermal, infusion fluid1 recall385 reports
- 3-Spike Disposable Set (1 Piece) 903-00006PBelmont Instrument Corporation · Warmer, Thermal, Infusion Fluid1 recall1 death97 reports
- Rapid Infuser RI-2, 120V, 750 ml/min 903-00039Belmont Instrument Corporation · Warmer, Thermal, Infusion Fluid132 reports
- Level 1 L-70NIIcu Medical, Inc. · Warmer, thermal, infusion fluid114 reports
- Rapid Infuser RI-2, 120V, 1000ml/min 903-00037Belmont Instrument Corporation · Warmer, Thermal, Infusion Fluid1 death76 reports
- Hyperthermia Pump Procedure Kit 902-00045Belmont Instrument Corporation · Warmer, Thermal, Infusion Fluid1 recall4 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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