ROTEM® delta SystemRecalls & reported problems
Tem Innovations GmbH · The ROTEM® delta is designed for in-vitro diagnostic use by professionals in a laboratory environment. The ROTEM® delta is intended to be used to provide a qualitative and quantitative indication of the coagulation state of a blood sample. For this purpose the ROTEM® delta records the clot firmness changes in a sample of citrated whole blood as the sample clots, retracts and lyses in real time. The analyzer output consists of a qualitative graphical representation (mirrored coagulation curve - clot firmness over time) and several defined numerical parameters describing the curve quantitatively. · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04260160470020), received between Feb 9, 2018 and Aug 31, 2018 — classified as 1 injury, 3 malfunctions.
The most frequently reported specific device problem is “Data Problem” (2 reports).
2 other recalls cover devices cleared under the same FDA submission (K083842); 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 16, 2026.
Most reported problems
Device problems
- Data Problem2
- Fire1
- Installation-Related Problem1
Patient problems
- No Known Impact Or Consequence To Patient4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryAug 31, 2018Installation-Related Problem; Installation-Related Problem
CUSTOMER REPORTED AN ISSUE WITH THEIR ROTEM DELTA. THEY SCANNED THE BARCODE OF A PATIENT'S ID NUMBER WHICH HAD A LETTER Y AT THE END (EG. S1234567Y) BUT THE LAST LETTER FOR THE ID NUMBER THAT SHOWED ON THE ROTEM DELTA WAS Z (EG. S1234567Z). THERE WAS NO PATIENT IMPACT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7838638 ↗MalfunctionMay 16, 2018Fire; Fire
THE CUSTOMER REPORTED THAT THE PIPETTE WOULD NOT CONNECT TO THEIR ROTEM DELTA ANALYZER, EVEN AFTER REBOOTING AND USING THE BACKUP PIPETTE. AN IL FIELD SERVICE ENGINEER WENT ON SITE AND OBSERVED SCORCHED CABLE, BOARD AND CONNECTION OUTLETS POSSIBLY FROM A FIRE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7519474 ↗MalfunctionFeb 9, 2018Data Problem; Data Problem
CUSTOMER REPORTED THAT THE ROTEM MERGED THE DEMOGRAPHIC FROM ONE PATIENT WITH THE RESULT OF ANOTHER PATIENT ON THE REPORT. THE PATIENT RESULTS WERE NOT USED FOR TREATMENT AND NO PATIENT HARM WAS REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7261170 ↗MalfunctionFeb 9, 2018Data Problem; Data Problem
CUSTOMER REPORTED THAT THE ROTEM MERGED THE DEMOGRAPHIC FROM ONE PATIENT WITH THE RESULT OF ANOTHER PATIENT ON THE REPORT. THE PATIENT RESULTS WERE NOT USED FOR TREATMENT AND NO PATIENT HARM WAS REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7261133 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K083842. One submission often covers many models, so check the product and lot details in each record.
- Z-1090-2016 · Feb 18, 2016 · TerminatedROTROL P Control for ROTEM delta Thromboelastometry System, For In Vitro Diagnostic Use Only. Quality control material for monitoring accuracy and precision of test carried out on
- Z-1379-2015 · Oct 23, 2014 · TerminatedROTROL P Control for ROTEM delta Thromboelastometry System, Manufactured for: Tem Innovations GmbH.
Other System, Multipurpose For In Vitro Coagulation Studies devices
- ACL TOP 970 CL 00000280097Instrumentation Laboratory Company · System, Multipurpose For In Vitro Coagulation Studies2 recalls0 reports
- TEG5000 HEMOSTASIS ANALYZER 07-022Haemonetics Corporation · SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES1 recall2 reports
- STA Satellite® 58104Diagnostica Stago · SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES1 recall1 report
- ACL ELITE PRO 00001000311RInstrumentation Laboratory Company · SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES1 recall0 reports
- ACL ELITE PRO 00001000311Instrumentation Laboratory Company · SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES1 recall0 reports
- ACL ELITE 00000880311RInstrumentation Laboratory Company · SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES1 recall0 reports
- ACL ELITE 00000880311Instrumentation Laboratory Company · SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES1 recall0 reports
- Hemochron Whole Blood Microcoagulation System ELITEAccriva Diagnostics Holdings, Inc. · System, Multipurpose For In Vitro Coagulation Studies2 deaths13 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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