STA-R Evolution® Expert Series 58978Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 03607450589788), received between Jun 8, 2017 and Aug 14, 2020 — classified as 1 death, 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 reports).

1 other recall cover devices cleared under the same FDA submission (K082675, K093001, K983460); 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

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryAug 14, 2020Incorrect Measurement; Low Test Results; Incorrect Measurement; Low Test Results

  THE LABORATORY OBSERVED THAT SEVERAL PATIENT SAMPLES HAD RESULTED LOW (IN THE 20'S) FOR THE PTT TEST. THE QUALITY CONTROL VALUES BEFORE THESE POTENTIALLY ERRONEOUS RESULTS WERE WITHIN THE ESTABLISHED RANGES. QC WERE NOT DONE AFTER THE ERRONEOUS RESULTS; THE UNIT WAS TAKEN OUT OF SERVICE. THE SAMPLES WERE RERUN ON THE ALTERNATE UNIT; FOUR SAMPLES FAILED RERUN CRITERIA. FOUR CORRECTED REPORTS WERE GENERATED. ONE PATIENT WAS TREATED BASED ON THE ORIGINAL INCORRECT RESULT (37 SECONDS), KNOWING THAT THIS PATIENT HAD AN INITIAL RESULT UPON ADMISSION OF 36 SECONDS. THE PATIENT RECEIVED A BOLUS OF HEPARIN TO GET THE PTT INTO THE THERAPEUTIC RANGE OF 60 - 85 SECONDS. THE PATIENT DEVELOPED A NOSEBLEED. IN THE MEANTIME, THE ORIGINAL SAMPLE WAS RERUN ON THEIR OTHER ANALYZER AND RESULTED AS 51 SECONDS. THE OTHER THREE PATIENTS WERE NOT IMPACTED BY THE ERRONEOUS RESULTS.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 10407662 ↗
• InjuryJan 16, 2020Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available; Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available

  ON (B)(6) 2019, THE CUSTOMER REPORTED SIX ERRONEOUS PTT RESULTS HAD BEEN PRODUCED AND RELEASED. QC RESULTS WERE WITHIN RANGE BEFORE AND AFTER THE ERRONEOUS RESULTS WERE PRODUCED. THE CUSTOMER LATER INDICATED (QUESTIONNAIRE DATED (B)(6) 2019) THAT THERE WERE FIVE PATIENTS INVOLVED, AND STATED THAT THERE WERE NO LIFE-THREATENING OR PERMANENT EFFECTS ON THE PATIENTS. AT LEAST ONE OF THE PATIENTS DID RECEIVE HEPARIN THERAPY BASED ON THE ERRONEOUS RESULTS. CORPORATE COMPLAINT FILE: (B)(4). IMPORTER COMPLAINT FILE: (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9595990 ↗
• InjuryJan 16, 2020Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available; Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available

  ON (B)(6) 2019, THE CUSTOMER REPORTED SIX ERRONEOUS PTT RESULTS HAD BEEN PRODUCED AND RELEASED. QC RESULTS WERE WITHIN RANGE BEFORE AND AFTER THE ERRONEOUS RESULTS WERE PRODUCED. THE CUSTOMER LATER INDICATED (QUESTIONNAIRE DATED (B)(6) 2019) THAT THERE WERE FIVE PATIENTS INVOLVED, AND STATED THAT THERE WERE NO LIFE-THREATENING OR PERMANENT EFFECTS ON THE PATIENTS. AT LEAST ONE OF THE PATIENTS DID RECEIVE HEPARIN THERAPY BASED ON THE ERRONEOUS RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9595574 ↗
• DeathAug 10, 2017Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  ON (B)(6) 2017, DIAGNOSTICA STAGO INC. BECAME AWARE OF A DEATH AT (B)(6). THE FEMALE PATIENT EXPIRED ON OR ABOUT (B)(6) 2017. THE PATIENT'S PT, PTT, AND D-DIMER WERE TESTED USING THE STAGO ANALYZER [STA-R EVOLUTION, SERIAL NUMBER (B)(4)]. AT THIS TIME THERE IS NO EVIDENCE OF AN INSTRUMENT MALFUNCTION, NOR IS THERE A CLEAR CONNECTION BETWEEN THE PATIENT'S DEATH AND THE STAGO TESTING. THE INVESTIGATION IS CONTINUING; FULL DETAILS AND ADDITIONAL DATA ARE STILL BEING RECEIVED BY THE DESIGNATED COMPLAINT HANDLING UNIT. A SUPPLEMENTARY/ FOLLOW-UP REPORT (OR REPORTS) WILL BE SUBMITTED AS PERTINENT INFORMATION BECOMES AVAILABLE. THE INVESTIGATION FILE IS BEING DOCUMENTED UNDER REFERENCE NUMBER (B)(4).

  Patient problems: Death; Pulmonary Embolism

  MAUDE report 6785114 ↗
• MalfunctionJun 8, 2017Incorrect Or Inadequate Test Results; Incorrect Or Inadequate Test Results

  ON (B)(6) 2017, THE ACCOUNT CALLED THE DIAGNOSTICA STAGO HOTLINE TO REPORT THREE ERRONEOUS RESULTS. AMONG THESE THREE RESULTS, ONLY THE TWO FOLLOWING HAVE BEEN DETAILED: SAMPLE 1 ((B)(6) 2017): ORIGINAL RESULTS: PT = 31.6 SEC WITH INR = 3.11; REPEATED: PT = 12.9 SEC WITH INR = 1.1. SAMPLE 2 ((B)(6) 2017): ORIGINAL RESULTS: APTT = 37.6 SEC; REPEATED: APTT = 26.8 SEC. THE CUSTOMER QUESTIONED THE RESULTS AND RERAN THE SAMPLES ON ANOTHER STAGO INSTRUMENT. THE RESULTS WERE THEN AS THE CUSTOMER EXPECTED. THE QUALITY CONTROL (QC) RESULTS BEFORE AND AFTER THE ERRONEOUS RESULTS WERE FOUND WITHIN THE DEFINED RANGE. ON (B)(6) 2017 THE ACCOUNT CLARIFIED TO THE HOTLINE THAT THE TWO CONCERNED PATIENTS HAD THEIR REPORTS AMENDED. THE ACCOUNT STATED IN WRITING THAT PATIENTS WERE NOT TREATED AND THEREFORE UNINJURED. THE SAME DAY, THE FSE ARRIVED ON SITE AND NOTICED THAT THE NEEDLE WAS SOMETIMES HITTING THE TUBE CAPS. UPON CHECKING THE MAPPING, ARM #1 STOPPED WORKING. TO RESOLVE THE ISSUE, THE FSE REPLACED THE X, Y, AND Z MOTORS, BOTH ARM CIRCUIT BOARDS, AND THE MAIN RACK MULTIFUNCTION CIRCUIT BOARD. THE SYSTEM WAS RESTORED TO STAGO SPECIFICATIONS THAT DAY. IT IS IMPORTANT TO NOTE THAT THE ENGINEER M

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6621426 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K082675, K093001, K983460. One submission often covers many models, so check the product and lot details in each record.

• Z-0899-03 · Mar 5, 2003 · Terminated
  STA-Compact Hemostasis System with Cap piercing capability.