VitaWave VWCARecalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00690103218893), received between Mar 21, 2024 and Mar 21, 2025 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (13 reports).

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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 21, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING USE, THIS VITAWAVE FINGER CUFF, DISPLAYED INACCURATE BLOOD PRESSURE VALUES. THE BLOOD PRESSURE VALUES WERE LOWER THAN EXPECTED. THE PATIENT WAS NOT TREATED FOR THE INACCURATE VALUES. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21664415 ↗
• MalfunctionMar 21, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED A VWCA DISPLAYED INACCURATE BLOOD PRESSURE VALUES DURING AN ELECTIVE KNEE SURGERY THIS ISSUE OCCURRED WHILE TROUBLESHOOTING OF TWO OTHER MALFUNCTIONED VWCA. STAFF EVENTUALLY JUST STOPPED USING THE FINGER CUFFS. THE PATIENT DID NOT RECEIVE TREATMENT FOR THE INACCURATE VALUES. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21664347 ↗
• MalfunctionMar 21, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING USE, THIS VITAWAVE FINGER CUFF, DISPLAYED INACCURATE BLOOD PRESSURE VALUES. THE BLOOD PRESSURE VALUES WERE LOWER THAN EXPECTED. THE PATIENT WAS NOT TREATED FOR THE INACCURATE VALUES. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21663832 ↗
• MalfunctionMar 21, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED A VWCA DISPLAYED INACCURATE BLOOD PRESSURE VALUES DURING AN ELECTIVE KNEE SURGERY. THIS ISSUE OCCURRED WHILE TROUBLESHOOTING OF ANOTHER MALFUNCTIONED VWCA. STAFF USED A THIRD CUFF BUT ISSUE CONTINUED. STAFF EVENTUALLY JUST STOPPED USING THE FINGER CUFFS. THE PATIENT DID NOT RECEIVE TREATMENT FOR THE INACCURATE VALUES. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21663816 ↗
• MalfunctionMar 20, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT A VITAWAVE FINGER CUFF HAD INACCURATE BLOOD PRESSURE VALUES DURING ELECTIVE KNEE SURGERY. THE FINGER CUFF DISPLAYED A BLOOD PRESSURE OF 80S/40S WHILE THE OTHER NON-INVASIVE BLOOD PRESSURE CUFF DISPLAYED VALUES OF 120-130S/70S (90S). BOTH DEVICES WERE PLACED ON THE SAME SIDE OF THE PATIENT. TWO ADDITIONAL VITAWAVE FINGER CUFFS WERE USED FOR TROUBLESHOOTING. STAFF EVENTUALLY JUST STOPPED USING THE FINGER CUFFS. THE PATIENT DID NOT RECEIVE TREATMENT BASED ON THE INACCURATE VALUES. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21660116 ↗
• MalfunctionJan 30, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT MULTIPLE SITES HAD INACCURATE VALUES WHILE USING A VITA WAVE FINGER CUFF ON PATIENTS WITH HIGH BMI. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21277253 ↗
• MalfunctionJan 30, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE NIBP READINGS HAD A VALUE IN THE 150S WHILE THE VITAWAVE FINGER CUFF (VWCA) HAD READINGS IN THE 60S. THE VWCA WAS EXCHANGED AND PLACED ON A DIFFERENT FINGER TO GET A PROPER READING. PROCEDURE DELAYED FOR TROUBLESHOOTING. VWCA WAS CONNECTED TO A VITA MONITOR. THERE WERE NO PATIENT INJURIES. DEVICE IS NOT AVAILABLE FOR RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21276456 ↗
• MalfunctionJan 30, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE NIBP READINGS HAD A VALUE IN THE 130S WHILE THE VITAWAVE FINGER CUFF (VWCA) HAD VALUES IN THE 70S. THE VWCA WAS EXCHANGED AND PLACED ON A DIFFERENT FINGER TO GET A PROPER READING. PROCEDURE DELAYED FOR TROUBLESHOOTING. VWCA WAS CONNECTED TO A VITA MONITOR. THERE WERE NO PATIENT INJURIES. DEVICE IS NOT AVAILABLE FOR RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21276370 ↗
• MalfunctionJan 30, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE NIBP READINGS HAD A VALUE OF 160 WHILE THE VITAWAVE FINGER CUFF (VWCA) HAD READINGS IN THE 60S. THE VWCA WAS EXCHANGED AND PLACED ON A DIFFERENT FINGER TO GET A PROPER READING. PROVIDER TREATED THE CUFF BP WITH A VASOPRESSOR. HOWEVER, PATIENT WAS NORMOTENSIVE AFTER TROUBLESHOOTING. PROCEDURE DELAYED FOR TROUBLESHOOTING. VWCA WAS CONNECTED TO A VITA MONITOR. THERE WERE NO PATIENT INJURIES. DEVICE IS NOT AVAILABLE FOR RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21275757 ↗
• MalfunctionApr 8, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED BY A SALES REP THAT A VWA CUFF WITH LOT NUMBER 65519028 WAS NOT CAPTURING THE BP CORRECTLY DUE TO THE WIDE DISPARITY IN BP READINGS DURING A CASE. CUFF WAS PLACED ON THE PATIENT'S RIGHT RING FINGER AND MAY HAVE BEEN PLACED ON THE SAME ARM AS THE BRACHIAL CUFF. UPON PLACEMENT AND START OF THE MONITORING WITH A PHILLIPS MONITOR, AN ALERT FOR VASOCONSTRICTION ON THE FINGER WAS DISPLAYED ON THE VITA MONITOR. THE VW CUFF PRESSURES WERE READING HIGH 60S AND LOW 70S WHILE THE BRACHIAL CUFF WAS READING IN THE 120S AND 140S FOR SYSTOLIC. WIDE READING DISPARITY BETWEEN THE CUFFS CONTINUED EVEN AFTER MOVING THE CUFF TO THE MIDDLE FINGER AND RECALIBRATING AND ZEROING HRS. THE PATIENT AND STAFF WAS ALREADY DRAPED AND GOWNED, SO THE CLINICIAN ASKED TO STOP MONITORING AND THE DPT OUT CABLE WAS UNPLUGGED FROM THE BEDSIDE MONITOR AND THE HS VITA SYSTEM MONITORING WAS STOPPED. THE SAME VITA MONITOR AND FINGER CUFF FROM THE OR WAS TRANSFERRED TO THE PACU POST CARE TO RECHECK THE PATIENT'S MONITORING. ONCE THE PHILLIPS MONITOR FROM THE OR WAS EXCHANGED TO A MINDRAY MONITOR, THE VALUES MATCHED UP AND THERE WERE NO DISPARITY IN READING. PATIENT WAS A YOUNG FEMALE, HAD A TRUE MEDIUM SIZED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19063557 ↗
• MalfunctionApr 4, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE SYSTOLIC READING ON A VW CUFF, LOT: 65519028, WAS CONSISTENTLY HIGHER THAN A NIBP CUFF DURING A CASE. AT THE RESTART OF CASE, IT WAS AN AVERAGE OF 10 POINTS. DURING AND TOWARDS THE END OF THE CASE, THE SYSTOLIC VALUE OF THE VW CUFF WAS 30 POINTS HIGHER THAN THE NIBP CUFF. IT WAS CONSISTENT IN BOTH PROCEDURES. THE DIASTOLIC VALUES WERE 1 TO 5 POINTS OFF. CORRELATION ON TRENDS WAS GOOD. WAVEFORM TREND OVER TIME BEHAVED AS EXPECTED WHEN THE PATIENT WAS STIMULATED OR MEDICATION WAS GIVEN. NO PATIENT INJURIES. CUFF WAS ATTACHED TO A HEMOSPHERE VITA MONITOR AND NOT RETAINED AFTER CASE. WITHOUT RETURN OF THE UNIT, IT IS NOT POSSIBLE TO DETERMINE IF SOME DAMAGE OR DEFECT EXISTED ON THE UNIT THAT COULD HAVE CONTRIBUTED TO THE EVENT. HOWEVER, AN INVESTIGATION WAS INITIATED TO ASSESS FOR ANY MANUFACTURING RELATED PROCESSES WHICH COULD BE CORRELATED TO THE LOT NUMBER. A SUPPLEMENTAL REPORT WILL BE FORTHCOMING WHEN THE INVESTIGATION IS COMPLETE. COMPLAINT HISTORIES FOR ALL REPORTED EVENTS ARE REVIEWED AGAINST TRENDING CONTROL LIMITS ON A MONTHLY BASIS AND ANY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS A PART OF THE MONTHLY REVIEW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19041818 ↗
• MalfunctionMar 22, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT A VW CUFF HAD INACCURATE READINGS DURING AN ORTHOPEDIC HIP PROCEDURE. UPON MONITORING, VALUES SHOWED WIDE DISPARITY BETWEEN VW CUFF AND BRACHIAL CUFF VALUES. IN THE OR, THE VW CUFF READINGS WERE IN THE 60S FOR SYSTOLIC WHILE BRACHIAL CUFF WAS IN THE 100S. THE PRESSURE READING FOR THE VW CUFF REMAINED LOW DURING THE ENTIRE CASE. DURING POST CASE, THE PATIENT WAS FOLLOWED TO THE PACU. AFTER EXTUBATION, THE FINGER CUFF PRESSURE VALUES WENT UP. WHEN PATIENT WAS AWAKE IN PACU, A LARGE ACUMEN CUFF WAS PUT ON THE PATIENT TO TEST THE PRESSURE VALUES. THE FINGER CUFF READINGS MATCHED THE BRACHIAL CUFF VALUES THAT WERE BEING SEEN DURING THE CASE. IT WAS NOTED THAT THE PATIENT HAS LARGE FINGERS AND THAT DIODES SAT LOW ON THE FINGER. REP REPORTED THAT IT WAS LIKELY THAT THE VW FINGER CUFF WAS PLACED ON THE SAME ARM AS THE BRACHIAL CUFF. VW CUFF WAS USED WITH A HEMOSPHERE VITA MONITOR WITH SERIAL NUMBER (B)(6). CASE LASTED 3 TO 4 HOURS AND OCCURRED ON (B)(6) 2024 AT 0800. NO PATIENT INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18960189 ↗
• MalfunctionMar 21, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT A VW FINGER CUFF HAD INACCURATE VALUES DURING USE. THE PATIENT WAS MONITORED WITH A CUFF THROUGHOUT THE CASE. IT WAS NOTED THAT THE PATIENT HAD VERY LARGE AND LONG FINGERS. DUE TO SUCH LARGE SIZING OF THE FINGERS, STAFF HAD TO PLACE THE CUFF ON THE LEFT HAND PINKY. CUFF WAS PLACED ON THE OPPOSITE ARM FROM THE BRACHIAL CUFF. DUE TO THE PLACEMENT, THE DIODES SAT VERY LOW ON THE FINGER. PULSE OX WAS ALREADY ON RING FINGER. INITIALLY, THERE WAS A LARGE VALUE DISPARITY BETWEEN THE VW CUFF AND BRACHIAL CUFF READINGS. STAFF SWITCHED TO A LARGE CUFF ON THE PINKY TO GET MORE CONSISTENT READINGS. THEY WERE ABLE TO MEASURE THE DIAMETER OF SOME FINGERS POSTCASE. RIGHT HAND INDEX FINGER MEASURED 71.12MM IN DIAMETER. PROCEDURE WAS DONE ON (B)(6) 2024 AT 0730. CUFF WAS USED WITH A HEMOSPHERE VITA MONITOR WITH SERIAL NUMBER: (B)(6). THERE WERE NO PATIENT INJURIES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18956419 ↗