VitaWave VWCA2Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00690103219609), received between Nov 26, 2025 and Dec 24, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (4 reports).

1 other recall cover devices cleared under the same FDA submission (K243781); 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 24, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT, DURING USE, A VITAWAVE CUFF WITH A PC1Q WAS NOT CORRELATING WITH THE BLOOD PRESSURE CUFF. THE FINGER CUFF AND CABLE SET DISPLAYED LOWER THAN NORMAL DIASTOLIC BLOOD PRESSURES. BOTH DEVICES WERE CONNECTED TO A HEMOSPHERE STEAM. THERE WAS NO PATIENT HARM. IT IS UNKNOWN IF THE CUFF OR CABLE CAUSED THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23891147 ↗
• MalfunctionDec 24, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT, DURING USE, A VITAWAVE CUFF HAD INACCURATE READINGS WHILE CONNECTED TO A VITA MONITOR AND PC1Q CABLE IN A EP PFA CASE. THE VITAWAVE PLUS CUFF WAS PLACED ON THE PATIENT'S MIDDLE RIGHT FINGER. THE NON INVASIVE BLOOD PRESSURE CUFF (NIBP) WAS READING SYSTOLIC/DIASTOLIC IN THE 180/110 WHILE THE FINGER CUFF WAS READING LOWER, PARTICULARLY THE DIASTOLIC PRODUCING A MAP THAT WAS 30 MMHG LOWER THAN THE NIPB. THERE WERE MODERATE VASOCONSTRICTION WARNINGS. THE CUFF WAS THEN PLACED ON THE RING FINGER AND RESTARTED. THE PHYSICAL REACHED 60-70 HOWEVER THE SQI WAS 1 BAR FOR SOME TIME. TOWARDS THE END OF THE CASE, THE FINGER CUFF EVENTUALLY CORRELATED BETTER TO THE SYSTOLIC BUT THE DIASTOLIC WAS STILL LOWER WITH THE MAP OFF BY 10-15MMHG. FINGER CUFF WAS NOT PLACED ON THE SAME ARM AS THE NIBP. NIBP CUFF WAS SET TO DO READINGS EVERY 5 THEN 3 DUE TO DISCREPANCY. CLINICIANS TREATED TO THE BRACHIAL ARM CUFF. IT IS UNKNOWN WHETHER ISSUE WAS CAUSED BY THE FINGER CUFF OR PC1Q CABLE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23891135 ↗
• MalfunctionNov 26, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT, DURING INDUCTION, A VITAWAVE PLUS CUFF SHOWED DIFFERENT VALUES COMPARED TO AN ARM CUFF. FINGER CUFF VALUES WERE 146/63 (93) WHILE THE ARM CUFF READ 165/70 (106). AFTER A FEW ARM ADJUSTMENTS WERE MADE AND RECLIPPING THE PC1Q, THE FINGER CUFF VALUES WERE UPDATED TO 118/52 (75) AND THE ARM CUFF VALUES WERE 130/55 (80). PATIENT WAS UNDERGOING A SPINE PROCEDURE. BOTH CUFFS WERE NOT PLACED ON THE SAME ARM. IT IS UNKNOWN WHETHER THE INACCURATE VALUES WERE CAUSED BY THE VITAWAVE PLUS CUFF OR THE PC1Q. THERE WERE NO PATIENT INJURIES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23659709 ↗
• MalfunctionNov 26, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT, DURING INDUCTION AND AFTER STAIRSTEPS, A VITAWAVE PLUS CUFF HAD NO WAVEFORM AND DIFFERENT PRESSURE VALUES COMPARED TO AN A-LINE. READINGS FROM THE VITAWAVE CUFF WAS 188/62 WHILE THE A-LINE READ 144/93. PHYSICIAN SWITCHED FINGERS BUT STILL STRUGGLED TO GET A WAVEFORM. AFTER REINITIALIZING THE PUMP A COUPLE OF TIMES, ISSUE WAS RESOLVED. IT IS UNKNOWN IF THE ISSUE WAS WITH THE FINGER CUFF OR MONITOR. THERE WAS NO PATIENT INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23659487 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K243781. One submission often covers many models, so check the product and lot details in each record.

• Z-3250-2026 · Aug 11, 2026 · Open, Classified
  ForeSight Elite Tissue Oximetry Cable REF HEMFSM10 UDI-DI code: 00690103210927 The non-invasive ForeSight oximeter cable is intended for use as an adjunct monitor of absolute regi