Smart Pressure Controller PC1QRecalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00690103219395), received between Nov 7, 2025 and Sep 29, 2026 — classified as 21 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (20 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50933737 ↗
• MalfunctionSep 29, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50933710 ↗
• MalfunctionSep 29, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50933679 ↗
• MalfunctionSep 29, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50933669 ↗
• MalfunctionSep 29, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50926718 ↗
• MalfunctionSep 28, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50926501 ↗
• MalfunctionSep 28, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50926499 ↗
• MalfunctionSep 28, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50926492 ↗
• MalfunctionSep 28, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50926487 ↗
• MalfunctionSep 28, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50926483 ↗
• MalfunctionSep 28, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50926467 ↗
• MalfunctionSep 28, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50926362 ↗
• MalfunctionSep 28, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50924275 ↗
• MalfunctionSep 28, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50924263 ↗
• MalfunctionJan 15, 2026Incorrect, Inadequate or Imprecise Result or Readings

  AS REPORTED DURING USE IN A HEMOSPHERE STREAM TMR THE SMART PRESSURE CONTROLLER WAS NOT CORRELATING WITH THE BLOOD PRESSURE CUFF VALUES. NO ADDITIONAL INFORMATION WAS AVAILABLE. THERE WAS NO PATIENT INJURY. IT IS UNKNOWN IF THE DEVICE WILL BE AVAILABLE FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24080776 ↗
• 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23891222 ↗
• MalfunctionDec 24, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT, DURING USE, A HEMOSPHERE STREAM MODULE WITH A PC1Q HAD A PERFORMANCE DISCREPANCY COMPARED TO A VITA MONITOR. AT THE START OF THE CASE, THE STREAM MODULE WITH PC1Q HAD A READING OF 67/43 (51), THE VITA MONITOR WITH PC2K HAD A READING OF 60/46 (52) AND THE NON-INVASIVE BLOOD PRESSURE CUFF (NIBP) HAD A READING OF 89/66 (74). AFTER 10 MINUTES, THE TABLE WAS RAISED AND THE PROCEDURE STARTED. AT THIS TIME, THE STREAM MODULE WITH PC1Q HAD A READING OF 94/53 (70), THE VITA MONITOR WITH PC2K HAD A READING OF 105/64 (83) AND THE NON-INVASIVE BLOOD PRESSURE CUFF (NIBP) HAD A READING OF 127/90 (99). THE HS STREAM CONTINUED TO SHOW A MAP DIFFERENCE OF 18 TO 20 MMHG COMPARED TO THE VITA THROUGHOUT THE CASE WHILE THE VITA MONITOR TRENDED CLOSER TO THE NIBP. NIBP WAS CONSISTENT THROUGHOUT THE ENTIRE CASE. STREAM SQI WAS BETWEEN 3 TO 4 AND THE VITA WAS 4. THE VITA MONITOR WAS SET UP ON THE RIGHT INDEX FINGER WITH THE HRS CLIP AT ABOUT 4 INCHES. THE STREAM MONITOR WAS PLACED ON THE RIGHT RINGER FINGER. PHYSICIAN TREATED TO THE VITA MONITOR AND NIBP. DUE TO THE VALUE DIFFERENCE, THE CLINICIAN DID NOT TRUST THE STREAM MODULE WITH PC1Q. IT WAS NOTED THAT THE PATIENT'S HAND APPEARE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23891208 ↗
• MalfunctionNov 26, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT, DURING INDUCTION, A PC1Q WHILE CONNECTED TO A VITAWAVE PLUS CUFF SHOWED DIFFERENT VALUES COMPARED TO AN ARM CUFF. INITIALLY, THE 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 23660277 ↗
• MalfunctionNov 7, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  AS REPORTED DURING USE THE SMART PRESSURE CONTROLLER PRESSURE VALUES OF 146/63 (93) WERE DIFFERENT FROM THE A-LINE VALUES OF 165/70 (106) DURING INDUCTION. THERE WAS NO PATIENT INJURY. THE DEVICE IS NOT AVAILABLE FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23499114 ↗
• MalfunctionNov 7, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  AS REPORTED DURING USE THE SMART PRESSURE CONTROLLER PRESSURE VALUES WERE OFF BY 40MMHG FROM THE A-LINE (188/86 VWCA2; 144/93 A-LINE). THEY ALSO FAILED TO GET A WAVEFORM AFTER STAIRSTEPS DURING INDUCTION. THEY SWITCHED FINGERS AND STRUGGLED TO GET A WAVEFORM. AFTER LETTING THE PUMP REINITIALIZE A COUPLE TIMES IT THEN WORKED. THERE WAS NO PATIENT INJURY. THE DEVICE IS NOT AVAILABLE FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23499021 ↗
• MalfunctionNov 7, 2025Incorrect Measurement; Incorrect Measurement

  AS REPORTED, IN THIS TARGET MARKET RELEASE (TMR), FOLLOWING PATIENT INTUBATION, THIS SMART PRESSURE CONTROLLER CABLE PROVIDED A SLIGHT DISCREPANCY IN BLOOD PRESSURE (BP) OF 20MM HG COMPARED TO THE BRACHIAL CUFF, WHICH WAS PLACED ON THE SAME ARM (RIGHT). ONCE THE PATIENT WAS ON THE TABLE, THE FINGER CUFF WAS MOVED TO THE LEFT ARM, AND AFTER A WHILE, VALUES MATCHED UP THE VALUES PROVIDED BY THE BRACHIAL CUFF. NO ERROR MESSAGE WAS DISPLAYED. THE PATIENT WAS NOT TREATED ACCORDING TO INCORRECT VALUES. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE WAS NOT AVAILABLE FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23494801 ↗

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