CLEARSIGHT CSCSRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00690103193343), received between May 12, 2025 and May 12, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K140312, K160552, K182245); 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 12, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  AS REPORTED DURING USE THE SMALL CLEARSIGHT CUFF WAS PROVIDING INACCURATE VALUES. THE CLEARSIGHT CUFF HAD A DAMPED WAVEFORM AND WAS READING 60S OVER 30S WITH MEAN ARTERIAL PRESSURES OF 40 AND THE NONINVASIVE BLOOD PRESSURE ON THE SAME SIDE WAS READING 110 OVER 80S WITH MAP GREATER THAN 65. THE CLINICIAN REPORTED THAT HE HAD REMOVED THE CLEARSIGHT CUFF TO ADJUST IT BECAUSE THERE SEEMED TO BE A GAP BETWEEN IT AND THE FINGER IT WAS ON. THE PATIENT RECEIVED MEDICATIONS TO INCREASE THE BLOOD PRESSURE BASED ON THE CLEARSIGHT CUFF READINGS. THE CLINICAL SALES REPRESENTATIVE REP STOPPED MONITORING REMOVED THE SMALL CLEARSIGHT CUFF AND REMEASURED THE PATIENT. THE SIZER INDICATED THE PATIENT WAS A MEDIUM CUFF INSTEAD OF A SMALL. WHEN THE CORRECT SIZE CUFF WAS PLACED ON THE PATIENT THE BLOOD PRESSURE VALUES INCREASED TO 100 OVER 60S. THERE WAS NO PATIENT INJURY. THE DEVICE IS AVAILABLE FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22003598 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K140312, K160552, K182245. One submission often covers many models, so check the product and lot details in each record.

• Z-1193-2019 · Mar 21, 2019 · Terminated
  EV1000 Clinical Platform, Models: EV1000A, EV1000NI, EV1000CS Product Usage: EV1000A Monitor is used to optimize fluid management through the use of minimally invasive monitoring
• Z-1732-2015 · May 18, 2015 · Terminated
  ClearSight, Model No. EVHRS Heart Reference Sensor. The EV1000 Clinical Platform Nl and ClearSight finger cuffs noninvasively measures blood pressure and associated hemodynamic pa