CLEARSIGHT CSCMRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00690103193350), received between Jan 7, 2025 and Jan 7, 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 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.

• MalfunctionJan 7, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THERE WAS A FAILURE WITH ONE CLEARSIGHT CUFF. THERE WERE INACCURATE READINGS DURING USE WITH THE CUFF. THE NON-INVASIVE BLOOD PRESSURE CUFF WAS BEING USED ALONG WITH THE CLEARSIGHT CUFF. THE READING FROM THE CLEARSIGHT CUFF WAS 20 TO 30MMHG LOWER THAN THE MEAN ARTERIAL PRESSURE READING FROM THE NON-INVASIVE BLOOD PRESSURE CUFF. THE CLINICIANS PLACED THE CLEARSIGHT CUFF IN A DIFFERENT LOCATION ON THE PATIENT, BUT THERE WAS STILL THE 20 - 30MMHG DIFFERENCE BETWEEN THE TWO TECHNOLOGIES. THE PATIENT'S HANDS WERE WARM AND THE CAPILLARY REFILL WAS BRISK ON BOTH SIDES. THERE WAS NO INAPPROPRIATE PATIENT TREATMENT ADMINISTERED. THERE WAS NO PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21096580 ↗

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 monitori
• 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