BIS 186-0299-RFBRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10884521130180), received between Jan 24, 2024 and Jun 10, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Incorrect Measurement” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K072286); 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 10, 2026Communication or Transmission Problem; Temperature Problem; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE DEVICE WAS NOT RECOGNIZED BY THE MONITOR, AND THE DEVICE WIRE WAS PEELED. THERE WAS NO REPORTED PATIENT INVOLVEMENT OR ADVERSE OUTCOME. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND THAT THE PRINTED CIRCUIT BOARD SMELLED LIKE BURNING.

  Patient problems: Insufficient Information

  MAUDE report 25457410 ↗
• MalfunctionJan 26, 2026Device Alarm System; Image Display Error/Artifact; Use of Device Problem

  IT WAS REPORTED THAT THE UNIT FAILED TO RECOGNIZE PIC (PATIENT INTERFACE CABLE), AS THE DEVICE CONTINUED TO DISPLAY 'PLEASE CONNECT PIC' DESPITE THE CONNECTION OF KNOWN GOOD CABLES AND THERE WAS NO ALARM. TRIED DIFFERENT KNOWN GOOD CABLE AND MODULE BUT STILL THE SAME. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24177341 ↗
• MalfunctionMay 1, 2024Incorrect Measurement; Incorrect Measurement

  ACCORDING TO THE REPORTER, THE MONITOR HAD NO RELIABLE READINGS. THERE WAS NO REPORTED PATIENT INVOLVEMENT OR OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 19221185 ↗
• MalfunctionJan 24, 2024Incorrect Measurement; Incorrect Measurement

  ACCORDING TO THE REPORTER, THE UNIT DID NOT HAVE REAL DATA. THERE WAS NO REPORTED PATIENT INVOLVEMENT AND OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 18575199 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K072286. One submission often covers many models, so check the product and lot details in each record.

• Z-2958-2018 · Jul 26, 2018 · Open, Classified
  Li-ion battery packs used in BIS Vista and BIS View Monitoring Systems. Product Number/CFN: 186-0208 UDI-Device Identifier (GTIN/UPN): 10884521130319