Multi-Link™ 2090101-110Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10190752138155), received between Mar 16, 2023 and Jun 16, 2023 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (2 reports).

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.

• MalfunctionJun 16, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE TELEMETRY BOX DOES NOT READ PROPERLY ON PATIENTS.THERE WAS NO PATIENT HARM ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17145063 ↗
• MalfunctionJun 16, 2023Device Alarm System; Device Alarm System

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THERE IS NO TELEMETRY ALERT ON THE PATIENT MONITOR. AT THIS TIME, THE CUSTOMER HAS NOT PROVIDED ANY INFORMATION REGARDING PATIENT HARM OR INJURY ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17144838 ↗
• InjuryMay 30, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED TO (B)(4) MEDICAL THAT THE TELEMETRY BOX DOES NOT READ PROPERLY ON PATIENTS. THE TELEMETRY BOX WILL NOT PICKUP OR READ ASYSTOLE ON A PATIENT WHO HAS A CARDIAC RHYTHM. THE STAFF STATED THAT THEY SWITCHED OUT THIS DEVICE WITH ANOTHER AND ISSUE DID NOT RE OCCUR. AT THIS TIME, THE CUSTOMER HAS NOT PROVIDED ANY INFORMATION REGARDING PATIENT HARM OR INJURY ASSOCIATED WITH THE REPORTED EVENT. THE STAFF STATED THAT THEY SWITCHED OUT THIS DEVICE WITH ANOTHER AND ISSUE DID NOT REOCCUR. WHEN THIS PDM WAS CONNECTED TO A MONITOR FOR TESTING IN THE SHOP, IT ALARMED "CUFF LOOSE" AS PATIENT WAS NOT DISCHARGED BEFORE IT WAS REMOVED FROM THE MONITOR ON THE UNIT. THE CUSTOMER PERFORMED NIBP MEASUREMENT USING CALIBRATED TEST EQUIPMENT AND COULD NOT REPRODUCE THE CUSTOMER REPORTED PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17020989 ↗
• MalfunctionMar 16, 2023Failure to Transmit Record; Failure to Transmit Record

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE 2090101-110 - TELE ADAPTER X2, 5/6-LEAD FOR APEXPRO FH WOULD NOT TRANSMIT PATIENT DATA. THERE'S ALSO A PATIENT HOOKED UP IN THE DEVICE. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT HARM OR INJURY ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16555081 ↗