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VitalPatch 2.0 3037-01Recalls & reported problems

Vital Connect, Inc. · VitalPatch 2.0, 7 days · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00850490007238), received between Aug 31, 2021 and Aug 31, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Biocompatibility” (1 report).

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

Device problems

  • Biocompatibility1

Patient problems

  • Contact Dermatitis1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryAug 31, 2021Biocompatibility; Biocompatibility

    ON (B)(6) 2021, VITALCONNECT WAS CONTACTED BY THE PARENT (MOTHER) OF A (B)(6) YEAR OLD FEMALE PATIENT THAT EXPERIENCED VERY BAD ITCHING AND A REACTION (INCLUDING BLISTERS) TO THE VITALCONNECT VITALPATCH BIOMONITOR. A VITALCONNECT NURSE WAS ABLE TO SPEAK TO THE PARENT ON THE FOLLOWING DAY ((B)(6) 2021). THE PARENT REPORTED THAT HER DAUGHTER HAD THE VITALPATCH PLACED ON (B)(6) 2021 BY HER CARDIAC SPECIALIST AT HIS OFFICE. ON DAY 2 OF THE WEAR, THE PATIENT REPORTEDLY EXPERIENCED MILD ITCHING AROUND THE VITALPATCH. THE PARENT APPLIED BENADRYL CREAM AROUND THE EDGES OF THE PATCH WHICH SEEMED TO RELIEVE THE SYMPTOMS. THIS WAS REPEATED DAILY UNTIL (B)(6) 2021. ON THAT DAY, THE PATIENT COMPLAINED OF INCREASED ITCHING AND REMOVED THE VITALPATCH. THE PATIENT'S SKIN APPEARED VERY RED AND "WATER FILLED BLISTERS" WERE OBSERVED UNDER THE AREAS WHERE THE PATCH ADHESIVE WAS IN CONTACT WITH HER SKIN. THE SKIN WAS GENTLY CLEANSED AND DRIED AND NEOSPORIN WAS APPLIED TO THE BLISTERED AREAS AND COVERED WITH AN ANTIBACTERIAL WOUND DRESSING. THE PATIENT TOOK ONE BENADRYL TABLET ON THE SAME DAY. THE PATIENT'S PARENT DID NOT SEEK MEDICAL ATTENTION FOR HER DAUGHTER BECAUSE SHE "DID NOT FEEL IT WAS NECESSARY

    Patient problems: Contact Dermatitis

    MAUDE report 12396471 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.