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iLINK-BIS-10Recalls & reported problems

Oscor Inc. · Class 2 · Implant

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00836559004745), received between Mar 26, 2020 and Mar 26, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “High impedance” (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

  • High impedance1

Patient problems

  • No Consequences Or Impact To Patient1

Recent adverse event reports

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

  • MalfunctionMar 26, 2020High impedance; High impedance

    IT WAS REPORTED THAT ADAPTOR SHOWS HIGH IMPEDANCE WHEN TRIED TO CONNECT CRT-D PLATINIUM 1811. ADAPTOR WAS DISCONNECTED AND CONNECTED AGAIN TO BOTH LEADS BUT STILL HIGH IMPEDANCE WAS NOTICED. PATIENT OUTCOME IS STABLE. THE ADAPTOR WAS POSITIONED AT THE POCKET TOGETHER WITH OTHER ELECTRODES AND DEVICE. THE ADAPTOR WAS USED TO CONNECT THE TWO LEFT VENTRICLE ELECTRODES TO THE CRM SYSTEM. ADAPTOR WAS REPLACED WITH ANOTHER OSCOR BRANDED ADAPTOR WHICH IS WORKING PROPERLY WITH GOOD VALUES. NO OTHER INFORMATION IS AVAILABLE.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9887113 ↗

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