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NA ADAP-2000Recalls & reported problems

Remington Medical, Inc. · Disposable Adapter · Class 2

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 00813079021230), received between Oct 30, 2019 and Oct 30, 2019 — classified as 1 malfunction.

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

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Cardiopulmonary Arrest1
  • Complete Heart Block1

Recent adverse event reports

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

  • MalfunctionOct 30, 2019Adverse Event Without Identified Device or Use Problem

    THE FOLLOWING WAS REPORTED TO REMINGTON MEDICAL ON (B)(6) 2019: WHILE PREPARING TO PLACE A PERMANENT PACEMAKER WE [DEVICE USER] WAS PLACING THE TEMPORARY PACEMAKER TO USE AS BACKUP DURING THE PROCEDURE. AS WE [DEVICE USER] WERE PREPARING TO PLACE THE TEMPORARY PACEMAKER THE PATIENT WENT INTO ASYSTOLE AND THEN 3 DEG HEART BLOCK. THE TEMP PACE WAS PLACED BUT DID NOT WORK. A CODE BLUE WAS CALLED AND THE PATIENT HAD CHEST COMPRESSIONS AND WAS INTUBATED. ANOTHER TEMPORARY PACEMAKER AND CABLES WAS OPENED AND PLACED AND WAS ABLE TO PACE.

    Patient problems: Cardiopulmonary Arrest; Complete Heart Block

    MAUDE report 9255774 ↗

Other CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR) devices

All CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR) devices →

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