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Curaplex KLTSD404KRecalls & reported problems

Bound Tree Medical, LLC · Airway Supraglottic LTS-D #4 Kit W/ET Holder · Class 1

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 00812277033700), received between May 26, 2020 and May 26, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Nonstandard Device” (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

  • Nonstandard Device1
  • Structural Problem1

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.

  • MalfunctionMay 26, 2020Nonstandard Device; Structural Problem

    EMS SERVICE WAS RESPONDING TO A CARDIAC ARREST CALL AND ATTEMPTED TO USE THE CURAPLEX KIT KLTSD404K TO CARE FOR THE PATIENT, BUT DISCOVERED THE CATHETER TIP OF THE SYRINGE INCLUDED TO INFLATE THE SUPRAGLOTTIC AIRWAY WAS NOT COMPATIBLE WITH THE LUER CONNECTOR OF THE AIRWAY. AS A RESULT, THE EMS SERVICE WAS FORCED TO SEEK OTHER MEASURES TO ESTABLISH AN AIRWAY FOR THE PATIENT. NO INJURIES OR DEATH WERE REPORTED.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10089985 ↗

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