Curaplex 2021-15028Recalls & reported problems
Bound Tree Medical, LLC · Curaplex Nasopharyngeal Airway, Latex-Free, PVC, 28 FR · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- 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 00817617025780), received between Jul 2, 2019 and Jul 2, 2019 — classified as 1 injury.
The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Inadequacy of Device Shape and/or Size1
- Malposition of Device1
- Suction Problem1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 2, 2019Inadequacy of Device Shape and/or Size; Suction Problem; Malposition of Device
I MANAGE QUALITY ASSURANCE FOR THE FIRE DEPARTMENT BASED PARAMEDIC UNITS IN (B)(6). WE HAD A NASOPHARYNGEAL AIRWAY BACKWARDS INTO THE OROPHARYNGEAL SPACE. THE EMS CREW PLACED TWO NASOPHARYNGEAL AIRWAYS ON A CARDIAC ARREST PATIENT (ROUTINE), AND WHEN THEY LATER PLACED A KING AIRWAY, THEY WERE UNABLE TO GET A DEFINITIVE ETC02 READING. THEY THEN PULLED THE KING AND DISCOVERED THE NPA HAD DISPLACED BACKWARD AND WAS BLOCKING THE KING FROM SEALING PROPERLY. THUS IS NOT THE FIRST TIME THIS HAS HAPPENED. THE HOSPITAL CONTACTED THE FIRE DEPARTMENT PREVIOUSLY TO REPORT A SIMILAR INCIDENT ON (B)(6) 2018. (NOTE--THE CASE WAS 8 MONTHS PRIOR AND WE WERE UNAWARE UNTIL THE OTHER CASE WAS REVIEWED). THE ICU STAFF WAS UNABLE TO CLEAR THE PATIENTS GURGLING RESPIRATIONS THROUGH SUCTIONING, AND DISCOVERED A SIMILARLY DISPLACED NPA 10 DAYS AFTER ADMISSION. UPON INVESTIGATION, IT WAS NOTED THAT THE CLEAR CURAPLEX NPAS THAT WE WERE GETTING THROUGH BOUND TREE HAVE A MUCH SMALLER FLANGE THAN PREVIOUS SUPPLIERS. WE ARE PULLING THE CURAPLEX NPAS FROM SERVICE TO THE EXTENT THAT WE HAVE OTHER OPTIONS AVAILABLE. IT IS OUR OPINION THAT THE DISPLACED NPA COULD CONCEIVABLY ENTIRELY OBSTRUCT THE PATIENT'S AIRWAY. FD
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8759793 ↗
Other AIRWAY, NASOPHARYNGEAL devices
- Shiley 8888247015Covidien LP · AIRWAY, NASOPHARYNGEAL7 reports
- RUSCH IPN042923Teleflex Incorporated · AIRWAY, NASOPHARYNGEAL5 reports
- RUSCH IPN042918Teleflex Incorporated · AIRWAY, NASOPHARYNGEAL2 reports
- RUSCH IPN042925Teleflex Incorporated · AIRWAY, NASOPHARYNGEAL2 reports
- Mallinckrodt 8888247064Covidien LP · AIRWAY, NASOPHARYNGEAL2 reports
- RUSCH IPN042921Teleflex Incorporated · AIRWAY, NASOPHARYNGEAL2 reports
- RUSCH IPN042213Teleflex Incorporated · AIRWAY, NASOPHARYNGEAL1 report
- Shiley 8888247031Covidien LP · AIRWAY, NASOPHARYNGEAL1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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