SunMed 1-5075-34Recalls & reported problems
Sunmed, LLC · LATEX FREE NASO A/W STER 34FR · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- 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 10889483042915), received between Oct 8, 2024 and Oct 8, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Integrity Problem” (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.
Reports received per month
Most reported problems
Device problems
- Material Integrity Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 8, 2024Material Integrity Problem; Material Integrity Problem
LENGTH WAS MUCH LONGER THAN THE PREVIOUS SUNMED PRODUCT LINE. DISCOVERED UPON PT USE. "NO PTS WERE INJURED"
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20398209 ↗
Other AIRWAY, NASOPHARYNGEAL devices
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- RUSCH IPN042923Teleflex Incorporated · AIRWAY, NASOPHARYNGEAL5 reports
- RUSCH IPN042918Teleflex Incorporated · AIRWAY, NASOPHARYNGEAL2 reports
- RUSCH IPN042921Teleflex Incorporated · AIRWAY, NASOPHARYNGEAL2 reports
- Mallinckrodt 8888247064Covidien LP · AIRWAY, NASOPHARYNGEAL2 reports
- RUSCH IPN042925Teleflex Incorporated · AIRWAY, NASOPHARYNGEAL2 reports
- Curaplex 2021-15028Bound Tree Medical, LLC · AIRWAY, NASOPHARYNGEAL1 report
- RUSCH IPN042213Teleflex Incorporated · 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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