Shiley 5UN70RRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884521205499), received between Apr 29, 2021 and Jun 30, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (2 reports).

1 FDA recall record name this device's identifier, 1 still open.

1 other recall cover devices cleared under the same FDA submission (K150844); they may or may not involve this specific model.

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 16, 2026.

Recalls naming this device

1. Mar 24, 2023Open, Classified

   A manufacturing error, resulted in a less than specified diameter of adult flexible tracheostomy tube connectors, which results in unsecure connections with 15mm caps and other 15mm circuit components and accessories. An unsecure connection could lead to respiratory failure, dyspnea, treatment delay, tissue injury, or bleeding.

   Z-1357-2023 · Root cause: Component change control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 30, 2026Crack

  IT WAS REPORTED THAT DURING PRE-USAGE INSPECTION, AFTER OPENING THE 2 BOXES OF THE TRACH TUBES EACH INNER CANNULA HAD CRACKS. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25667817 ↗
• MalfunctionApr 29, 2021Disconnection; Use of Device Problem; Disconnection; Use of Device Problem

  ACCORDING TO THE REPORTER, DURING NORMAL MAINTENANCE OF TRACH AT HOME, THE DEVICE HAD A BROKEN FLANGE. IT WAS TORN AND SPLIT. IT WAS REPORTED THAT THE PATIENT DESCRIBED IT AS PLASTIC FATIGUE AND COULD NO LONGER HOLD THE TRACH TIED INTO STOMA. A NEW TRACH WAS INSTALLED. THERE WAS NO PATIENT INJURY.

  Patient problems: Unintended Extubation

  MAUDE report 11749438 ↗
• MalfunctionApr 29, 2021Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE DEVICE HAD A BROKEN FLANGE. IT WAS TORN AND SPLIT. THE FLANGE AT TOP OF THE TRACK THAT ENCIRCLES IT WAS PULLED APART FROM THE DEVICE ITSELF AND TIES COULD NO LONGER HOLD IT INTO STOMA. THE LEFT SIDE FLANGE WAS PULLED AWAY FROM THE TUBE THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11749338 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K150844. One submission often covers many models, so check the product and lot details in each record.

• Z-1390-2025 · Feb 26, 2025 · Open, Classified
  Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff Reusable Inner Cannula, REF: 7CN80R