Medline DYNJ18880Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10888277652712), received between Aug 15, 2019 and Dec 2, 2019 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Inflation Problem” (1 report).

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

1 other recall cover devices cleared under the same FDA submission (K110269); 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. Feb 26, 2024Open, Classified

   Complaints have been received that the device inflation tube detached and/or tore from the main tube, resulting in potential moisture buildup, loss of pressure, or inability to inflate. There were also reports the suction pump is difficult to connect or detaches during use.

   Z-1876-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 2, 2019Inflation Problem

  IT WAS REPORTED THAT THE PATIENT REQUIRED RE-INTUBATION AFTER THE ENDOTRACHEAL TUBE BALLOON FAILED TO INFLATE.

  Patient problems: No Code Available; No Information

  MAUDE report 9394947 ↗
• InjuryAug 15, 2019Material Integrity Problem

  IT WAS REPORTED THAT THE ENDOTRACHEAL TUBE HAD A BLOWN CUFF AND A NEW ENDOTRACHEAL TUBE WAS REQUIRED TO BE INSERTED.

  Patient problems: Low Oxygen Saturation

  MAUDE report 8898416 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K110269. One submission often covers many models, so check the product and lot details in each record.

• Z-2243-2016 · Jun 2, 2016 · Terminated
  Parker Trach-Vac Endotracheal Tubes. Tyvek pouches, 10 per box. Product Usage: The product is an endotracheal tube with sub-glottic suction channel to remove secretions. It is use