Portex 101/870/090Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 15019517078022), received between Jun 11, 2026 and Sep 17, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Crack” (4 reports).

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

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2026Crack

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50811293 ↗
• MalfunctionSep 17, 2026Crack

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50810927 ↗
• MalfunctionAug 7, 2026Crack

  It was reported that during patient use with tracheal tube, a crack was noted on the connection to the Suction-aid. There was patient involvement but no harm.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50181019 ↗
• MalfunctionJul 6, 2026Defective Component

  IT WAS STATED THAT THE SUCTION-AID IS DEFECTIVE. THE PATIENT'S ASSISTANTS INFORMED THAT IT WAS NOT POSSIBLE TO USE THE SUCTION-AID. THE PATIENT WAS SCHEDULED FOR A VISIT, AND THE TRACHEOSTOMY TUBE WAS CHANGED WITH AN IDENTICAL TUBE WITH THE SAME LOT. THERE WAS PATIENT INVOLVEMENT, BUT NO INJURY, OTHER THAN HAVING TO COME IN FOR A TUBE CHANGE EARLIER THAN PLANNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25724933 ↗
• MalfunctionJun 12, 2026Crack; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE BLUSELECT SUCTION AID TRACHEOSTOMY TUBE EXHIBITED A DEFECT NEAR THE FLANGE (NECK PLATE) ATTACHMENT POINT, RESULTING IN THE TUBE BECOMING NEARLY DETACHED. A REPLACEMENT TUBE WAS PROVIDED AFTER THE ISSUE WAS IDENTIFIED. ACCORDING TO THE PATIENT'S ASSISTANTS, THE ISSUE WAS NOT ATTRIBUTED TO HANDLING ERROR. THERE WAS PATIENT INVOLVEMENT; HOWEVER, NO INJURY WAS REPORTED. THIS REPORT CAPTURES THE TWO OF TWO OCCURRENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25482048 ↗
• MalfunctionJun 11, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THE BLUSELECT SUCTION AID TRACHEOSTOMY TUBE EXHIBITED A DEFECT NEAR THE FLANGE (NECK PLATE) ATTACHMENT POINT, RESULTING IN THE TUBE BECOMING NEARLY DETACHED. A REPLACEMENT TUBE WAS PROVIDED AFTER THE ISSUE WAS IDENTIFIED. ACCORDING TO THE PATIENT'S ASSISTANTS, THE ISSUE WAS NOT ATTRIBUTED TO HANDLING ERROR. THERE WAS PATIENT INVOLVEMENT; HOWEVER, NO INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25468704 ↗