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Medline DYNCPTP14TRecalls & reported problems

Medline Industries, Inc. · CLEARPRO,CLOSED SXN,14FR,T-PC,TRACH · Class 1

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
6
Deaths reported
0
Injuries reported
0
Recalls naming it
1

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10888277703476), received between May 5, 2026 and Sep 28, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Crack” (2 reports).

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

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

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 1 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 3 reportsSep 2026: 2 reportsOct 2026: 0 reports2024202520263
Last 36 months. The most recent month may be incomplete.

Recalls naming this device

  1. Aug 3, 2022Open, Classified

    Potential for the suction catheter to come apart from the green connector near the thumb valve. The connector is coming apart from the assembled device when pulling the catheter out of the artificial airway in the patient suctioning process.

    Z-1857-2022 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Device problems

  • Crack2
  • Break1
  • Connection Problem1
  • Detachment of Device or Device Component1
  • Gas/Air Leak1
  • Leak/Splash1
  • Physical Resistance/Sticking1

Patient problems

  • No Clinical Signs, Symptoms or Conditions6

Recent adverse event reports

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

  • MalfunctionSep 28, 2026Crack

    It was reported that "the product breaking, either cracking or breaking apart."

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50915291 ↗
  • MalfunctionSep 21, 2026Crack

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50846995 ↗
  • MalfunctionAug 19, 2026Detachment of Device or Device Component

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50322356 ↗
  • MalfunctionAug 11, 2026Break; Leak/Splash; Connection Problem

    The report states, "This suction Ballard was in use on a trach patient. The RT found it on a patient with a leak and upon inspection, it broke off."

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50203689 ↗
  • MalfunctionAug 11, 2026Gas/Air Leak

    It was reported that the device was leaking.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50201671 ↗
  • MalfunctionMay 5, 2026Physical Resistance/Sticking

    PER REPORT, "THEY ARE HAVING DIFFICULTY PUTTING THE CATHETER DOWN THE TRACH AND WE ARE ALSO EXPERIENCED THE BALLARD GETTING STUCK ON SUCTION EVEN THOUGH THEY RELEASED THE SUCTION PORT."

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25085704 ↗

Other CATHETERS, SUCTION, TRACHEOBRONCHIAL devices

All CATHETERS, SUCTION, TRACHEOBRONCHIAL devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.