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Medline DYNCPDS14Recalls & reported problems

Medline Industries, Inc. · CLEARPRO,CLOSED SXN,14FR,D SWVL,ETT · Class 1

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

Adverse event reports
16
Deaths reported
0
Injuries reported
3
Recalls naming it
1

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10888277703384), received between Apr 29, 2025 and Sep 30, 2026 — classified as 3 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (6 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: 1 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 1 reportsAug 2025: 0 reportsSep 2025: 1 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 1 reportsFeb 2026: 1 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 1 reportsJul 2026: 0 reportsAug 2026: 1 reportsSep 2026: 9 reportsOct 2026: 0 reports2024202520269
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-1855-2022 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Device problems

  • Detachment of Device or Device Component6
  • Break3
  • Loss of or Failure to Bond2
  • Crack1
  • Decrease in Suction1
  • Fracture1
  • Infusion or Flow Problem1
  • Leak/Splash1

Patient problems

  • No Clinical Signs, Symptoms or Conditions13
  • Insufficient Information2
  • Hypoxia1

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

  • MalfunctionSep 30, 2026Detachment of Device or Device Component

    It was reported that "While suctioning, hub of catheter broke off and lodged in vent circuit."

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50946718 ↗
  • MalfunctionSep 25, 2026Break

    It was reported that the device broke where it attaches to the vent circuit.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50902351 ↗
  • MalfunctionSep 21, 2026Break; Detachment of Device or Device Component

    It was reported that "Suction catheter hub broken whilst on vent and during suctioning."

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50842496 ↗
  • MalfunctionSep 21, 2026Break

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50841623 ↗
  • MalfunctionSep 18, 2026Loss of or Failure to Bond; Detachment of Device or Device Component

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50820057 ↗
  • MalfunctionSep 14, 2026Fracture; Detachment of Device or Device Component

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50763579 ↗
  • MalfunctionSep 8, 2026Crack

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50676610 ↗
  • MalfunctionSep 8, 2026Detachment of Device or Device Component

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50673294 ↗
  • MalfunctionSep 8, 2026Loss of or Failure to Bond; Detachment of Device or Device Component

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50671109 ↗
  • MalfunctionAug 28, 2026Retraction Problem

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50498489 ↗
  • MalfunctionJun 1, 2026Loose or Intermittent Connection

    PER THE REPORT, "THE IN-LINE SUCTION CATHETER BREAK AT THE SWIVEL CONNECTION."

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25355975 ↗
  • MalfunctionFeb 18, 2026Material Separation

    ACCORDING TO THE FACILITY, ON (B)(6) 2026, A 14FR IN-LINE SUCTION CATHETER REPORTEDLY CAME APART AT THE ONE-WAY VALVE WHILE THE THERAPIST WAS SUCTIONING A PATIENT WITH AN ETT. THE CLINICIAN STATED THAT THE PATIENT HAD TO BE BAGGED WHILE A NEW CATHETER WAS LOCATED AND PLACED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24382136 ↗
  • MalfunctionJan 28, 2026

    AVANOS IN LINE SUCTION BALLARD CRACKED AT ELBOW. PATIENT CARE NOT COMPROMISED AS BALLARD WAS REPLACED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24199447 ↗
  • InjurySep 12, 2025Leak/Splash; Suction Problem; Leak/Splash; Suction Problem

    ACCORDING TO THE CUSTOMER, ON (B)(6) 2025, "THE PORT TO ATTACH SALINE TO THE DEVICE TO FLUSH THE LINE IS NOT A SNUG FIT, AND THEREFORE SALINE LEAKS ON THE PATIENT" AND THAT THE PROVIDER HAD TO SWITCH TO "OPEN SUCTIONING" DUE TO "LOSS OF PRIMARY FUNCTION WITH LEAKAGE DURING USE" TO "AVERT AIRWAY COMPROMISE."

    Patient problems: Insufficient Information

    MAUDE report 23043028 ↗
  • InjuryJul 31, 2025Unexpected Therapeutic Results; Infusion or Flow Problem; Unexpected Therapeutic Results; Infusion or Flow Problem

    ACCORDING TO THE CUSTOMER REPORT, ON (B)(6) 2025, DURING USE OF THE DEVICE, A SIGNIFICANT LEAK IN THE VENTILATOR CIRCUIT DURING BREATH DELIVERY WAS CREATED. THE PATIENT EXPERIENCED SHORTNESS OF BREATH DUE TO A VENTILATOR LEAK DURING SUCTIONING.

    Patient problems: Hypoxia

    MAUDE report 22674570 ↗
  • InjuryApr 29, 2025Decrease in Suction; Decrease in Suction

    ACCORDING TO THE FACILITY, "THESE CATHETERS HAVE BEEN USED ON MULTIPLE PATIENTS WITH THICK SECRETIONS, AND THE SUCTION DOESN'T FEEL ADEQUATE. WHEN YOU CAN HEAR THE SECRETIONS, BUT THE CATHETER DOESN'T SEEM TO HAVE ADEQUATE SUCTION TO REMOVE THEM".

    Patient problems: Insufficient Information

    MAUDE report 21926930 ↗

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.