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Medline Industries, Inc. VASC1324Recalls & reported problems

Medline Industries, Inc. · LHK- LEFT HEART KIT BAPTIST · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
3
Deaths reported
0
Injuries reported
0
Recalls naming it
2

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10195327126773), received between Jul 21, 2025 and Jul 21, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Connection Problem” (3 reports).

2 FDA recall records name this device's identifier, 2 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 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: 3 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: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520263
Last 36 months. The most recent month may be incomplete.

Recalls naming this device

  1. Feb 27, 2026Class IOpen, Classified

    Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.

    Z-1718-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

  2. Feb 25, 2026Class IIOpen, Classified

    The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.

    Z-1836-2026 · Root cause: No Marketing Application · Recall details · FDA record ↗

Most reported problems

Device problems

  • Connection Problem3

Patient problems

  • No Clinical Signs, Symptoms or Conditions3

Recent adverse event reports

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

  • MalfunctionJul 21, 2025Connection Problem; Connection Problem

    ACCORDING TO THE FACILITY, "SYRINGE CONTROL 10 ML WOULD NOT TIGHTEN."

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22560149 ↗
  • MalfunctionJul 21, 2025Connection Problem; Connection Problem

    SYRINGE WOULD NOT TIGHTEN.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22554901 ↗
  • MalfunctionJul 21, 2025Connection Problem; Connection Problem

    ACCORDING TO THE FACILITY, "SYRINGE CONTROL 10 ML WOULD NOT TIGHTEN".

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22553897 ↗

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Sources and updates

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