MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP - NAMIC MEDLINE; LHK CENTRAL FLORIDA CARDIO

Catalog Number	VASC1459
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Update to h6: investigation findings.Update to h6: investigation conclusions.Update to h7: remedial action initiated.Update to h9: recall number.
Additional Manufacturer Narrative
It was reported that "the control syringe rotates off the end of the manifold when aspirating/injecting fluids" on (b)(6) 2026.The customer reported that there was no patient involvement and that an additional control syringe was utilized to complete the procedure.To date, no information has been received to indicate that a user or a patient experienced a death, serious injury, medical intervention, or follow-up care associated with the reported problem/issue.In an abundance of caution, and in response to an fda 483 issued for cfn 1417592 on 22-jan-2024, this medwatch is being filed for the reported problem/issue.If additional relevant information becomes available a supplemental medwatch will be filed.
Event or Problem Description
It was reported that "the control syringe rotates off the end of the manifold when aspirating/injecting fluids" on (b)(6) 2026.The customer reported that there was no patient involvement and that an additional control syringe was utilized to complete the procedure.

• Brand Name: MEDLINE
• Common Device Name: LHK CENTRAL FLORIDA CARDIO
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP - NAMIC; 10 glens falls technical park; glens falls NY 12801 3864
• Manufacturer Contact: danielle pohlman ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 24654843
• Report Number: 3015910259-2026-00089
• Device Sequence Number: 5676915
• Product Code: OEZ
• UDI-Device Identifier: 10195327509781
• UDI-Public: 10195327509781
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: VASC1459
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2026
• Supplement Date Received by Manufacturer: 03/12/2026
• Initial Report FDA Received Date: 03/20/2026
• Supplement Report FDA Received Date: 04/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 26-025-FGX1
• Patient Sequence Number: 1
• Patient Sex: Unknown