MAUDE Adverse Event Report: MEDLINE INDUSTIRES, LP- NAMIC MEDLINE; MTS,LEFT HEART,KIT,VIDANT MED CTR

Catalog Number	601604710
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
According to the facility, on (b)(6) 2026, the control syringe was backing off the manifold during procedures.Customer reports this is a safety concern for air leaks.The manifold was replaced and the same issue occurred.The facility reports no injuries occurred no medical treatment was needed.No additional information at this time.To date, no information has been received to indicate that a user or a patient experienced a death, serious injury, medical intervention, follow-up care, or other adverse health impact 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
According to the facility, on (b)(6) 2026, the control syringe was backing off the manifold during procedures.The manifold was replaced and the same issue occurred.
Additional Manufacturer Narrative
Update to b5: addition of transeptal procedure in left atrium to narrative.Updated h6: type of investigation (b).Updated h6: investigation findings (c).Updated h6: investigation conclusions (d).According to the facility, on 2/9/2026, the control syringe was backing off the manifold during procedures.Customer reports this is a safety concern for air leaks with these coming lose or off during transeptal procedures in the left atrium.The manifold was replaced and the same issue occurred.The facility reports no injuries occurred and no medical treatment was needed.No additional information at this time.To date, no information has been received to indicate that a user or a patient experienced a death, serious injury, medical intervention, follow-up care, or other adverse health impact 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
According to the facility, on 2/9/2026, the control syringe was backing off the manifold during procedures.Customer reports this is a safety concern for air leaks with these coming lose or off during transeptal procedures in the left atrium.The manifold was replaced and the same issue occurred.The facility reports no injuries occurred and no medical treatment was needed.No additional information at this time.

• Brand Name: MEDLINE
• Common Device Name: MTS,LEFT HEART,KIT,VIDANT MED CTR
• Manufacturer (Section D): MEDLINE INDUSTIRES, LP- NAMIC; 10 glen falls technical park; technical park drive; glen falls NY 12801 3864
• Manufacturer Contact: alyssa reasner ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 24533463
• Report Number: 3015910259-2026-00076
• Device Sequence Number: 10350500
• Product Code: OEZ
• UDI-Device Identifier: 10193489071795
• UDI-Public: 10193489071795
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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,Company Representative
• Initial Reporter Occupation: Nurse
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2026

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: 601604710
• Device Lot Number: 0000183286
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2026
• Supplement Date Received by Manufacturer: 03/16/2026
• Initial Report FDA Received Date: 03/06/2026
• Supplement Report FDA Received Date: 04/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/17/2025
• 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: R-26-025
• Patient Sequence Number: 1
• Patient Sex: Unknown