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

Catalog Number	601604710
Medical Device Problem Code	No Apparent Adverse Event (3189)
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 2/9/2026, the control syringe was reported to back off of the manifold during use.The facility reported this as a safety concern for potential air leak during transseptal procedures.The manifold was discarded and replaced with another unit from the same lot, and the same issue was reported to occur.No injuries were reported.No additional information is available at this time.A sample has been requested for evaluation.It has been determined that the reported event could cause or contribute to serious injury if it were to occur again.In an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Event or Problem Description
According to the facility on 2/9/2026, the control syringe was reported to come off the back of the manifold during use.
Additional Manufacturer Narrative
According to the facility on (b)(6) 2026, "control syringe backing off of the manifold during procedures.Customer reports that this is a serious safety concern for air leak with these coming loose or off during transeptal procedures in the left atrium".After this occurred, the customer "threw away the manifold, replaced it with another one off the shelf from the same lot.Same issue occurred".No injuries were reported.No additional information is available at this time.A sample has been requested for evaluation.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.Update to h11: manufacturer narrative.Update to h6: investigation findings (c).Update to h6: investigation conclusions (d).Update to h7: if remedial action initiated, check type.Update to h9: if action reported to fda under 21 usc 360i(g), list correction/removal reporting number.

• Brand Name: MEDLINE
• Common Device Name: MTS,LEFT HEART,KIT,VIDANT MED CTR
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP - NAMIC; 10 glens falls technical park; glens falls NY 12801 3864
• Manufacturer Contact: sabrina surmaj ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 24533136
• Report Number: 3015910259-2026-00073
• Device Sequence Number: 10337771
• 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
• Initial Reporter Occupation: Nurse
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2026

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
• 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: 03/31/2026
• Initial Report FDA Received Date: 03/06/2026
• Supplement Report FDA Received Date: 04/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/17/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown