MAUDE Adverse Event Report: Galt Medical Corp. Transcarotid/Peripheral Access Kit; Introducer Kit

Lot Number	G25252909
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Embolism/Embolus (4438)
Type of Reportable Event	Malfunction

• Brand Name: Transcarotid/Peripheral Access Kit
• Common Device Name: Introducer Kit
• Manufacturer (Section D): Galt Medical Corp.; 2220 merritt dr; garland 75041
• Manufacturer (Section G): Galt Medical Corp.; 2220 merritt dr; garland TX 75041
• Manufacturer Contact: david derrick ; 2220 merritt dr; garland, TX 75041 ; +1(214)778-1306
• MDR Report Key: 50160616
• Report Number: 1649395-2026-00008
• Device Sequence Number: 18417750
• Product Code: OFL
• UDI-Device Identifier: 00841268107250
• UDI-Public: 00841268107250
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 08/06/2026

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 Lot Number: G25252909
• 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: 08/06/2026
• Initial Report FDA Received Date: 08/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/10/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 1649395-06-24-2026-001-R
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown