MAUDE Adverse Event Report: ABBOTT VASCULAR INC. Armada; Peripheral Dilatation Catheter

Model Number	B2070-040
Medical Device Problem Codes	Leak/Splash (1354); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2026
Type of Reportable Event	Malfunction

• Brand Name: Armada
• Common Device Name: Peripheral Dilatation Catheter
• Manufacturer (Section D): ABBOTT VASCULAR INC.; 3200 lakeside drive; santa clara CA 95054 -280
• Manufacturer (Section G): Abbott Vascular Costa Rica, Reg # 3009564766; 52 calle 3 b31 coyol free zone; el coyol alajuela UNK ; CS UNK
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591--462 ; +1(951)914-5259
• MDR Report Key: 50936001
• Report Number: 2024168-2026-03754
• Device Sequence Number: 18831244
• Product Code: LIT
• UDI-Device Identifier: 08717648155352
• UDI-Public: (01)08717648155352(17)291031(10)60529G1
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K111899
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/29/2026

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 Model Number: B2070-040
• Device Catalogue Number: B2070-040
• Device Lot Number: 60529G1
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/16/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2026
• Initial Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/29/2026
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown