MAUDE Adverse Event Report: Penumbra, Inc. Penumbra System RED 68 Reperfusion Catheter; NRY

Catalog Number	RED68KIT
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/15/2026
Type of Reportable Event	Malfunction

• Brand Name: Penumbra System RED 68 Reperfusion Catheter
• Common Device Name: NRY
• Manufacturer (Section D): Penumbra, Inc.; one penumbra place; alameda CA 94502
• Manufacturer (Section G): Penumbra, Inc.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica menezes ; one penumbra place; alameda, CA 94502 ; +1(510)748-3200
• MDR Report Key: 50777563
• Report Number: 3005168196-2026-00313
• Device Sequence Number: 18626645
• Product Code: NRY
• UDI-Device Identifier: 00815948024113
• UDI-Public: 00815948024113
• Combination Product (Y/N): N
• Initial Reporter Country: ID
• PMA/510(K) Number: K211411
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/15/2026

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: RED68KIT
• Device Lot Number: H00010457
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2026
• Initial Report FDA Received Date: 09/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/30/2026
• 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 Age: 56 YR
• Patient Sex: Male