MAUDE Adverse Event Report: enableCV, LLC enableCV Thin-Flex¿ Single Stage Venous Drainage Cannula; Catheter, cannula and tubing, vascular, cardiopulmonary bypass

Model Number	TF024O90
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Reduced Blood Flow (4598)
Date of Event	06/29/2026
Type of Reportable Event	Malfunction

• Brand Name: enableCV Thin-Flex¿ Single Stage Venous Drainage Cannula
• Common Device Name: Catheter, cannula and tubing, vascular, cardiopulmonary bypass
• Manufacturer (Section D): enableCV, LLC; 6967 s. river gate dr; ste 104; midvale UT 84047
• Manufacturer (Section G): enableCV, LLC; 6967 s. river gate dr; ste 104; midvale UT 84047
• Manufacturer Contact: dannette crooms ; 6967 s. river gate dr; ste 104; midvale, UT 84047 ; +1(801)842-4930
• MDR Report Key: 50075735
• Report Number: 3031571797-2026-00020
• Device Sequence Number: 10320135
• Product Code: DWF
• UDI-Device Identifier: 00840479400716
• UDI-Public: 00840479400716
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K120072
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2026

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: TF024O90
• Device Lot Number: 463126
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/24/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2026
• Supplement Date Received by Manufacturer: 09/24/2026
• Initial Report FDA Received Date: 07/29/2026
• Supplement Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/06/2025
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown