MAUDE Adverse Event Report: Medtronic Mexico S. De R.L. De CV BIO-MEDICUS LIFE SUPPORT TM; SINGLE LUMEN ECMO CANNULA

Model Number	LS96218-015
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2026
Type of Reportable Event	Malfunction

• Brand Name: BIO-MEDICUS LIFE SUPPORT TM
• Common Device Name: SINGLE LUMEN ECMO CANNULA
• Manufacturer (Section D): Medtronic Mexico S. De R.L. De CV; av. paseo del cucapah #10510; tijuana,bc 22210 ; MX 22210
• Manufacturer (Section G): Medtronic Mexico S. De R.L. De CV; av. paseo del cucapah #10510; tijuana,bc 22210 ; MX 22210
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; +353(091)708096
• MDR Report Key: 50559965
• Report Number: 9617601-2026-05424
• Device Sequence Number: 16079064
• Product Code: QHW
• UDI-Device Identifier: 00763000615413
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K251831
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/02/2026

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
• Operator of Device: Health Professional
• Device Model Number: LS96218-015
• Device Catalogue Number: LS96218-015
• Device Lot Number: 233165591
• 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: 08/06/2026
• Initial Report FDA Received Date: 09/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/29/2026
• 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