MAUDE Adverse Event Report: Gyrus ACMI, Inc. FLEX-CATCH 4 WIRE NITINOL BASKET; Dislodger, Stone, Flexible

Model Number	NT4F19115
Medical Device Problem Code	Difficult to Fold, Unfold or Collapse (1254)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2026
Type of Reportable Event	Malfunction

• Brand Name: FLEX-CATCH 4 WIRE NITINOL BASKET
• Common Device Name: Dislodger, Stone, Flexible
• Manufacturer (Section D): Gyrus ACMI, Inc.; 9600 louisiana avenue north; brooklyn park MN 55445
• Manufacturer (Section G): Gyrus ACMI, Inc.; 9600 louisiana avenue north; brooklyn park MN 55445
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; +1(508)207-7661
• MDR Report Key: 50305577
• Report Number: 3011050570-2026-00825
• Device Sequence Number: 10247054
• Product Code: FGO
• UDI-Device Identifier: 00821925041349
• UDI-Public: 00821925041349
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: Exempt-FGO
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2026

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: NT4F19115
• Device Lot Number: 92501957
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/21/2026
• Supplement Date Received by Manufacturer: 09/14/2026
• Initial Report FDA Received Date: 08/18/2026
• Supplement Report FDA Received Date: 10/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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