MAUDE Adverse Event Report: TELEFLEX INCORPORATED ARROW; System, balloon, intra-aortic and control

Model Number	IPN915325
Medical Device Problem Codes	Inflation Problem (1310); Failure to Pump (1502)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
When iabp "[intra-aortic balloon pump]" was inserted, console sounded like it inflated about 5 times- alarmed- then stopped."helium loss" (red alarm).Balloon would not inflate.Physician manually inflated iabp- no issues, attempted to run iabp again- same red "helium loss" error.Team checked helium tank just in case, everything was tight as it should be.Team switched balloon out for new balloon- new balloon worked as it should.No known harm to patient.

• Brand Name: ARROW
• Common Device Name: System, balloon, intra-aortic and control
• Manufacturer (Section D): TELEFLEX INCORPORATED; 3015 carrington mill blvd; morrisville NC 27560
• MDR Report Key: 50465554
• Report Number: 50465554
• Device Sequence Number: 9811381
• Product Code: DSP
• UDI-Device Identifier: 10801902161977
• UDI-Public: (01)10801902161977
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 06/02/2026
• Report Date (Section F): 06/02/2026

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: IPN915325
• Device Catalogue Number: IAB-S840C
• Device Lot Number: 18F25J011521
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 08/25/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/27/2026
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male
• Date Report Sent to FDA: 06/02/2026