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

Model Number	IPN915325
Medical Device Problem Codes	Device Alarm System (1012); Complete Loss of Power (4015)
Health Effect - Clinical Code	Tachycardia (2095)
Date of Event	04/22/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Access to right femoral artery no complication.Iabp "[intra-aortic balloon pump]" inserted with fluoro, pump turned on, visualized full inflation.After 5-6 pumps red "high pressure" alarm; pump stopped.Patient was tachy and physician thought maybe the fast heart rate was throwing off iabp, he suggested switching from a ratio of 1:1 to 1:2.Same issue persisted.Balloon would pump 5-6 times then throw a "high pressure" red alarm.Double check under fluoro, and balloon was inflating.Physician chose to pull the sheath and balloon back in case there was a small kink.Same error.Perfusion was called into room for troubleshooting.Perfusion worked with physician and decided to decrease volume of air delivered into balloon- same error after 5-6 pumps.Perfusion decided to again decrease volume of air delivered into the iabp- balloon pump worked for 3-4 minutes then stopped again.Attempted to resolve issue for 20 minutes- decision was made based on patient condition to transition to impella.

• 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: 50438036
• Report Number: 50438036
• Device Sequence Number: 18712543
• 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: 18F24F003721
• 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: 08/25/2026
• 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