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); Therapeutic or Diagnostic Output Failure (3023)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Iabp "[intra-aortic balloon pump]" inserted into body per protocol.Pump turned on and began pumping.After 30 seconds to 1 min balloon indicating red alarm error of helium loss.Balloon not inflating under fluoroscopy.100 cc of air injected and aspirated into balloon manually.Reconnected to helium line and machine started.Balloon pumped for 10-15 seconds and given helium loss error again.Balloon not inflating under fluoroscopy.Physician decided to put new balloon into patient.Balloons switched and hooked up to machine.Balloon and machine properly inflating and working. = manufacturer response for system, balloon, intra-aortic and control, arrow (per site reporter). = issue with rediguard iabp balloons has been identified.

• 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: 50461890
• Report Number: 50461890
• Device Sequence Number: 21392605
• 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): 06/23/2026
• Report Date (Section F): 06/23/2026

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: 18F25J0111
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 08/26/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/26/2026
• 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: 06/23/2026