MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW REDIGUARD IAB: 7FR 30CC; SYSTEM, BALLOON, INTRA-AORTIC

Model Number	IPN917533
Medical Device Problem Code	Device Alarm System (1012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported " during an urgent angioplasty procedure, upon switching on the machine, audible and visual alarms were detected.After performing the standard checks, the balloon catheter was positioned in the aorta and connected to the machine,resulting in the absence of counter pulsation.Given the urgency of the procedure due to the patient's instability, the device was replaced with another of the same type but from a different lot.Once positioned and connected,despite the persistence of the alarm signal, it performed its function, allowing the procedure to be completed ,after which it was removed".No patient injury or consequence reported.The patient's current condition is "unknown".
Additional Manufacturer Narrative
(b)(4).The reported complaint for "persistence of the alarm signal" is not able to be confirmed.The product was not returned for investigation.Based on a review of the device history record (dhr), the product met specification upon release.The root cause of the complaint is undetermined.No further action is required at this time.The reported complaint will be monitored for any developing trends.If the product is returned at a later date, a full investigation of the sample will be completed.
Event or Problem Description
It was reported " during an urgent angioplasty procedure, upon switching on the machine, audible and visual alarms were detected.After performing the standard checks, the balloon catheter was positioned in the aorta and connected to the machine, resulting in the absence of counterpulsation.Given the urgency of the procedure due to the patient's instability, the device was replaced with another of the same type but from a different lot.Once positioned and connected, despite the persistence of the alarm signal, it performed its function, allowing the procedure to be completed, after which it was removed".No patient injury or consequence reported.The patient's current condition is "unknown".

• Brand Name: ARROW REDIGUARD IAB: 7FR 30CC
• Common Device Name: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 16 elizabeth drive; chelmsford MA 01824
• Manufacturer Contact: kevin don bosco ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 24279548
• Report Number: 3010532612-2026-00095
• Device Sequence Number: 15934527
• Product Code: DSP
• UDI-Device Identifier: 10801902145649
• UDI-Public: (01)10801902145649(11)240625(17)260531(10)18F24E0117(21)
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K981660
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2026

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 Expiration Date: 05/31/2026
• Device Model Number: IPN917533
• Device Catalogue Number: IAB-S730C
• Device Lot Number: 18F24E0117
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2026
• Supplement Date Received by Manufacturer: 02/27/2026
• Initial Report FDA Received Date: 02/06/2026
• Supplement Report FDA Received Date: 03/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/25/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: N/A.; N/A.
• Patient Sex: Unknown