MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW REDIGUARD IAB: 8FR 40CC; SYSTEM, BALLOON, INTRA-AORTIC

Catalog Number	IAB-S840C
Medical Device Problem Code	Device Alarm System (1012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/04/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Reported as "upon iabp startup, immediate high pressure and helium loss 3 alarms, large helium leak alarm".The report further states, "iabp console replaced prior to call, alarms unresolved with troubleshooting.No blood in driveline.Connected via ft offered to attempt leak test, provider opted to skip it and just exchange catheter, md advised to pull balloon and sheath per ifu.Md pulled balloon through sheath anyways and advised that is against ifu.Fos 40cc catheter place, volume adjusted to 35cc, patient is tachycardic and steep angle of insertion present.It was discussed how this can cause high pressure alarms and spoke about what to do if alarms continue.Rn verbalized understanding".No patient harm or injury.The patient status is reported as "fine".
Additional Manufacturer Narrative
(b)(4).N/a.Other remarks: n/a.Corrected data: n/a.

• Brand Name: ARROW REDIGUARD IAB: 8FR 40CC
• 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: sachin sony ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 25020600
• Report Number: 3010532612-2026-00409
• Device Sequence Number: 21448297
• Product Code: DSP
• UDI-Device Identifier: 10801902145656
• UDI-Public: (01)10801902145656(11)250911(17)270831(10)18F25J0025(21)
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K981660
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/04/2026

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 Catalogue Number: IAB-S840C
• Device Lot Number: 18F25J0025
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2026
• Supplement Date Received by Manufacturer: 04/29/2026
• Initial Report FDA Received Date: 04/28/2026
• Supplement Report FDA Received Date: 05/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/11/2025
• 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: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: N/A.; N/A.
• Patient Sex: Unknown