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

Catalog Number	IAB-S730C
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "after the catheter inserted, the balloon can not inflate completely, change the new catheter." no patient injury or consequence reported.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).The serial number on the returned sample is (b)(6).Returned for investigation was a 30cc 7.0fr rediguard intra-aortic balloon catheter (iabc) without the original packaging.The sample was returned in a cardboard box and was in a sealed bio-hazard bag.Upon return, the one-way valve was tethered to the short driveline tubing.The bladder was fully unwrapped.No kinks or bends were noted to the returned iabc.The hemostasis cuff (proximal side) was noted discon-nected from the iabc bifurcate; the hemostasis cuff was reconnected to the iabc bifurcate with-out any difficulty.No loose connection was noted.Dried blood was noted on the exterior surfaces of the returned sample.A small amount of dried blood was noted within the helium pathway.The bladder thickness was measured at six points with measurements ranging from 0.0062in-0.0069in and was within specification of process document.The one-way valve was tested and passed.A vacuum was pulled on the one-way valve, and it held for at least 1 minute according to quality system document.The iabc central lumen was aspirated and flushed using a 60cc lab-inventory syringe.No abnormalities or debris were noted.The iabc was leak tested in accordance with testing methods from manufacturing procedure.Multiple leaks were immediately de-tected from the bladder membrane.Under microscopic inspection, two leak sites consistent with contact from a sharp object were noted at approximately 9.3cm and 9.6cm from the iabc distal tip.No other leaks were detected.A lab inventory 0.025in guidewire was back loaded through the iabc distal tip.No resistance was noted; the guidewire was able to advance through the central lumen.No blood or debris was noted.A device history record (dhr) review was conducted for the lot number with no relevant findings.The device passed all manufacturing specifications prior to release.The reported complaint for iabc "balloon cannot inflate completely" is confirmed.During the in-vestigation, two punctures consistent with contact from a sharp object, were found on the iabc bladder, which allowed blood to enter the helium pathway.The damaged bladder could cause incomplete inflation of the balloon.Based on a review of the device history record (dhr), the product met specification upon release; however, the specifications were not met during the complaint investigation due to the bladder leaks.The probable root cause is customer handling related.No further action required at this time.This will be monitored for any developing trends.
Event or Problem Description
It was reported "after the catheter inserted, the balloon can not inflate completely, change the new catheter." no patient injury or consequence reported.The patient's current condition is reported as "fine".

• 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: sachin sony ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 24687835
• Report Number: 3010532612-2026-00253
• Device Sequence Number: 9726414
• Product Code: DSP
• UDI-Device Identifier: 10801902145649
• UDI-Public: (01)10801902145649(11)241106(17)261031(10)18F24L0002(21)
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K981660
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2026

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
• Device Catalogue Number: IAB-S730C
• Device Lot Number: 18F24L0002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2026
• Supplement Date Received by Manufacturer: 03/30/2026
• Initial Report FDA Received Date: 03/25/2026
• Supplement Report FDA Received Date: 04/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/06/2024
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown