MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW ULTRAFLEX IAB: 7.5FR 40CC; SYSTEM, BALLOON, INTRA-AORTIC

Catalog Number	IAB-06840-U
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "'failure of the intra-aortic balloon to completely inflate over its full length'.Iabp attempted to be taken out withsheath left in initially, noted balloon was broken and took out with sheath altogether.Iab removed in ot.Attempt made to remove through sheath.Iab wired snapped in process (single point break).Iab and sheath removed together.Identified iab not inflating at top and removed".No patient injury or consequence reported.The patient's current condition is reported as "fine".Please see associated mdr#: 3010532612-2026-00265.
Additional Manufacturer Narrative
(b)(4).The reported complaint that "incorrect iab removal procedure resulting in damage to the iab" is not able to be confirmed.The product was not returned for investigation.Additionally, based on the event details, the user attempted to withdraw the iabc through the sheath.As a result, an in-service has been requested to review the instructions for use (ifu) with the customer.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 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 "'failure of the intra-aortic balloon to completely inflate over its full length'.Iabp attempted to be taken out withsheath left in initially, noted balloon was broken and took out with sheath altogether.Iab removed in ot.Attempt made to remove through sheath.Iab wired snapped in process (single point break).Iab and sheath removed together.Identified iab not inflating at top and removed".No patient injury or consequence reported.The patient's current condition is reported as "fine".Please see associated mdr#: 3010532612-2026-00265.

• Brand Name: ARROW ULTRAFLEX IAB: 7.5FR 40CC
• Common Device Name: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; chelmsford MA
• 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: 24689915
• Report Number: 3010532612-2026-00283
• Device Sequence Number: 10004710
• Product Code: DSP
• UDI-Device Identifier: 10801902145748
• UDI-Public: (01)10801902145748(11)240306(17)260228(10)18F24B0071(21)
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K000729
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other Health Care Professional
• 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 Expiration Date: 02/28/2026
• Device Catalogue Number: IAB-06840-U
• Device Lot Number: 18F24B0071
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2026
• Supplement Date Received by Manufacturer: 04/16/2026
• Initial Report FDA Received Date: 03/25/2026
• Supplement Report FDA Received Date: 04/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/06/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown