Home / Recalls / ARROW INTERNATIONAL Inc. / Z-0441-2023

Z-0441-2023 Class I Ongoing

Recalled by ARROW INTERNATIONAL Inc. — Morrisville, NC

Recall Details

Product Type
Devices
Report Date
December 21, 2022
Initiation Date
October 17, 2022
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
N/A

Product Description

Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/AJLA, REF IAP-0701 (IPN001113), cardiac pump

Reason for Recall

There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.

Distribution Pattern

Worldwide

Code Information

UDI/DI (01) 0 0801902 09125 3, (01) 0 0801902 09125 3, All Lot/Serial Numbers

Other recalls by ARROW INTERNATIONAL Inc.

  • Z-3299-2024 Class II — Arrow Arterial Kits and Trays as follows: (1) Arrow Arterial Access Tray with (July 26, 2024)
  • Z-1878-2024 Class I — Arrow FiberOptix Intra-Aortic Balloon Catheter Kit: a) REF IAB-05830-LWS; b) (April 29, 2024)
  • Z-1880-2024 Class I — Arrow Ultra 8 IAB Intra-Aortic Balloon Catheter Kit, a) REF IAB-05830-U; b) RE (April 29, 2024)
  • Z-1879-2024 Class I — Arrow UltraFlex Intra-Aortic Balloon Catheter Kit, a) REF IAB-06830-U; b) REF (April 29, 2024)
  • Z-1267-2024 Class I — ARROW QuickFlash Radial Artery Catherization (wire, guide, catheter), Part Numbe (February 12, 2024)
  • Z-0004-2024 Class I — Arrow ErgoPack Pressure Injectable Arrowg+ard Blue Advance Three-Lumen PICC pre- (August 10, 2023)
  • Z-2590-2023 Class II — Arrow ErgoPack Pressure Injectable One-Lumen PICC, REF CDC-05541-HPK1A; catheter (August 10, 2023)
  • Z-2591-2023 Class II — Arrow ErgoPack, Pressure Injectable Two-Lumen PICC pre-loaded with Arrow VPS Sty (August 10, 2023)
  • Z-0003-2024 Class I — Arrow Pressure Injectable Arrowg+ard Blue Plus¿ Four-Lumen CVC, REF CDC-45854-P1 (August 10, 2023)
  • Z-0001-2024 Class I — Arrow ErgoPack, Pressure Injectable Arrowg+ard Blue Advance Two-Lumen PICC pre-l (August 10, 2023)