Food, drugs, devices › ARROW INTERNATIONAL Inc.

Device recall: Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT 2 IAPB, REF IAP-0400 (IPN000302), cardiac pump

FDA enforcement event 91021 · Class I · initiated 17 Oct 2022 · status Ongoing

DeviceVoluntary: Firm initiated31 product recordsMorrisville, NC

ARROW INTERNATIONAL Inc. (Morrisville, NC) initiated this device recall on 17 Oct 2022; FDA lists 31 product records under event 91021, classified Class I.

FDA defines Class I as a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. 8% of the 839 device enforcement events initiated in 2022 carry the same class.

Status: Ongoing. Initiation: voluntary: firm initiated. ARROW INTERNATIONAL Inc. has 93 enforcement events on this register, with a median of 1 product record per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

ARROW INTERNATIONAL Inc., Morrisville, NC.

Reason for recall

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

Distribution

"Worldwide"

Product records

Recall number	Product	Quantity	Class	Status	Report date
Z-0426-2023	Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT 2 IAPB, REF IAP-0400 (IPN000302), cardiac pump	1394 units	Class I	Ongoing	21 Dec 2022
Z-0427-2023	Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT2 IAPB, REFURBISHED, REF IAP-0400X (IPN000311), cardiac pump	6 units	Class I	Ongoing	21 Dec 2022
Z-0428-2023	Arrow AutoCAT2 Intra-Aortic Balloon Pump, AEROAUTOCAT2, REF IAP-0435 (IPN000312), cardiac pump	12 units	Class I	Ongoing	21 Dec 2022
Z-0429-2023	Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT2 WAVE, REF IAP-0500 (IPN000320), cardiac pump	2678 units	Class I	Ongoing	21 Dec 2022
Z-0430-2023	Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT2 WAVE REFURBISHED, REF IAP-0500X (IPN000328), cardiac pump	88 units	Class I	Ongoing	21 Dec 2022
Z-0431-2023	Arrow AutoCAT2 Intra-Aortic Balloon Pump, AEROAUTOCAT 2 WAVE, REF IAP-0535 (IPN000329), cardiac pump	81 units	Class I	Ongoing	21 Dec 2022
Z-0432-2023	Arrow AutoCAT2 Intra-Aortic Balloon Pump, AEROAUTOCAT2 WAVE REFURBISHED, REF IAP-0535X (IPN000329), cardiac pump	1 unit	Class I	Ongoing	21 Dec 2022
Z-0433-2023	Arrow AutoCAT2 Intra-Aortic Balloon Pump, AC3 IABP NA/EMEA, REF IAP-0600 (IPN001108), cardiac pump	N/A	Class I	Ongoing	21 Dec 2022
Z-0434-2023	Arrow AutoCAT2 Intra-Aortic Balloon Pump, AC3 IABP NA/EMEA, REF IAP-0600 (IPN917287), cardiac pump	N/A	Class I	Ongoing	21 Dec 2022
Z-0435-2023	Arrow AutoCAT2 Intra-Aortic Balloon Pump, AC3 IABP NA/AJLA, REF IAP-0601 (IPN001109), cardiac pump	N/A	Class I	Ongoing	21 Dec 2022
Z-0436-2023	Arrow AutoCAT2 Intra-Aortic Balloon Pump, AC3 IABP NA/AJLA, REF IAP-0601(IPN916548), cardiac pump	N/A	Class I	Ongoing	21 Dec 2022
Z-0437-2023	Arrow AutoCAT2 Intra-Aortic Balloon Pump, AC3 IABP NA/AJLA, REF IAP-0601(IPN917288), cardiac pump	N/A	Class I	Ongoing	21 Dec 2022
Z-0438-2023	Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/EMEA, REF IAP-0700 (IPN001112), cardiac pump	N/A	Class I	Ongoing	21 Dec 2022
Z-0439-2023	Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/EMEA, REF IAP-0700(IPN917285), cardiac pump	N/A	Class I	Ongoing	21 Dec 2022
Z-0440-2023	Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus REFURBISHED, REF IAP-0700X (IPN914274), cardiac pump	N/A	Class I	Ongoing	21 Dec 2022
Z-0441-2023	Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/AJLA, REF IAP-0701 (IPN001113), cardiac pump	N/A	Class I	Ongoing	21 Dec 2022
Z-0442-2023	Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/AJLA, REF IAP-0701 (IPN916549), cardiac pump	N/A	Class I	Ongoing	21 Dec 2022
Z-0443-2023	Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/AJLA, REF IAP-0701 (IPN917286), cardiac pump	N/A	Class I	Ongoing	21 Dec 2022
Z-0444-2023	Arrow AutoCAT 2 Intra-Aortic Balloon Pump, Arrow AutoCAT 2 IABP, REF IAP-0400E (IPN000305), cardiac pump	29 units	Class I	Ongoing	21 Dec 2022
Z-0445-2023	Arrow AutoCAT 2 Intra-Aortic Balloon Pump, Arrow AutoCAT 2 IABP, REF IAP-0400F (IPN000306), cardiac pump	1 unit	Class I	Ongoing	21 Dec 2022
Z-0446-2023	Arrow AutoCAT 2 Intra-Aortic Balloon Pump, Arrow AutoCAT 2 IABP, REF IAP-0400J (IPN000308), cardiac pump	4 units	Class I	Ongoing	21 Dec 2022
Z-0447-2023	Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500D (IPN000321), cardiac pump	39 units	Class I	Ongoing	21 Dec 2022
Z-0448-2023	Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500E (IPN000322), cardiac pump	112 units	Class I	Ongoing	21 Dec 2022
Z-0449-2023	Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500EX (IPN000322), cardiac pump	1 unit	Class I	Ongoing	21 Dec 2022
Z-0450-2023	Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500F (IPN000323), cardiac pump	48 units	Class I	Ongoing	21 Dec 2022
Z-0451-2023	Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500I (IPN000324), cardiac pump	N/A	Class I	Ongoing	21 Dec 2022
Z-0452-2023	Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500J (IPN000325), cardiac pump	127 units	Class I	Ongoing	21 Dec 2022
Z-0453-2023	Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500NL (IPN000326), cardiac pump	4 units	Class I	Ongoing	21 Dec 2022
Z-0454-2023	Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500SV (IPN000327), cardiac pump	15 units	Class I	Ongoing	21 Dec 2022
Z-0455-2023	Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-05001 (IPN000333), cardiac pump	1 unit	Class I	Ongoing	21 Dec 2022
Z-0456-2023	Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500J (IPN000334), cardiac pump	1 unit	Class I	Ongoing	21 Dec 2022

Context

8%of 2022 device events are Class I839 events that year

31product records in this eventfirm median: 1

93events on this register for the firm

Other enforcement events for ARROW INTERNATIONAL Inc.

Initiated	Product (first record)	Type	Class	Records
26 Jul 2024	Arrow Arterial Kits and Trays as follows: (1) Arrow Arterial Access Tray with 0.025" Spring-Wire Guide (Catheter Not Inc	Device	Class II	1
29 Apr 2024	Arrow FiberOptix Intra-Aortic Balloon Catheter Kit: a) REF IAB-05830-LWS; b) REF IAB-05840-LWS; c) REF IAB-05850-LWS	Device	Class I	3
12 Feb 2024	ARROW QuickFlash Radial Artery Catherization (wire, guide, catheter), Part Numbers: a) REF AK-04220; b) REF ASK-04220-FM	Device	Class I	1
10 Aug 2023	Arrow ErgoPack, Pressure Injectable Arrowg+ard Blue Advance Two-Lumen PICC pre-loaded with Arrow VPS Precision Stylet, R	Device	Class I	4
10 Aug 2023	Arrow ErgoPack Pressure Injectable One-Lumen PICC, REF CDC-05541-HPK1A; catheter, intravascular	Device	Class II	2
19 May 2023	ARROW Endurance Extended Dwell Peripheral Catheter System	Device	Class I	1
27 Oct 2022	Arrow MAC Two-Lumen Central Venous Access Kit fr use with 7 - 7.5 Fr Catheters, REF ASK-11242-UPM1; catheter introducer	Device	Class I	2
14 Sep 2022	ARROW Pressure Injectable Arrowg+ard Blue Advance Two-Lumen Midline Kit, 5.5 Fr, 15 cm, .018 Inch dia., REF ASK-41552-JH	Device	Class II	1
5 May 2022	Arrow Three-Lumen CVC	Device	Class II	1
20 Sep 2021	Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR Product Code: PT-12709-WC The Arrow-Treroto	Device	Class I	4

All 93 events for ARROW INTERNATIONAL Inc.

Questions and answers

Why was this device recalled?

FDA's record gives the reason for recall as: "There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices."

What does Class I mean?

FDA classifies recalls by relative degree of health hazard. Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

Where was the product distributed?

FDA's distribution pattern field reads: "Worldwide"

Is the recall still ongoing?

FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.