Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT 2, Product Code IAP-0400
FDA Device Recall #Z-2408-2020 — Class I — May 20, 2020
Recall Summary
| Recall Number | Z-2408-2020 |
| Classification | Class I — Serious risk |
| Date Initiated | May 20, 2020 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Arrow International Inc |
| Location | Reading, PA |
| Product Type | Devices |
| Quantity | 2123 total |
Product Description
Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT 2, Product Code IAP-0400
Reason for Recall
A potential issue with a component within the above-referenced IABPs may impact the ability of the devices to operate. A Component within the IABP is susceptible to vibration failure resulting in fretting, charring, and discoloration of motor connector wires, which may result in pump alarms for System Error 3 and High Baseline presented on the screen of the IABP, and potential abrupt cessation of function or inability to start the IABP.
Distribution Pattern
Worldwide distribution.
Lot / Code Information
Serial number ranges: Arrow AutoCAT 2 Intra-Aortic Balloon Pump AUTOCAT 2 IAP-0400 140868V 140901V through 140909V 140914V through 140920V 150102V 150106V through 150107V 150110V through 150113V 150115V through 150116V 150220V 150401V 150407V 150409V 150507V through 150513V 150601V through 150605V 150608V through 150611V 150625V 150702V through 150705V 150707V 150720V 150801V through 150802V 150821V 150824V 150827V through 150830V 150901V through 150906V 150908V through 150912V 150919V through 150923V 150925V through 150939V 151009V through 151013V 151015V through 151016V 151019V 151021V through 151027V 151029V 151102V through 151103V 151105V 151108V 151111V 151113V 151201V through 151208V 151210V through 151212V 151214V through 151218V Arrow AutoCAT 2 Intra-Aortic Balloon Pump AUTOCAT 2 IAP-0400 151220V 160101V through 160103V 160105V through 160109V 160112V through 160118V 160120V 160122V 160126V 160201V through 160209V 160211V 160213V through 160214V 160216V through 160217V 160219V 160312V through 160314V 160316V through 160323V 160325V through 160327V 160331V 160401V through 160410V 160412V 160418V through 160422V 160519V 160525V 160529V through 160530V 160605V 160614V 160618V 160630V 160638V through 160639V 160645V 160703V 160718V 160720V 160726V 160728V through 160730V 170101V through 170110V 170401V through 170410V 170501V through 170520V 170601V through 170625V 170811V through 170830V 171021V through 171030V 171037V through 171046V 171106V through 171115V 180131V through 180150V Arrow AutoCAT 2 Intra-Aortic Balloon Pump AUTOCAT 2 IAP-0400 180211V through 180230V 180411V through 180420V 180441V through 180450V 180521V through 180530V 180621V through 180630V 180711V through 180720V 180741V through 180750V 180811V through 180820V 181011V through 181040V 181111V through 181130V 190121V through 190130V 190141V through 190150V 190211V through 190220V 190411V through 190420V 190431V through 190440V 190531V through 190540V 190701V through 190712V 190737V through 190748V 190813V through 190824V 190837V through 190848V 190913V through 190924V 190937V through 190948V 191001V through 191012V 191025V through 191036V 191101V through 191112V 191137V through 191148V 200113V through 200136V 200314V through 200324V
Other Recalls from Arrow International Inc
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0231-2022 | Class I | Arrow-Trerotola Over-The-Wire PTD Kit Percutane... | Sep 20, 2021 |
| Z-0232-2022 | Class I | Arrow-Trerotola Over-The-Wire PTD Kit Percutane... | Sep 20, 2021 |
| Z-0234-2022 | Class I | Arrow-Trerotola Over-The-Wire PTD Kit Percutane... | Sep 20, 2021 |
| Z-0233-2022 | Class I | Arrow-Trerotola Over-The-Wire PTD Kit Percutane... | Sep 20, 2021 |
| Z-2071-2021 | Class II | Arrow Temporary Pacing Catheter/Introducer Kit ... | May 19, 2021 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.