Critical RiskFDA Device

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

Agency Publication Date: December 15, 2022

Affected Products

Product: Arrow AutoCAT2 Intra-Aortic Balloon Pump, AC3 IABP NA/EMEA, REF IAP-0600 (IPN917287), cardiac pump

UDI/DI (01) 2 0801902 17208 6, (01) 2 0801902 17208 9, All Lot/Serial Numbers

Product: Arrow AutoCAT2 Intra-Aortic Balloon Pump, AC3 IABP NA/AJLA, REF IAP-0601 (IPN001109), cardiac pump

UDI/DI (01) 0 0801902 09118 5, (01) 0 0801902 09118 6, All Lot/Serial Numbers

Product: Arrow AutoCAT2 Intra-Aortic Balloon Pump, AC3 IABP NA/AJLA, REF IAP-0601(IPN916548), cardiac pump

UDI/DI (01) 2 0801902 18177 4, (01) 2 0801902 18177 7, All Lot/Serial Numbers

Product: Arrow AutoCAT2 Intra-Aortic Balloon Pump, AC3 IABP NA/AJLA, REF IAP-0601(IPN917288), cardiac pump

UDI/DI (01) 2 0801902 17209 3, (01) 2 0801902 17209 6, All Lot/Serial Numbers

Product: Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/EMEA, REF IAP-0700 (IPN001112), cardiac pump

UDI/DI (01) 0 0801902 08496 5, (01) 0 0801902 08496 6, All Lot/Serial Numbers

Product: Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/EMEA, REF IAP-0700(IPN917285), cardiac pump

UDI/DI (01) 2 0801902 17206 2, (01) 2 0801902 17206 5, All Lot/Serial Numbers

Product: Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus REFURBISHED, REF IAP-0700X (IPN914274), cardiac pump

UDI/DI (01) 2 0801902 14277 5, (01) 2 0801902 14277 8, All Lot/Serial Numbers

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

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

Product: Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/AJLA, REF IAP-0701 (IPN916549), cardiac pump

UDI/DI (01) 1 0801902 18178 4, (01) 1 0801902 18178 7, All Lot/Serial Numbers

Product: Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/AJLA, REF IAP-0701 (IPN917286), cardiac pump

UDI/DI (01) 2 0801902 17207 9, (01) 2 0801902 17207 2, All Lot/Serial Numbers

Product: Arrow AutoCAT 2 Intra-Aortic Balloon Pump, Arrow AutoCAT 2 IABP, REF IAP-0400E (IPN000305), cardiac pump

UDI/DI (01) 3 0801902 09203 9, (01) 0 0801902 09203 8, All Lot/Serial Numbers

Product: Arrow AutoCAT 2 Intra-Aortic Balloon Pump, Arrow AutoCAT 2 IABP, REF IAP-0400F (IPN000306), cardiac pump

UDI/DI (01) 0 0801902 09205 2, (01) 3 0801902 09205 3, All Lot/Serial Numbers

Product: Arrow AutoCAT 2 Intra-Aortic Balloon Pump, Arrow AutoCAT 2 IABP, REF IAP-0400J (IPN000308), cardiac pump

UDI/DI (01) 0 0801902 04341 2, (01) 3 0801902 04341 3, All Lot/Serial Numbers

Product: Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500D (IPN000321), cardiac pump

UDI/DI (01) 0 0801902 09217 5, (01) 3 0801902 09217 6, All Lot/Serial Numbers

Product: Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500E (IPN000322), cardiac pump

UDI/DI (01) 0 0801902 09216 8, (01) 3 0801902 09216 9, All Lot/Serial Numbers

Product: Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500EX (IPN000322), cardiac pump

UDI/DI (01) 0 0801902 09216 8, (01) 3 0801902 09216 9, All Lot/Serial Numbers

Product: Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500F (IPN000323), cardiac pump

UDI/DI (01) 0 0801902 09218 2, (01) 3 0801902 09218 3, All Lot/Serial Numbers

Product: Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500I (IPN000324), cardiac pump

UDI/DI (01) 0 0801902 09219 9, (01) 3 0801902 09219 0, All Lot/Serial Numbers

Product: Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500J (IPN000325), cardiac pump

UDI/DI (01) 0 0801902 04342 9, (01) 3 0801902 04342 0, All Lot/Serial Numbers

Product: Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500NL (IPN000326), cardiac pump

UDI/DI (01) 0 0801902 09172 7, (01) 3 0801902 09172 8, All Lot/Serial Numbers

Product: Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500SV (IPN000327), cardiac pump

UDI/DI (01) 0 0801902 09173 4, (01) 3 0801902 09173 5, All Lot/Serial Numbers

Product: Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-05001 (IPN000333), cardiac pump

UDI/DI (01) 0 0801902 09177 2, (01) 3 0801902 09177 3, All Lot/Serial Numbers

Product: Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500J (IPN000334), cardiac pump

UDI/DI (01) 0 0801902 09178 9, (01) 3 0801902 09178 0, All Lot/Serial Numbers

Product: Arrow AutoCAT2 Intra-Aortic Balloon Pump, AC3 IABP NA/EMEA, REF IAP-0600 (IPN001108), cardiac pump

UDI/DI (01) 0 0801902 08495 8, (01) 0 0801902 08495 9, All Lot/Serial Numbers

Product: Arrow AutoCAT2 Intra-Aortic Balloon Pump, AEROAUTOCAT2 WAVE REFURBISHED, REF IAP-0535X (IPN000329), cardiac pump

UDI/DI (01) 0 0801902 05173 8 (11) 170825 (21) 999999W, All Lot/Serial Numbers

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

UDI/DI (01) 0 0801902 05172 1, (01) 0 0801902 05172 2, All Lot/Serial Numbers

Product: Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT2 IAPB, REFURBISHED, REF IAP-0400X (IPN000311), cardiac pump

UDI/DI (01) 0 0801902 09375 2, (01) 0 0801902 09375 3, All Lot/Serial Numbers

Product: Arrow AutoCAT2 Intra-Aortic Balloon Pump, AEROAUTOCAT2, REF IAP-0435 (IPN000312), cardiac pump

UDI/DI (01) 0 0801902 05174 5, (01) 0 0801902 05174 6, All Lot/Serial Numbers

Product: Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT2 WAVE, REF IAP-0500 (IPN000320), cardiac pump

UDI/DI (01) 0 0801902 05171 4, (01) 0 0801902 05171 5, All Lot/Serial Numbers

Product: Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT2 WAVE REFURBISHED, REF IAP-0500X (IPN000328), cardiac pump

UDI/DI (01) 0 0801902 09391 2, (01) 0 0801902 09391 3, All Lot/Serial Numbers

Product: Arrow AutoCAT2 Intra-Aortic Balloon Pump, AEROAUTOCAT 2 WAVE, REF IAP-0535 (IPN000329), cardiac pump

UDI/DI (01) 0 0801902 05173 8, (01) 0 0801902 05173 9, All Lot/Serial Numbers

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 91021

Status: Active

Manufacturer: ARROW INTERNATIONAL Inc.

Manufactured In: United States

Units Affected: 19 products (1394 units; 6 units; 12 units; 2678 units; 88 units; 81 units; 1 unit; 29 units; 1 unit; 4 units; 39 units; 112 units; 1 unit; 48 units; 127 units; 4 units; 15 units; 1 unit; 1 unit)

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Sources: FDA iRES · Raw API Response

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Affected Products