ARROW IPN000328Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 30801902093913), received between Jun 28, 2023 and Jun 28, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Battery Problem” (1 report).

29 other recalls cover devices cleared under the same FDA submission (K060309); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 28, 2023Battery Problem; Battery Problem

  IT WAS REPORTED THAT DURING PREVENTATIVE MAINTENANCE, THE PUMP FAILED THE BATTERY LOAD TEST. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17215630 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K060309. One submission often covers many models, so check the product and lot details in each record.

• Z-0450-2023 · Oct 17, 2022 · Open, Classified
  Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500F (IPN000323), cardiac pump
• Z-0427-2023 · Oct 17, 2022 · Open, Classified
  Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT2 IAPB, REFURBISHED, REF IAP-0400X (IPN000311), cardiac pump
• Z-0428-2023 · Oct 17, 2022 · Open, Classified
  Arrow AutoCAT2 Intra-Aortic Balloon Pump, AEROAUTOCAT2, REF IAP-0435 (IPN000312), cardiac pump
• Z-0451-2023 · Oct 17, 2022 · Open, Classified
  Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500I (IPN000324), cardiac pump
• Z-0431-2023 · Oct 17, 2022 · Open, Classified
  Arrow AutoCAT2 Intra-Aortic Balloon Pump, AEROAUTOCAT 2 WAVE, REF IAP-0535 (IPN000329), cardiac pump
• Z-0448-2023 · Oct 17, 2022 · Open, Classified
  Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500E (IPN000322), cardiac pump
• Z-0444-2023 · Oct 17, 2022 · Open, Classified
  Arrow AutoCAT 2 Intra-Aortic Balloon Pump, Arrow AutoCAT 2 IABP, REF IAP-0400E (IPN000305), cardiac pump
• Z-0454-2023 · Oct 17, 2022 · Open, Classified
  Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500SV (IPN000327), cardiac pump
• Z-0426-2023 · Oct 17, 2022 · Open, Classified
  Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT 2 IAPB, REF IAP-0400 (IPN000302), cardiac pump
• Z-0453-2023 · Oct 17, 2022 · Open, Classified
  Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500NL (IPN000326), cardiac pump
• Z-0452-2023 · Oct 17, 2022 · Open, Classified
  Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500J (IPN000325), cardiac pump
• Z-0430-2023 · Oct 17, 2022 · Open, Classified
  Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT2 WAVE REFURBISHED, REF IAP-0500X (IPN000328), cardiac pump
• Z-0447-2023 · Oct 17, 2022 · Open, Classified
  Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500D (IPN000321), cardiac pump
• Z-0445-2023 · Oct 17, 2022 · Open, Classified
  Arrow AutoCAT 2 Intra-Aortic Balloon Pump, Arrow AutoCAT 2 IABP, REF IAP-0400F (IPN000306), cardiac pump
• Z-0446-2023 · Oct 17, 2022 · Open, Classified
  Arrow AutoCAT 2 Intra-Aortic Balloon Pump, Arrow AutoCAT 2 IABP, REF IAP-0400J (IPN000308), cardiac pump

…and 14 more.