ARROW IPN000333Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 30801902091773), received between Jun 10, 2022 and Jun 10, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Gas/Air Leak” (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 10, 2022Gas/Air Leak; Gas/Air Leak

  THERE WAS NO PATIENT INVOLVEMENT. IT WAS REPORTED THAT "HELIUM LOSS" WAS DISPLAYED BY THE MACHINE. AS A RESULT, THE PCS WAS REPLACED, AND THE MACHINE WAS RETURNED TO SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14659317 ↗

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-0455-2023 · Oct 17, 2022 · Open, Classified
  Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-05001 (IPN000333), 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-0429-2023 · Oct 17, 2022 · Open, Classified
  Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT2 WAVE, REF IAP-0500 (IPN000320), cardiac pump
• Z-0432-2023 · Oct 17, 2022 · Open, Classified
  Arrow AutoCAT2 Intra-Aortic Balloon Pump, AEROAUTOCAT2 WAVE REFURBISHED, REF IAP-0535X (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-0450-2023 · Oct 17, 2022 · Open, Classified
  Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500F (IPN000323), 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-0456-2023 · Oct 17, 2022 · Open, Classified
  Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500J (IPN000334), cardiac pump
• Z-0428-2023 · Oct 17, 2022 · Open, Classified
  Arrow AutoCAT2 Intra-Aortic Balloon Pump, AEROAUTOCAT2, REF IAP-0435 (IPN000312), 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-0430-2023 · Oct 17, 2022 · Open, Classified
  Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT2 WAVE REFURBISHED, REF IAP-0500X (IPN000328), 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-0452-2023 · Oct 17, 2022 · Open, Classified
  Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500J (IPN000325), 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-0445-2023 · Oct 17, 2022 · Open, Classified
  Arrow AutoCAT 2 Intra-Aortic Balloon Pump, Arrow AutoCAT 2 IABP, REF IAP-0400F (IPN000306), cardiac pump

…and 14 more.