ARROW IPN000334Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 30801902091780), received between Apr 22, 2020 and Apr 22, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Intermittent Communication Failure” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.

• MalfunctionApr 22, 2020Mechanical Problem; Intermittent Communication Failure; Mechanical Problem; Intermittent Communication Failure

  IT WAS REPORTED THAT WHEN THE INTRA-AORTIC BALLOON PUMP (IABP) WAS IN USE ON A PATIENT, A SYSTEM ERROR 3 ALARM OCCURRED. AS A RESULT, THE IABP WAS SWAPPED OUT. THERE WAS NO REPORT OF PATIENT COMPLICATIONS, SERIOUS INJURY OR DEATH.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9986039 ↗

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-0456-2023 · Oct 17, 2022 · Open, Classified
  Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500J (IPN000334), 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-0452-2023 · Oct 17, 2022 · Open, Classified
  Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500J (IPN000325), 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-0426-2023 · Oct 17, 2022 · Open, Classified
  Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT 2 IAPB, REF IAP-0400 (IPN000302), cardiac pump
• Z-0449-2023 · Oct 17, 2022 · Open, Classified
  Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500EX (IPN000322), 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
• Z-0431-2023 · Oct 17, 2022 · Open, Classified
  Arrow AutoCAT2 Intra-Aortic Balloon Pump, AEROAUTOCAT 2 WAVE, REF IAP-0535 (IPN000329), 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-0429-2023 · Oct 17, 2022 · Open, Classified
  Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT2 WAVE, REF IAP-0500 (IPN000320), 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-0430-2023 · Oct 17, 2022 · Open, Classified
  Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT2 WAVE REFURBISHED, REF IAP-0500X (IPN000328), 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-0455-2023 · Oct 17, 2022 · Open, Classified
  Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-05001 (IPN000333), 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

…and 14 more.