ARROW IPN000312Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 30801902051746), received between Sep 21, 2018 and Sep 21, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Pumping Stopped” (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.

• MalfunctionSep 21, 2018Pumping Stopped; Pumping Stopped

  IT WAS REPORTED THAT WHILE ON A PATIENT THE UNIT STOPPED PUMPING AND HAD TO CYCLE POWER 5 TIMES TO GET PUMP TO RESUME PUMPING. THERE WERE NO PATIENT COMPLICATIONS REPORTED. THE FIELDS SERVICE ENGINEER (FSE) COULD NOT REPRODUCE THE REPORTED PROBLEM WITH OPERATION. THERE WERE NO REPORTS OF PATIENT CONSEQUENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7898851 ↗

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-0426-2023 · Oct 17, 2022 · Open, Classified
  Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT 2 IAPB, REF IAP-0400 (IPN000302), 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-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-0449-2023 · Oct 17, 2022 · Open, Classified
  Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500EX (IPN000322), 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-0456-2023 · Oct 17, 2022 · Open, Classified
  Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500J (IPN000334), 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-0432-2023 · Oct 17, 2022 · Open, Classified
  Arrow AutoCAT2 Intra-Aortic Balloon Pump, AEROAUTOCAT2 WAVE REFURBISHED, REF IAP-0535X (IPN000329), 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-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-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-0453-2023 · Oct 17, 2022 · Open, Classified
  Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500NL (IPN000326), 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-0447-2023 · Oct 17, 2022 · Open, Classified
  Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500D (IPN000321), cardiac pump

…and 14 more.