AngioJet® Ultra 5000A 105650-001DRecalls & reported problems

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier.

1 other recall cover devices cleared under the same FDA submission (P980037); 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 18, 2026.

Recalls naming this device

1. Nov 8, 2019Class IITerminated

   Missing Directions for Use (DFU) - Consoles shipped to customers without the required Operator's Manual.

   Z-0717-2020 · Root cause: Reprocessing Controls · Recall details · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P980037. One submission often covers many models, so check the product and lot details in each record.

• Z-1401-2017 · Jan 31, 2017 · Terminated
  AngioJet Ultra 5000 A Console:Foot Switch Material number (U PN) 105650 Cardiovascular: The Console is a multiple-use device that controls the Thrombectomy Set. It drives the pump