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

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 08714729890607), received between Dec 16, 2016 and Feb 8, 2023 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Defective Device” (4 reports).

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 ↗

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 8, 2023Display or Visual Feedback Problem; Defective Device; Adverse Event Without Identified Device or Use Problem; Display or Visual Feedback Problem; Defective Device; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED. AN ANGIOJET ULTRA 5000A CONSOLE WAS SELECTED FOR USE. DURING PREPARATION, THE UNIT WAS LEAKING AND THE DRAWER WAS SUSPECTED TO BE DEFECTIVE. THE PROCEDURE WAS CANCELLED DUE TO THIS EVENT. NO PATIENT COMPLICATIONS WERE REPORTED. IT WAS FURTHER REPORTED THAT ERROR 69 AND 43 OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16327693 ↗
• MalfunctionDec 19, 2022Defective Device; Defective Device

  IT WAS REPORTED THAT A PROCEDURE WAS CANCELLED. AN ANGIOJET CONSOLE WAS SELECTED FOR THROMBECTOMY PROCEDURE. HOWEVER, DURING THE USE OF THE UNIT, IT WAS NOTICED THAT THERE WAS LIQUID LEAKING AND SUSPECTED A BAD DRAWER ASSEMBLY. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16007000 ↗
• MalfunctionNov 18, 2021Display or Visual Feedback Problem; Mechanical Problem; Display or Visual Feedback Problem; Mechanical Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED. AN ANGIOJET ULTRA 5000A WAS USED IN A THROMBECTOMY PROCEDURE. DURING THE PROCEDURE, THE DEVICE WAS NOT FUNCTIONING PROPERLY AND THE DRAWER WAS STALLING. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED. IT WAS FURTHER REPORTED THAT THE PATIENT WAS SEDATED WHEN THE PROBLEM OCCURRED AND DEVICE SHOWED AN ERROR MESSAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12834557 ↗
• MalfunctionSep 13, 2021Display or Visual Feedback Problem; Defective Device; Display or Visual Feedback Problem; Defective Device

  IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED. AN ANGIOJET ULTRA 5000A CONSOLE WAS USED IN A THROMBECTOMY PROCEDURE. DURING THE PROCEDURE, THE UNIT COULD NOT RECOGNIZED ANY CATHETER AND DRAWER REPLACEMENT WAS REQUIRED. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. NO FURTHER COMPLICATIONS WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12463491 ↗
• MalfunctionMay 21, 2021Defective Device; Defective Device

  IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED. AN ANGIOJET ULTRA 5000A CONSOLE AND AN ANGIOJET CATHETER WERE USED IN A THROMBECTOMY PROCEDURE. DURING THE PROCEDURE, THE UNIT WAS GIVING A CHECK SALINE SUPPY ERROR MESSAGE. A DRAWER REPLACEMENT WAS REQUIRED. THE PROCEDURE WAS CANCELLED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11864200 ↗
• MalfunctionJan 15, 2021Display or Visual Feedback Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED. AN ANGIOJET ULTRA 5000A WAS SELECTED FOR A THROMBECTOMY PROCEDURE. HOWEVER, THE SYSTEM ALERTED ERROR CODE 60. THE PROCEDURE WAS CANCELLED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11177391 ↗
• MalfunctionMar 21, 2018Loss of Power; Loss of Power

  IT WAS REPORTED THAT LOSS OF POWER OCCURRED TO THE CONSOLE. AN ANGIOJET ULTRA SYSTEM CONSOLE WAS SELECTED FOR USE. IT WAS REPORTED THAT DURING THROMBECTOMY MODE, THE CONSOLE LOST POWER. IT WAS NOT SPECIFIED WHICH TYPE OF CATHETER WAS BEING USED AT THE TIME OF OCCURRENCE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER SAME DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7359587 ↗
• MalfunctionSep 5, 2017Device Displays Incorrect Message; Aspiration Issue; Device Displays Incorrect Message; Aspiration Issue

  IT WAS REPORTED THAT AN ERROR MESSAGE DISPLAYED DURING THE PROCEDURE. AN ANGIOJET ULTRA SYSTEM CONSOLE WAS SELECTED FOR A THROMBECTOMY PROCEDURE. DURING ASPIRATION INSIDE THE PATIENT, AN ERROR MESSAGE DISPLAYED STATING POWER SUPPLY OUT OF RANGE. THE CONSOLE WAS POWER CYCLED TO RECOVER FROM THE ERROR. THE POWER TO THE SYSTEM WAS ON A DEDICATED OUT OUTLET. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT STATUS WAS GOOD AFTER THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6841303 ↗
• MalfunctionDec 16, 2016Device Displays Incorrect Message; Aspiration Issue; Device Displays Incorrect Message; Aspiration Issue

  SAME CASE AS: 2134265-2016-11873. IT WAS REPORTED THAT AN ERROR MESSAGE DISPLAYED DURING ASPIRATION. THREE ANGIOJET® SOLENT¿ PROXI CATHETERS AND AN ANGIOJET® ULTRA SYSTEM CONSOLE WERE SELECTED FOR A THROMBECTOMY PROCEDURE IN THE LEFT ARM FISTULA. THE FIRST CATHETER WOULD NOT PRIME PAST 12 SECONDS. THE SECOND CATHETER PRIMED. ASPIRATION WAS INITIATED FOR 20 SECONDS; HOWEVER THE DEVICE STOPPED AND A CHECK SALINE SUPPLY ERROR MESSAGE WAS DISPLAYED. THE DEVICE APPEARED TO BE LEAKING FROM THE BASE OF THE PUMP. THE THIRD CATHETER WOULD NOT RECOGNIZE THE SALINE AND DISPLAYED A "CHECK SALINE" MESSAGE AND WAS UNABLE TO BE PRIMED. THE PROCEDURE WAS COMPLETED WITH A BALLOON. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT'S CONDITION WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6181094 ↗

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