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

Summary

The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 08714729890584), received between Aug 17, 2017 and Sep 11, 2025 — classified as 42 malfunctions.

The most frequently reported specific device problem is “Display or Visual Feedback Problem” (20 reports).

2 other recalls 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 42 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 11, 2025Defective Device; Defective Device

  IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED. AN ANGIOJET CONSOLE WAS SELECTED FOR ARTERIAL THROMBECTOMY. DURING THE PROCEDURE, THE BARCODE SCANNER ON THE CONSOLE WAS NOT SCANNING. CONSEQUENTLY, THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23026374 ↗
• MalfunctionOct 1, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT ERROR 72 OCCURRED AND THE PROCEDURE WAS CANCELLED/RESCHEDULED. AN ANGIOJET ULTRA 5000A WAS SELECTED FOR USE IN A THROMBECTOMY PROCEDURE. HOWEVER, DURING THE PROCEDURE, THE DEVICE ALERTED AN ERROR 72 MESSAGE. UNABLE TO CLEAR THE PROCEDURE, THE CASE WAS ABORTED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20345869 ↗
• MalfunctionApr 29, 2024Defective Device; Defective Device

  IT WAS REPORTED THAT THE PROCEDURE COULD NOT BE COMPLETED. AN ANGIOJET CONSOLE WAS SELECTED FOR USE. HOWEVER, IT WAS NOTED THAT THE ROLLER PUMP REFUSED TO WORK. DUE TO THIS ISSUE, THE PROCEDURE COULD NOT BE COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED. IT WAS FURTHER REPORTED THAT THE DEVICE KEPT GIVING A ROLLER PUMP ERROR AND WOULD NOT LOAD THE CATHETER. THE PROCEDURE WAS COMPLETED WITH A NON-BSC DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19203615 ↗
• MalfunctionNov 2, 2023Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED.AN ANGIOJET CONSOLE WAS SELECTED FOR USED FOR THROMBECTOMY PROCEDURE. DURING PREPARATION, AN ERROR CODE 94 WAS DISPLAYED BY THE MACHINE. HOWEVER, IT WAS FURTHER REPORTED THAT THE PATIENT HAD ALREADY BEEN ADMINISTERED GENERAL ANESTHESIA. AS A RESULT OF THIS OCCURRENCE, THE PROCEDURE HAD TO BE CALLED OFF. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18058699 ↗
• MalfunctionMar 30, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT FOOT PEDAL STUCK OCCURRED. AN ANGIOJET CONSOLE WAS USED FOR A THROMBECTOMY PROCEDURE. HOWEVER, WHEN THE FOOT PEDAL IS PRESSED, THE DEVICE CONTINUES TO PULSATE FLUID INTO THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16644496 ↗
• MalfunctionMar 17, 2023Suction Problem; Suction Problem

  IT WAS REPORTED THAT LOSS OF ASPIRATION OCCURRED. AN ANGIOJET ULTRA 5000A CONSOLE WAS USED FOR A THROMBECTOMY PROCEDURE. HOWEVER, DURING THE PROCEDURE, THE FAN SOUNDED LIKE IT WAS ABOUT TO DIE AND THE ASPIRATION WAS NOT WORKING TO FULL CAPACITY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16566650 ↗
• MalfunctionAug 30, 2022Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED. AN ANGIOJET CONSOLE WAS USED FOR THROMBECTOMY PROCEDURE. UPON PREPARATION, THE DEVICE SHOWED AN ERROR 28. THE DEVICE WAS REMOVED AND RESTARTED BUT THE ERROR PERSISTED. THE PROCEDURE WAS CANCELED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15321032 ↗
• MalfunctionJul 5, 2022Display or Visual Feedback Problem; Unexpected Shutdown; Display or Visual Feedback Problem; Unexpected Shutdown

  IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED. AN ANGIOJET ULTRA 5000A WAS ADVANCED FOR TREATMENT. DURING THE PROCEDURE, THE UNIT SHUT OFF AUTOMATICALLY AND A SYSTEM ERROR CODE 64 OCCURRED. THE DEVICE WERE UNABLE TO TROUBLESHOOT THE ISSUE. THE PROCEDURE WAS CANCELLED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14915336 ↗
• MalfunctionJun 14, 2022Defective Device; Adverse Event Without Identified Device or Use Problem; Defective Device; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED. AN ANGIOJET ULTRA 5000A WAS USED IN A THROMBECTOMY PROCEDURE. DURING THE PROCEDURE, THE UNIT WAS LEAKING AND DRAWER ASSEMBLY REPLACEMENT WAS NEEDED. THE PATIENT HAD BEEN SEDATED. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14687748 ↗
• MalfunctionMar 29, 2022Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED. AN ANGIOJET CONSOLE WAS USED IN A THROMBECTOMY PROCEDURE. DURING THE PREPARATION WHEN PLACING THE ANGIOJET SOLENT CATHETER INTO THE CONSOLE, THE DEVICE SHOWED AN ERROR 71. THE PROCEDURE WAS CANCELLED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13939308 ↗
• MalfunctionMar 24, 2022Display or Visual Feedback Problem; Failure to Align; Display or Visual Feedback Problem; Failure to Align

  IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED. AN ANGIOJET CONSOLE WAS USED IN A THROMBECTOMY PROCEDURE. DURING THE PROCEDURE, IT WAS NOTED THAT THE DEVICE SHOWED SALINE ERROR ON THE SCREEN AND PHYSICIAN SUSPECTED IT COULD BE AN ALIGNMENT ISSUE WITH THE DRAWER. THE PROCEDURE WAS CANCELLED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13895227 ↗
• MalfunctionFeb 23, 2022Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED. AN ANGIOJET CONSOLE WAS USED IN A THROMBECTOMY PROCEDURE. DURING THE PROCEDURE, SALINE ERROR MESSAGE WAS DISPLAYED ON THE SCREEN. THE PROCEDURE WAS CANCELLED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13584340 ↗
• MalfunctionDec 3, 2021Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED. AN ANGIOJET ULTRA 5000A WAS SELECTED FOR THROMBECTOMY PROCEDURE. HOWEVER, THE SYSTEM ALERTED CHECK SALINE ERROR. THE PROCEDURE WAS CANCELLED DUE TO THIS EVENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12923502 ↗
• MalfunctionNov 11, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE FOOT PEDAL WAS STUCK. AN ANGIOJET ULTRA 5000A WAS SELECTED FOR A THROMBECTOMY PROCEDURE. DURING THE PROCEDURE, IT WAS NOTED THAT THE PEDAL WAS STUCK. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12800764 ↗
• MalfunctionJun 11, 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 WAS ADVANCED FOR TREATMENT. HOWEVER, BEFORE IT WAS ADVANCED FOR THROMBECTOMY PROCEDURE, AN ERROR OCCURRED STATING THAT THE WRENCH INDICATOR LIGHT WAS ON AND WOULD LIKE IT SERVICED. THE PROCEDURE WAS CANCELLED DUE TO THIS EVENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11985202 ↗
• MalfunctionApr 30, 2021Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT AN ERROR MESSAGE OCCURRED. AN ANGIOJET CONSOLE AND TWO ANGIOJET SPIROFLEX CATHETERS WERE USED IN A THROMBECTOMY PROCEDURE. DURING THE PROCEDURE, THE CATHETER WAS ADVANCED HOWEVER, A CHECK FOR CATHETER KINKS ERROR OCCURRED. THE CATHETER WAS REMOVED FROM THE PATIENT'S BODY AND REPLACED WITH A NEW SPIROFLEX BUT THE SAME ERROR OCCURRED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11755962 ↗
• MalfunctionMar 29, 2021Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE SYSTEM FAILED TO FUNCTION PROPERLY. AN ANGIOJET ULTRA 5000A AND ANGIOJET CATHETER WERE USED IN A THROMBECTOMY PROCEDURE. DURING THE PROCEDURE, IT WAS NOTED THAT THE DEVICE WOULD NOT STAY IN THROMBECTOMY MODE OFTEN AND WAS REVERTING TO PULSE SPRAY MODE. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11586612 ↗
• MalfunctionMar 15, 2021Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE FOOT PEDAL MALFUNCTIONED. THE FOOT PEDAL ON AN ANGIOJET ULTRA 5000A CONSOLE WOULD ACTIVATE WITHOUT USER INPUT WHEN A CATHETER IS INSERTED INTO THE CONSOLE. THE FOOT PEDAL WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11484756 ↗
• MalfunctionJan 13, 2021Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED. AN ANGIOJET ULTRA 5000A CONSOLE WAS SELECTED FOR A THROMBECTOMY PROCEDURE. DURING PREPARATION, IT WAS NOTED THAT THE UNIT IS A GIVING A ROLLER PUMP ERROR. 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 11165612 ↗
• MalfunctionDec 17, 2020Display 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 SELECTED FOR A THROMBECTOMY PROCEDURE. HOWEVER, IT WAS NOTED THAT THE CONSOLE WAS NOT FUNCTIONING PROPERLY AND HAD SYSTEM ERROR RELAY. THE PROCEDURE WAS CANCELLED. NO PATIENT COMPLICATIONS WERE REPORTED. IT WAS FURTHER REPORTED THAT THE ISSUE OCCURRED DURING PREPARATION AND PATIENT WAS ALREADY SEDATED. IT WAS FURTHER REPORTED THAT IT WAS ERROR 15 "RELAY TEST FAILED TO COMPLETE" THAT OCCURRED.

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

  MAUDE report 11028142 ↗
• MalfunctionDec 10, 2020Failure to Disconnect; Failure to Disconnect

  IT WAS REPORTED THAT THE FOOTSWITCH FAILED TO RELEASE AND THE PROCEDURE WAS CANCELLED. AN ANGIOJET ULTRA 5000A WAS SELECTED FOR A THROMBECTOMY PROCEDURE. DURING PREPARATION, IT WAS NOTED THAT THE UNIT WAS OPERATING LIKE THE FOOT PEDAL IS BEING DEPRESSED EVEN THOUGH IT IS NOT IN USE. 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 10983770 ↗
• MalfunctionNov 16, 2020Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED. AN ANGIOJET ULTRA 5000A CONSOLE WAS USED FOR A THROMBECTOMY PROCEDURE. DURING THE PREPARATION, IT WAS NOTED THAT THE FOOT PEDAL WAS NO LONGER WORKING. NO PHYSICAL DAMAGE NOTED ON THE FOOT PEDAL. THE PROCEDURE WAS CANCELLED. NO PATIENT COMPLICATIONS WERE REPORTED.

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

  MAUDE report 10846068 ↗
• MalfunctionOct 30, 2020Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED. AN ANGIOJET ULTRA 5000A WAS USED FOR A THROMBECTOMY PROCEDURE. DURING PROCEDURE, IT WAS NOTED THAT A ROLLER PUMP ERROR OCCURRED. THE SYSTEM WAS REBOOTED BUT STILL THE SAME ERROR OCCURRED. THE PROCEDURE WAS CANCELLED. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT IS WELL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10762609 ↗
• MalfunctionOct 27, 2020Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT AN ERROR MESSAGE OCCURRED DURING THROMBECTOMY MODE. AN ANGIOJET ULTRA 5000A CONSOLE WAS USED WITH AN UNKNOWN ANGIOJET CATHETER FOR A THROMBECTOMY PROCEDURE. DURING PROCEDURE WHILE IN THROMBECTOMY MODE, IT WAS NOTED THAT AN ERROR MESSAGE WAS DISPLAYED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10742888 ↗
• MalfunctionOct 19, 2020Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED. AN ANGIOJET ULTRA 5000A WAS USED FOR A THROMBECTOMY PROCEDURE. DURING PROCEDURE, IT WAS NOTED THAT SYSTEM ERROR 56 OR ACTUATUATOR CONTROLLER FAULT ERROR AND SYSTEM ERROR 72 OR ACTUATOR FOUND MOVING ERROR OCCURRED. THE PROCEDURE WAS CANCELLED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10697768 ↗

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-0717-2020 · Nov 8, 2019 · Terminated
  AngioJet Ultra Consoles-Thrombectomy System UPN: 105650-001D 105650-001H 105650-001R 105650-001Z 105650-002R 105650-004H 105650-004R 105650-007R 105650-009R 105650-024H
• 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