AngioJet Ultra 5000ARecalls & reported problems across all models
Boston Scientific Corporation · 4 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 51
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 1
We found 4 models of AngioJet Ultra 5000A by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 51 adverse event reports in the FDA's MAUDE database, received between Dec 16, 2016 and Sep 11, 2025 — classified as 51 malfunctions.
The most frequently reported specific device problem is “Display or Visual Feedback Problem” (24 reports).
1 FDA recall record name at least one of these models by its device identifier.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
AngioJet Ultra 5000A recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Nov 8, 2019Terminated
Missing Directions for Use (DFU) - Consoles shipped to customers without the required Operator's Manual.
Z-0717-2020 · Root cause: Reprocessing Controls · names 3 of these models · Recall details · FDA record ↗
Most reported AngioJet Ultra 5000A problems
Device problems
- Display or Visual Feedback Problem24
- Defective Device10
- Mechanical Problem6
- Suction Problem6
- Failure to Disconnect3
- Physical Resistance/Sticking3
- Adverse Event Without Identified Device or Use Problem2
- Aspiration Issue2
Patient problems
- No Clinical Signs, Symptoms or Conditions28
- No Consequences Or Impact To Patient22
- No Known Impact Or Consequence To Patient3
- No Patient Involvement3
AngioJet Ultra 5000A models
4 models, most reported first. Each model has its own page with its reports, recalls and device details.
- AngioJet® Ultra 5000A 105650-001RCATHETER, CORONARY, ATHERECTOMY1 recall9 reports
- AngioJet® Ultra 5000A 105650-001HCATHETER, CORONARY, ATHERECTOMY1 recall0 reports
- AngioJet® Ultra 5000A 105650-001DCATHETER, CORONARY, ATHERECTOMY1 recall0 reports
- AngioJet® Ultra 5000A 105650-001CATHETER, CORONARY, ATHERECTOMY42 reports
Recent AngioJet Ultra 5000A adverse event reports
The 15 most recent reports across all models, 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 ↗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 ↗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 ↗
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Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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