AngioJet™ Solent™ Proxi 109676-001Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 08714729889595), received between Sep 26, 2018 and Nov 13, 2024 — classified as 1 injury, 19 malfunctions.

The most frequently reported specific device problem is “Suction Problem” (11 reports).

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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 13, 2024Suction Problem; Defective Device; Suction Problem; Defective Device

  IT WAS REPORTED THAT LOSS OF ASPIRATION OCCURRED. AN ANGIOJET SOLENT PROXI WAS SELECTED FOR TREATMENT.DURING THE PROCEDURE, THE DEVICE WAS USED BUT FAILED TO PROVIDE SUCTION. THE MACHINE WAS RESTARTED, AND BOTH CATHETERS WERE RE-PRIMED, BUT THE ISSUE PERSISTED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THEE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20675595 ↗
• MalfunctionSep 18, 2024Suction Problem; Suction Problem

  IT WAS REPORTED THAT THERE WAS A LOSS OF ASPIRATION. AN ANGIOJET SOLENT PROXI WAS SELECTED FOR THROMBECTOMY PROCEDURE FOR A CLOTTED FISTULA. DURING THE PROCEDURE, THE ANGIOJET SOLENT PROXI CATHETER STOPPED ASPIRATING WHILE REMOVING A CLOT, LEADING TO NO FLOW INTO THE COLLECTION BAG. AFTER REMOVING THE DEVICE AND PLACING IT IN SALINE, IT STILL SHOWED NO ASPIRATION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20250701 ↗
• MalfunctionApr 26, 2023Display or Visual Feedback Problem; Device Difficult to Setup or Prepare; Display or Visual Feedback Problem; Device Difficult to Setup or Prepare

  IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED AND RESCHEDULED, AS ALL FOUR CATHETERS FAILED TO COMPLETE THE PRIMING PROCESS. THIS ANGIOJET SOLENT PROXI CATHETER WAS SELECTED FOR A THROMBECTOMY PROCEDURE TO TREAT THE CLOTTED VESSEL. HOWEVER, DURING THE PREPARATION, THE DEVICE FAILED TO COMPLETE THE PRIMING PROCESS. DURING TROUBLESHOOTING, ANOTHER ANGIOJET SOLENT PROXI CATHETER AND TWO ANGIOJET AVX CATHETERS WERE ALSO ATTEMPTED UNSUCCESSFULLY. ALL FOUR CATHETERS FAILED TO PRIME AND HAD AN ERROR CODE. THE PROCEDURE WAS CANCELLED AND RESCHEDULED. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16817716 ↗
• MalfunctionOct 10, 2022Suction Problem; Suction Problem

  IT WAS REPORTED THAT LOSS OF ASPIRATION OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ARM. AN ANGIOJET SOLENT PROXI CATHETER WAS SELECTED FOR THROMBECTOMY PROCEDURE. HOWEVER, DURING THE PROCEDURE, IT WAS NOTICED THAT THE DEVICE HAD INSUFFICIENT SUCTION. THE PROCEDURE WAS COMPLETED WITH A NON-BSC DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15571373 ↗
• MalfunctionFeb 24, 2022Suction Problem; Suction Problem

  IT WAS REPORTED THAT LOSS OF ASPIRATION OCCURRED. AN ANGIOJET SOLENT PROXI WAS USED IN A THROMBECTOMY PROCEDURE. DURING THE PROCEDURE WHILE IN THROMBECTOMY MODE, THE CATHETER DID NOT SUCTION AFTER RE-PRIMING. THERE WERE NO ERROR MESSAGES NOR VISIBLE DEFECTS REPORTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13592791 ↗
• InjuryAug 13, 2021Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE ARM FISTULA. AN ANGIOJET SOLENT PROXI CATHETER WAS USED IN A THROMBECTOMY PROCEDURE. DURING THE PROCEDURE, IT WAS NOTED THAT THE DEVICE 3CM DISTAL FROM THE TIP AT THE PROXIMAL RADIOPAQUE BAND WAS KINKED AND BROKE OFF IN THE PATIENT. A SNARE WAS USED TO GET THE BROKEN PIECE AND WAS RETRIEVED SUCCESSFULLY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12318197 ↗
• MalfunctionJul 30, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED. AN ANGIOJET SOLENT PROXI WAS USED IN A THROMBECTOMY PROCEDURE. DURING THE PROCEDURE, IT WAS NOTED THAT THE CATHETER LEAKED. THE PATIENT WAS ALREADY SEDATED AND THE PROCEDURE WAS CANCELLED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12251974 ↗
• MalfunctionJul 8, 2021Leak/Splash; Suction Problem; Leak/Splash; Suction Problem

  IT WAS REPORTED THAT LOSS OF ASPIRATION OCCURRED. AN ANGIOJET SOLENT PROXI CATHETER WAS USED FOR THROMBECTOMY PROCEDURE. DURING THE PROCEDURE, THE DEVICE DID NOT CONTINUE TO INFUSE SALINE WHEN ASPIRATION WAS LOST DURING THROMBECTOMY MODE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12139903 ↗
• MalfunctionApr 22, 2021Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED. THE TARGET LESION WAS LOCATED IN THE ARTERIOVENOUS GRAFT. AN ANGIOJET SOLENT PROXI CATHETER WAS USED IN A THROMBECTOMY PROCEDURE. HOWEVER, DURING PREPARATION, THE DEVICE STOPPED WORKING AFTER PRIMING. THE PROCEDURE WAS CANCELLED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11709652 ↗
• MalfunctionMar 29, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED. AN ANGIOJET SOLENT PROXI CATHETER WAS USED IN A THROMBECTOMY PROCEDURE. DURING THE PROCEDURE, IT WAS NOTED THAT THE PUMP WAS LEAKING SALINE. THE PROCEDURE WAS CANCELLED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11582760 ↗
• MalfunctionFeb 16, 2021Suction Problem; Suction Problem

  IT WAS REPORTED THAT INSUFFICIENT SUCTION OCCURRED. AN ANGIOJET SOLENT PROXI CATHETER WAS USED IN A THROMBECTOMY PROCEDURE. DURING PROCEDURE UNDER THROMBECTOMY MODE, IT WAS NOTED THAT THE DEVICE WAS NOT ASPIRATING AT ITS USUAL VOLUME AND WAS LEAKING FROM THE PUMP BULB. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11334276 ↗
• MalfunctionAug 28, 2020Break; Break

  IT WAS REPORTED THAT A CATHETER BREAK OCCURRED. AN ANGIOJET SOLENT PROXI CATHETER WAS USED FOR A THROMBECTOMY PROCEDURE. HOWEVER, DURING PROCEDURE, IT WAS NOTED THAT THE DEVICE BROKE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10465072 ↗
• MalfunctionJul 17, 2020Leak/Splash; Suction Problem; Leak/Splash; Suction Problem

  IT WAS REPORTED THAT LOSS OF ASPIRATION OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEG. AN ANGIOJET SOLENT PROXI CATHETER WAS USED FOR THROMBECTOMY PROCEDURE. DURING THE PROCEDURE, IT WAS NOTED THAT THE CATHETER WAS ABLE TO ASPIRATE TWICE BUT UNABLE TO DO SO ON THE THIRD TIME. BLOOD AND FLUID WERE NOTICED COMING OUT FROM THE BULB. THE CATHETER WAS REMOVED AND PREPPED ANOTHER ANGIOJET SOLENT PROXI CATHETER. THE CATHETER ALSO ASPIRATED THROMBUS A COUPLE OF TIMES BUT THEN STARTED LEAKING AGAIN. THE PROCEDURE WAS COMPLETED WITH A NON-BSC DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10288950 ↗
• MalfunctionJul 17, 2020Leak/Splash; Suction Problem; Leak/Splash; Suction Problem

  IT WAS REPORTED THAT LOSS OF ASPIRATION OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEG. AN ANGIOJET SOLENT PROXI CATHETER WAS USED FOR THROMBECTOMY PROCEDURE. DURING THE PROCEDURE, IT WAS NOTED THAT THE CATHETER WAS ABLE TO ASPIRATE TWICE BUT UNABLE TO DO SO ON THE THIRD TIME. BLOOD AND FLUID WERE NOTICED COMING OUT FROM THE BULB. THE CATHETER WAS REMOVED AND PREPPED ANOTHER ANGIOJET SOLENT PROXI CATHETER. THE CATHETER ALSO ASPIRATED THROMBUS A COUPLE OF TIMES BUT THEN STARTED LEAKING AGAIN. THE PROCEDURE WAS COMPLETED WITH A NON-BSC DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10288939 ↗
• MalfunctionApr 29, 2020Break; Break

  IT WAS REPORTED THAT CATHETER BREAK OCCURRED. AN ANGIOJET SOLENT PROXI WAS USED FOR A THROMBECTOMY PROCEDURE. HOWEVER, IT WAS NOTED THAT THE CATHETER HAD CRACKED IN MULTIPLE LOCATIONS. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT INJURIES OR COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10009642 ↗
• MalfunctionJul 3, 2019Suction Problem; Suction Problem

  IT WAS REPORTED THAT ASPIRATION OCCURRED WITHOUT ACTIVATION. AN ANGIOJET SOLENT PROXI AND ANGIOJET ULTRA 5000A WERE SELECTED FOR AN ARTERIOVENOUS FISTULA DECLOT PROCEDURE IN THE PATIENT'S LEFT ARM. THE DEVICES WERE PREPPED IN NORMAL FASHION WITH NO ISSUES OF ANY KIND. DURING THE PROCEDURE, WHILE THE DEVICE WAS ENTERING INTO THE PATIENT BUT BEFORE THE DEVICE WAS ACTIVATED, BLOOD WAS NOTED TO BE COMING OUT OF THE OUTFLOW LINE AND INTO THE WASTE BAG. THE ANGIOJET WAS NOT ACTIVATED WHEN THIS OCCURRED, AND THE FOOT PEDAL WAS NOT PRESSED. THE PHYSICIAN PROCEEDED TO USE THE DEVICE, AND IT SEEMED TO FUNCTION NORMALLY, HOWEVER IT DID NOT REMOVE THE LOCALIZED CLOT FROM THE VESSEL AS THEY INTENDED IT TO. THEREFORE THE PHYSICIAN COMPLETED THE PROCEDURE USING A DIFFERENT DEVICE AS IT WAS THOUGHT THAT A DIFFERENT DEVICE WOULD WORK BETTER FOR THIS CASE. NO FURTHER CATHETER ISSUES WERE NOTED DURING THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED. THE PATIENT CONDITION AFTER THE PROCEDURE WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8759736 ↗
• MalfunctionNov 20, 2018Leak/Splash; Leak/Splash

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 17-NOV-2018. IT WAS REPORTED THAT THE CATHETER LEAKED DURING PREPARATION OF THE DEVICE. AN ANGIOJET SOLENT PROXI CATHETER WAS SELECTED FOR A THROMBECTOMY PROCEDURE. DURING PREPARATION, THE DEVICE WAS BEING PRIMED AND THE CATHETER LEAKED. IT WAS UNKNOWN THE LOCATION OF THE LEAK. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. THE RETURNED PRODUCT CONSISTED OF A SOLENT PROXI THROMBECTOMY SYSTEM. THE PUMP, SPIKE LINE, EFFLUENT/SUPPLY LINE, SHAFT AND TIP WERE MICROSCOPICALLY AND VISUALLY INSPECTED. THERE WERE NUMEROUS KINKS THROUGHOUT THE DEVICE. FUNCTIONAL TESTING WAS PERFORMED BY PLACING THE DEVICE IN THE ANGIOJET ULTRA CONSOLE. FUNCTIONAL TESTING CONSISTED OF RUNNING THE COMPLAINT DEVICE THROUGH THE FULL PRIMING CYCLE AND IN THROMBECTOMY MODE. THE DEVICE RAN WITHIN NORMAL RANGE (10.05 KPSI) WITHOUT ANY ERRORS OR ALARMS; HOWEVER, FLUID DID LEAK FROM THE SHAFT. THE SHAFT WAS MICROSCOPICALLY INSPECTED AND A HOLE IN THE SHAFT WAS REVEALED 44.2CM DISTAL OF THE STRAIN RELIEF. INSPECTION OF THE REMAINDER OF THE DEVICE PRESENTED NO OTHER DAMAGE OR IRREGULARITIES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8091999 ↗
• MalfunctionNov 16, 2018Suction Problem; Suction Problem

  IT WAS REPORTED A LOSS OF ASPIRATION OCCURRED DURING USE. AN ANGIOJET SOLENT PROXI CATHETER WAS SELECTED FOR A THROMBECTOMY PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY. DURING THROMBECTOMY MODE, THE CATHETER DID NOT SUCK THE THROMBUS. NO ERROR MESSAGE DISPLAYED. THERE WERE NO VISUAL DEFECTS NOTED ON THE DEVICE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT'S STATUS IS FINE. DEVICE EVALUATED BY MFR: THE PUMP ASSEMBLY, EFFLUENT/SUPPLY LINE, SHAFT, TIP, PISTON, AND SPIKE LINE WERE VISUALLY INSPECTED. BLOOD WAS PRESENT OUTSIDE AND INSIDE THE DEVICE. THE WASTE BAG WAS CUT-OFF, WHEN RECEIVED. THE WASTE BAG WAS NOT RETURNED FOR ANALYSIS. FUNCTIONAL TESTING WAS PERFORMED BY PLACING THE DEVICE IN THE ANGIOJET ULTRA CONSOLE. FUNCTIONAL TESTING CONSISTED OF RUNNING THE COMPLAINT DEVICE THROUGH THE FULL PRIMING CYCLE AND 180 SECONDS IN THROMBECTOMY MODE. THE DEVICE RAN WITHIN NORMAL RANGE, WITHOUT ANY LEAKS, ISSUES OR ALARMS. THE DEVICE SUCKED NORMALLY AND THERE WAS NO ISSUES WITH THE ASPIRATION. INSPECTION OF THE DEVICE PRESENTED NO DAMAGE OR IRREGULARITIES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8080770 ↗
• MalfunctionOct 10, 2018Leak/Splash; Suction Problem; Leak/Splash; Suction Problem

  IT WAS REPORTED THAT THERE WAS A LACK OF ASPIRATION. AN ANGIOJET SOLENT PROXI WAS SELECTED FOR A THROMBECTOMY PROCEDURE IN THE FEMORAL ARTERY. THE DEVICE WAS PREPPED AND THEN AS SOON AS THEY STARTED DOING THROMBECTOMY DURING THE PROCEDURE, FLUID WAS NOT RETURNING. IT WAS NOTED THAT THE PUMP WAS LEAKING. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7952445 ↗
• MalfunctionSep 26, 2018Material Perforation; Material Perforation

  IT WAS REPORTED THAT THERE WAS A HOLE IN THE CATHETER. AN ANGIOJET SOLENT PROXI CATHETER WAS SELECTED FOR USE. DURING PROCEDURE WHILE INSIDE THE PATIENT, A HOLE IN THE CATHETER WAS OBSERVED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7911064 ↗