AngioJet™ AVX™ 105039-001Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 08714729889045), received between Nov 19, 2018 and Mar 11, 2025 — classified as 1 death, 2 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 11, 2025Break; Break

  IT WAS REPORTED THAT TIP BREAK OCCURRED. AN ANGIOJET AVX WAS USED FOR THROMBECTOMY PROCEDURE. DURING THE PROCEDURE, THE CATHETER WAS BEING INSERTED ACROSS THE CLOT AND IT WAS NOTED THAT THE TIP WAS SPLIT. THE CATHETER WAS REMOVED INTACT AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. THE DEVICE WAS DISPOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21575732 ↗
• MalfunctionMar 10, 2025Difficult to Remove; Material Deformation; Difficult to Remove; Material Deformation

  IT WAS REPORTED VIA MEDWATCH (B)(4) THAT THE CATHETER BECAME STUCK IN SHEATH. A 6F X 50CM ANGIOJET AVX CATHETER WAS SELECTED FOR THROMBECTOMY PROCEDURE. HOWEVER, THE CATHETER BECAME STUCK IN THE 6F SHEATH. SUBSEQUENTLY, THE THROMBECTOMY PART OF THE CATHETER ACCORDIONED, AND NOT ALLOWING THE CATHETER TO BE EASILY REMOVED. NO COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21563586 ↗
• MalfunctionJan 31, 2024Entrapment of Device; Material Integrity Problem; Entrapment of Device; Material Integrity Problem

  IT WAS REPORTED THAT THE CATHETER STUCK, AND TIP FRAYED OCCURRED. AN ANGIOJET AVX CATHETER WAS ADVANCED FOR A THROMBECTOMY PROCEDURE. DURING THE PROCEDURE, THE PHYSICIAN NOTICED THAT THE RADIOPAQUE MARKERS WERE SUDDENLY FARTHER APART THAN NORMAL. THE DEVICE WAS PULLED OUT TO INVESTIGATE, BUT THE CATHETER WAS STUCK AND WOULD NOT COME BACK OUT OF THE SHEATH. IT WAS STUCK TO THE .035 NON-BOSTON SCIENTIFIC GLIDEWIRE AND COULD NOT GET EITHER OF THE DEVICE BACK OUT. THE THREE DEVICES HAD TO BE REMOVED ALL TOGETHER OUT OF THE PATIENT AT THE SAME TIME. ONCE THE PHYSICIAN HAD PULLED THE WIRE, THE CATHETER AND THE SHEATH OUT TOGETHER, A PORTION OF THE WIRE WAS STILL IN THE PATIENT. THEY WERE ABLE TO FREE THE CATHETER AND SHEATH FROM THE WIRE AND INSERTED A NEW SHEATH TO MAINTAIN ACCESS AND WAS ABLE TO REMOVE THE WIRE. MOREOVER, IT WAS NOTED THAT THE CATHETER TIP WAS FRAYED AND MANGLED. THE PROCEDURE WAS COMPLETED THIS DEVICE AS THEY ARE FAR ALONG IN THE CASE AND HAD GOTTEN ENOUGH CLOT OUT AND DID NOT NEED ANOTHER CATHETER OR PRODUCT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18614530 ↗
• MalfunctionJan 3, 2024Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  REPORTABLE BASED ON THE DEVICE ANALYSIS COMPLETED ON (B)(6) 2023. IT WAS REPORTED THAT HYPOTUBE BREAK OCCURRED. AN ANGIOJET AVX WAS SELECTED FOR USE IN A THROMBECTOMY PROCEDURE. HOWEVER, DURING THE PREPARATION, THE DEVICE FAILED TO PUMP AND PRIME. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A HYPOTUBE BREAK AND SHAFT BUCKLING 9 CM FROM THE PROXIMAL MARKER BAND TO THE TIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18436734 ↗
• MalfunctionDec 18, 2023Break; Break

  IT WAS REPORTED THAT TIP BREAK OCCURRED. AN ANGIOJET AVX WAS USED FOR THROMBECTOMY PROCEDURE. DURING THE PROCEDURE, THE ANGIOJET CATHETER HAD DIFFICULTY TRACKING OVER 0.035"DURING THE INITIAL PASS. WHEN WITHDRAWING, WE HAD DIFFICULTY IN REMOVING THE TIP FROM THE ENTRY SITE. AFTER THE TIP WAS SUCCESSFULLY REMOVED, IT WAS NOTED THAT THE TIP WAS CRACKED AND KINKED. ANOTHER ANGIOJET AVX CATHETER WAS SELECTED FOR USE, HOWEVER, THE TIP ALSO BROKE. 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 18349161 ↗
• MalfunctionDec 18, 2023Break; Break

  IT WAS REPORTED THAT TIP BREAK OCCURRED. AN ANGIOJET AVX WAS USED FOR THROMBECTOMY PROCEDURE. DURING THE PROCEDURE, THE ANGIOJET CATHETER HAD DIFFICULTY TRACKING OVER 0.035"DURING THE INITIAL PASS. WHEN WITHDRAWING, WE HAD DIFFICULTY IN REMOVING THE TIP FROM THE ENTRY SITE. AFTER THE TIP WAS SUCCESSFULLY REMOVED, IT WAS NOTED THAT THE TIP WAS CRACKED AND KINKED. ANOTHER ANGIOJET AVX CATHETER WAS SELECTED FOR USE, HOWEVER, THE TIP ALSO BROKE. 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 18349143 ↗
• MalfunctionDec 7, 2022Material Integrity Problem; Material Integrity Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 17-NOVEMBER-2022. IT WAS REPORTED THAT TIP DAMAGE OCCURRED. AN ANGIOJET AVX CATHETER WAS USED FOR GRAFT FISTULA PROCEDURE. UPON REMOVAL OF THE CATHETER, THEY NOTICED IT WAS MANGLED ALONG THE TIP. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. NO PATIENT COMPLICATIONS REPORTED, AND THE PATIENT'S STATUS WAS OKAY. HOWEVER, DEVICE ANALYSIS REVEALED A BROKEN HYPOTUBE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15932557 ↗
• MalfunctionOct 17, 2022Material Perforation; Material Perforation

  IT WAS REPORTED THAT SHAFT HOLE OCCURRED. AN ANGIOJET AVX WAS USED IN A THROMBECTOMY PROCEDURE. DURING PREPARATION, IT WAS NOTED THAT THE GUIDEWIRE KEPT EXITING THE OUTSIDE HOLE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15620593 ↗
• MalfunctionApr 21, 2022Material Perforation; Material Perforation

  IT WAS REPORTED THAT SHAFT HOLE OCCURRED. AN ANGIOJET AVX WAS USED IN A THROMBECTOMY PROCEDURE. DURING THE PROCEDURE, IT WAS NOTED THAT THE UNKNOWN GUIDEWIRE COULD NOT GO STRAIGHT THROUGH THE WIRE LUMEN HOLE AND CAME OUT FROM ONE OF THE SIDE HOLES OF THE CATHETER. 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 14167538 ↗
• MalfunctionDec 29, 2021Break; Leak/Splash; Suction Problem; Break; Leak/Splash; Suction Problem

  IT WAS REPORTED THAT LOSS OF ASPIRATION OCCURRED. THE TARGET LESION WAS LOCATED IN THE ARTERIOVENOUS FISTULA. AN ANGIOJET AVX CATHETER WAS ADVANCED FOR THROMBECTOMY PROCEDURE. HOWEVER, UPON REMOVING THE THROMBUS, THE DEVICE LOST SUCTION AND THE PUMP OBSERVED LEAKING. THE SHAFT WAS OBSERVED TO BE BROKEN ON A PART OF THE DEVICE EXTERNAL TO THE PATIENT. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13108963 ↗
• MalfunctionOct 1, 2021Suction Problem; Suction Problem

  IT WAS REPORTED THAT THERE WAS LOSS OF ASPIRATION. AN ANGIOJET AVX WAS USED IN A THROMBECTOMY PROCEDURE. DURING THE PROCEDURE, IT WAS NOTED THAT THERE WERE SUCTION ISSUES WITH THE SYSTEM AND THE PUMP WAS LEAKING. 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 12561856 ↗
• MalfunctionSep 27, 2021Display 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 A PROCEDURE WAS CANCELLED. THE TARGET LESION WAS LOCATED IN THE ARM FISTULA. AN ANGIOJET AVX CATHETER WAS USED FOR THROMBECTOMY PROCEDURE. DURING THE PROCEDURE, THE DEVICE COULD NOT PRIME AND THERE WAS AN ERROR MESSAGE DISPLAYED WHEN USING SEVERAL ATTEMPTS. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12538303 ↗
• MalfunctionAug 9, 2021Break; Break

  IT WAS REPORTED THAT CATHETER BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE ARM. AN ANGIOJET AVX WAS USED IN A THROMBECTOMY PROCEDURE. DURING WITHDRAWAL, IT WAS NOTED THAT THE CATHETER LOOKED LIKE IT WAS ABOUT TO SEPARATE BETWEEN THE TWO MARKERS AND THE HOLES WERE STRETCHED OUT. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12297395 ↗
• MalfunctionJun 9, 2021Suction Problem; Suction Problem

  IT WAS REPORTED THAT A LOSS OF ASPIRATION OCCURRED. TWO ANGIOJET AVX CATHETERS WERE SELECTED FOR TREATMENT. HOWEVER, AFTER CONNECTING THE DEVICE TO THE ANGIOJET THROMBECTOMY MACHINE, EACH ANGIOJET AVX CATHETER MALFUNCTIONED AND DID NOT PROPERLY ASPIRATE. NO KNOWN PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 11966650 ↗
• MalfunctionJun 9, 2021Suction Problem; Suction Problem

  IT WAS REPORTED THAT A LOSS OF ASPIRATION OCCURRED. TWO ANGIOJET AVX CATHETERS WERE SELECTED FOR TREATMENT. HOWEVER, AFTER CONNECTING THE DEVICE TO THE ANGIOJET THROMBECTOMY MACHINE, EACH ANGIOJET AVX CATHETER MALFUNCTIONED AND DID NOT PROPERLY ASPIRATE. NO KNOWN PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 11966643 ↗
• MalfunctionFeb 22, 2021Break; Therapeutic or Diagnostic Output Failure

  MIDDLE AGED MALE WITH HISTORY OF HYPERTENSION, AND RENAL FAILURE THAT RECEIVES DIALYSIS. WHILE HAVING A LEFT UPPER EXTREMITY PERCUTANEOUS THROMBECTOMY, THE BALLOON BROKE ON THE BOSTON SCIENTIFIC ANGIOJET AND THE PUMP WOULD NOT WORK. NO KNOWN HARM TO PATIENT, ANOTHER DEVICE WAS USED FOR THE PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 11357614 ↗
• MalfunctionJun 19, 2019Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE CATHETER BECAME STUCK ON THE GUIDEWIRE. AN ANGIOJET AVX CATHETER WAS SELECTED FOR A FISTULAGRAM IN THE BRACHIAL ARTERY. AFTER A LONG PASS, THE CATHETER BECAME STUCK ON THE UNSPECIFIED GUIDEWIRE. THE CATHETER AND THE GUIDEWIRE WERE PULLED OUT TOGETHER. THE ARTERY WAS RE-WIRED AND ANOTHER OF THE SAME CATHETER WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8712237 ↗
• DeathMay 23, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT DEATH OCCURRED. THE PATIENT EXPERIENCED CHEST PAIN AND LOSS OF CONSCIOUSNESS. AN ANGIOJET AVX CATHETER AND AN ANGIOJET CONSOLE WERE SELECTED FOR USE IN A DECLOT PROCEDURE IN THE LEFT ARM. DURING THE PROCEDURE, THE PATIENT EXPERIENCED SIGNIFICANT SWINGS IN AND OUT OF CONSCIOUSNESS, WAS OUT OF BREATH AND FELT TIRED; HOWEVER THE PATIENT'S HEART RATE REMAINED STABLE. WHEN BEING DISCHARGED, THE PATIENT COMPLAINED OF HAVING TO BURP, BUT COULD NOT. THE PATIENT EXPERIENCED PAIN IN THE CHEST AND WAS TAKEN TO THE EMERGENCY ROOM WHERE THE PATIENT CODED AND DIED. IT WAS FURTHER REPORTED THAT THE CASE WAS FOR A GRAFT OR FISTULA IN A HEMODIALYSIS PATIENT.

  Patient problems: Cardiopulmonary Arrest; Chest Pain; Death; Loss of consciousness

  MAUDE report 8636757 ↗
• InjuryMay 23, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED CHEST PAIN DURING THE PROCEDURE. AN ANGIOJET AVX CATHETER AND AN ANGIOJET CONSOLE WERE SELECTED FOR A DECLOT PROCEDURE IN THE LEFT ARM. DURING THE PROCEDURE, THE PATIENT EXPERIENCED CHEST PAIN. THERE WAS A SIGNIFICANT AMOUNT OF PAIN AND THE PROCEDURE HAD TO BE STOPPED. IT WAS FURTHER REPORTED THAT THE CASE WAS FOR A GRAFT OR FISTULA IN A HEMODIALYSIS PATIENT.

  Patient problems: Chest Pain

  MAUDE report 8636756 ↗
• InjuryMay 23, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED BRADYCARDIA AND VENTRICULAR TACHYCARDIA DURING THE PROCEDURE. AN ANGIOJET AVX CATHETER AND AN ANGIOJET CONSOLE WERE SELECTED FOR USE IN A DECLOT PROCEDURE IN THE LEFT ARM. DURING THE PROCEDURE, THE PATIENT'S HEART RATE WAS IN THE 80'S THEN IT DROPPED TO THE 30'S. THERE WAS A SIGNIFICANT AMOUNT OF PAIN IN THE CHEST/LUNGS AND THE PROCEDURE HAD TO BE STOPPED. ALMOST IMMEDIATELY AFTER THE USE OF THE ANGIOJET, THE PATIENT WENT INTO VENTRICULAR TACHYCARDIA. AFTER THE PROCEDURE, THE PATIENT FELT THE NEED TO VOMIT. IT WAS FURTHER REPORTED THAT THE CASE WAS FOR A GRAFT OR FISTULA IN A HEMODIALYSIS PATIENT.

  Patient problems: Bradycardia; Chest Pain; Nausea; Ventricular Tachycardia

  MAUDE report 8636753 ↗
• MalfunctionMar 14, 2019Break; Break

  IT WAS REPORTED THAT THE DEVICE SEPARATED INSIDE THE PATIENT. AN ANGIOJET AVX CATHETER WAS SELECTED FOR A THROMBECTOMY PROCEDURE. AT THE COMMENCEMENT OF THE PROCEDURE WHEN THE CATHETER WAS INSIDE THE PATIENT'S BODY, THE TIP PARTIALLY SEPARATED FROM THE CATHETER. THE WIRE WAS ALSO NOTED TO BE COMING OUT OF THE SIDE OF THE TIP. THE CATHETER AND TIP WERE THEN SUCCESSFULLY REMOVED COMPLETELY FROM THE PATIENT WITHOUT COMPLICATION. A NEW DEVICE OF THE SAME MODEL WAS USED TO COMPLETE THE PROCEDURE WITHOUT FURTHER COMPLICATIONS. THERE WAS NO HARM TO THE PATIENT AND THE PATIENT WAS FINE POST PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8421178 ↗
• MalfunctionNov 19, 2018Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE CATHETER WAS STUCK ON THE WIRE. AN ANGIOJET AVX CATHETER AND A 180AMPLATZ GUIDEWIRE WERE SELECTED FOR AN AV GRAFT DECLOT PROCEDURE. DURING THE PROCEDURE, THE CATHETER WOULD NOT PULL BACK OVER THE WIRE. ONE RING GOT CAUGHT ON THE WIRE AND WOULD NOT LET THE PHYSICIAN RETRACT THE WIRE. THE TUBING TO THE CONSOLE WAS CUT IN ORDER TO REMOVE THE WIRE AND CATHETER TOGETHER. THERE WERE NO PATIENT COMPLICATIONS REPORTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER CATHETER. RETURNED PRODUCT CONSISTED OF PORTION OF THE AVX THROMBECTOMY SYSTEM WITH APPROXIMATELY 12CM OF THE .035" GUIDEWIRE FOR THE RELATED COMPLAINT. MAJORITY OF THE EFFLUENT LINE AND SUPPLY LINE WERE CUT-OFF AND NOT RETURNED FOR ANALYSIS. THE PUMP AND PUMP ASSEMBLY WERE ALSO NOT RETURNED FOR ANALYSIS. THE EFFLUENT/SUPPLY LINE AND SHAFT WERE VISUALLY INSPECTED. BLOOD WAS PRESENT OUTSIDE AND INSIDE THE DEVICE WHEN RECEIVED. VISUAL INSPECTION OF THE DEVICE REVEALED THAT THE EFFLUENT AND SUPPLY LINES WERE CUT-OFF 7CM DISTAL OF THE BARB LUER AND THE SHAFT WAS KINKED 22CM AND 25CM DISTAL OF THE STRAIN RELIEF. THE DISTAL PORTION OF THE SHAFT WAS DETACHED AND STRETCHED AT THE PROXIMAL MARKERBAND AND PROXIMAL WINDO

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8085342 ↗