AngioJet® Spiroflex® 106553-001Recalls & reported problems

Summary

The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 08714729889380), received between Apr 3, 2018 and Sep 18, 2024 — classified as 1 injury, 37 malfunctions.

The most frequently reported specific device problem is “Display or Visual Feedback Problem” (14 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 38 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2024Break; Break

  IT WAS REPORTED THAT THE CATHETER WAS FRACTURED. AN ANGIOJET SPIROFLEX WAS SELECTED FOR THROMBECTOMY PROCEDURE. DURING THE PROCEDURE, THE CATHETER WAS FRACTURED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20247177 ↗
• MalfunctionApr 17, 2024Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT A HOLE IN THE STERILE POUCH WAS NOTED. AN ANGIOJET SPIROFLEX WAS SELECTED FOR USE. DURING UNPACKING, IT WAS FOUND THAT THERE WAS A HOLE IN THE STERILE POUCH. THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19126674 ↗
• MalfunctionMay 10, 2023Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT AN ERROR MESSAGE OCCURRED. AN ANGIOJET SPIROFLEX CATHETER WAS SELECTED FOR CORONARY THROMBECTOMY. THE CATHETER WAS SEATED INTO THE CONSOLE AND NO ISSUES WERE NOTED WITH PRIMING. DURING THE PROCEDURE, THE DEVICE WOULD ONLY ASPIRATE FOR 5 SECONDS AT A TIME AND AN ERROR MESSAGE WOULD DISPLAY. THE CATHETER WAS REMOVED AND REINSERTED, HOWEVER, THE DEVICE WOULD STILL STOP ALL ACTIVITY. THE SYSTEM WAS INSPECTED, AND NO LEAKS OR CRACKS WERE FOUND. THE PROCEDURE WAS NOT COMPLETED, AND THE PATIENT WAS SEDATED WITH LOCAL ANESTHESIA. THE PATIENT WAS PUT ON LYTICS MAY RETURN TO CATH LAB FOR REASSESSMENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16906739 ↗
• MalfunctionMar 27, 2023Contamination; Contamination

  IT WAS REPORTED THAT DEVICE WAS CONTAMINATED. AN ANGIOJET SPIROFLEX CATHETER WAS SELECTED FOR LEFT HEART CATHETERIZATION PROCEDURE. UPON OPENING THE PRODUCT, IT WAS NOTICED THAT THE DEVICE WAS LEAKING THROUGH THE STERILE PACKAGE. NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16619399 ↗
• MalfunctionJan 30, 2023Display or Visual Feedback Problem; Leak/Splash; Display or Visual Feedback Problem; Leak/Splash

  IT WAS REPORTED THAT AN ERROR MESSAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE CORONARY ARTERY. AN ANGIOJET SPIROFLEX CATHETER WAS SELECTED FOR A THROMBECTOMY PROCEDURE. DURING THROMBECTOMY MODE, LIQUID WAS OBSERVED LEAKING INSIDE THE PUMP PORTION OF THE MACHINE AND THE CONSOLE STOPPED ALL ACTIVITY WHEN PROMPTED WITH AN ERROR MESSAGE. THE PROCEDURE WAS COMPLETED WITH A NON-BSC DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16265509 ↗
• MalfunctionDec 2, 2022Break; Break

  IT WAS REPORTED THAT CATHETER BREAK OCCURRED. AN ANGIOJET SPIROFLEX WAS USED FOR THROMBECTOMY PROCEDURE. UPON PREPARATION, THE GUIDE CATHETER WAS INSERTED AND APPEARED TO BE CRACKED. 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 15905072 ↗
• MalfunctionSep 30, 2022Display or Visual Feedback Problem; Suction Problem; Display or Visual Feedback Problem; Suction Problem

  IT WAS REPORTED THAT LOSS OF ASPIRATION OCCURRED. AN ANGIOJET SPIROFLEX WAS USED IN A THROMBECTOMY PROCEDURE IN THE CIRCUMFLEX ARTERY. DURING THROMBECTOMY MODE, THE DEVICE WAS USED ONCE FOR ASPIRATION. THE PHYSICIAN THEN REMOVED THE DEVICE FROM BODY AND RETURNED IT BACK, BUT, THIS TIME IT WOULD NOT SUCTION TO ASPIRATE. AN ERROR MESSAGE WAS DISPLAYED AND NO VISIBLE DEFECTS NOTED WITH 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 15512038 ↗
• InjuryMay 23, 2022Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT CATHETER DIFFICULTY REMOVAL AND TIP BREAK OCCURRED. AN ANGIOJET SPIROFLEX WAS USED IN A THROMBECTOMY PROCEDURE. DURING THE INTRODUCTION, IT WAS NOTED THAT THE CATHETER WAS STUCK AND THE TIP BROKE OFF WHEN IT WAS TRIED TO REMOVE. THE DEVICE WAS THEN REMOVED SURGICALLY. THE PROCEDURE WAS CANCELLED. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT WAS FULLY RECOVERED AND WAS OKAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14474743 ↗
• MalfunctionNov 23, 2021Display or Visual Feedback Problem; Leak/Splash; Device Difficult to Setup or Prepare; Display or Visual Feedback Problem; Leak/Splash; Device Difficult to Setup or Prepare

  IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED. AN ANGIOJET SPIROFLEX CATHETER WAS SELECTED FOR A PATIENT LEFT HEART CATHETERIZATION TO TREAT A LARGE THROMBUS IN THE MID LAD CORONARY ARTERY. THE TARGET LESION WAS LOCATED IN THE MID-LEFT ANTERIOR DESCENDING ARTERY. DURING PREPARATION, AFTER THE PATIENT WAS SEDATED, THE DEVICE WAS LEAKING AT THE PUMP ASSEMBLY (WHERE THE WHITE COLLAR MEETS THE BULB) AND THE CATHETER FAILED TO PRIME. THERE WAS AN ERROR MESSAGE. THERE WAS NO EXTRA DEVICE TO USE. THE PROCEDURE WAS NOT COMPLETED AND THE PATIENT HAD TO BE TRANSFERRED TO ANOTHER FACILITY FOR ANOTHER ATTEMPT OF THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12863877 ↗
• MalfunctionSep 21, 2021Entrapment of Device; Detachment of Device or Device Component; Entrapment of Device; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE CATHETER WAS STUCK AND THE TIP SEPARATED. AN ANGIOJET SPIROFLEX CATHETER WAS SELECTED FOR USE IN A THROMBECTOMY PROCEDURE TREATING AN 80-90% STENOSED LESION IN THE TIBIOPERONEAL TRUNK. DURING THE ADVANCEMENT OF THE SPIROFLEX CATHETER OVER A NON BSC GUIDEWIRE, THE CATHETER GOT STUCK ON THE WIRE. THE SPIROFLEX WAS BEING REMOVED FROM THE GUIDEWIRE, OUTSIDE OF THE PATIENT, WHEN THE TIP OF THE DEVICE PULLED OFF. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12508642 ↗
• MalfunctionJul 27, 2021Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT CATHETER STUCK ON WIRE OCCURRED. AN ANGIOJET SPIROFLEX CATHETER WAS SELECTED FOR USE. DURING ADVANCING, IT WAS NOTED THAT THE CATHETER WOULD NOT ADVANCE OVER A NON-BSC WIRE AND WAS TRAPPED. THE DEVICE NEVER ENTERED THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12232248 ↗
• MalfunctionApr 28, 2021Defective Device; Defective Device

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 07-APRIL-2021. IT WAS REPORTED THAT THE DEVICE HAD A PERFORMANCE ISSUE. AN ANGIOJET SPIROFLEX CATHETER WAS USED IN A THROMBECTOMY PROCEDURE. DURING THE PROCEDURE, THE DEVICE HAD A PERFORMANCE ISSUE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED A HYPOTUBE BREAK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11740404 ↗
• MalfunctionApr 1, 2021Display or Visual Feedback Problem; Leak/Splash; Display or Visual Feedback Problem; Leak/Splash

  IT WAS REPORTED THAT AN ERROR MESSAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE CORONARY ARTERY. AN ANGIOJET SPIROFLEX WAS USED IN A THROMBECTOMY PROCEDURE. DURING THE PROCEDURE UNDER THROMBECTOMY MODE, IT WAS NOTED THAT A CHECK SALINE SUPPLY ERROR MESSAGE OCCURRED AND SALINE WAS POOLING AT THE BASE OF THE CATHETER PUMP. ANOTHER ANGIOJET SPIROFLEX WAS USED BUT STILL THE SAME ISSUE OCCURRED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11603199 ↗
• MalfunctionApr 1, 2021Display or Visual Feedback Problem; Leak/Splash; Display or Visual Feedback Problem; Leak/Splash

  IT WAS REPORTED THAT AN ERROR MESSAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE CORONARY ARTERY. AN ANGIOJET SPIROFLEX WAS USED IN A THROMBECTOMY PROCEDURE. DURING THE PROCEDURE UNDER THROMBECTOMY MODE, IT WAS NOTED THAT A CHECK SALINE SUPPLY ERROR MESSAGE OCCURRED AND SALINE WAS POOLING AT THE BASE OF THE CATHETER PUMP. ANOTHER ANGIOJET SPIROFLEX WAS USED BUT STILL THE SAME ISSUE OCCURRED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11603196 ↗
• MalfunctionJan 11, 2021Break; Leak/Splash; Break; Leak/Splash

  IT WAS REPORTED THAT CATHETER BREAK OCCURRED. AN ANGIOJET SPIROFLEX WAS USED FOR A THROMBECTOMY PROCEDURE. HOWEVER, IT WAS NOTED THAT THE DEVICE WAS CRACKED AND STARTED LEAKING AND DRIPPING. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

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

  MAUDE report 11150539 ↗
• MalfunctionJan 11, 2021Fluid/Blood Leak

  ELDERLY MALE WITH HISTORY OF DIABETES, HYPERTENSION, CEREBROVASCULAR DISEASE AND NEW ONSET OF CHEST PAIN. PROCEDURE DIAGNOSTIC CATH, HOOKED UP TO WATER, THE FIRST DEVICE SPRAYED WATER EVERYWHERE. A SECOND PRODUCT USED, AND IT ALSO WAS LEAKING WATER. A THIRD PRODUCT WAS USED WITHOUT PROBLEM. NO KNOWN HARM TO PATIENT. PLEASE MAKE NOTE; 2 PRODUCTS REPORTED ON 1 REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11146592 ↗
• MalfunctionNov 19, 2020Device Displays Incorrect Message; Material Deformation; Device Displays Incorrect Message; Material Deformation

  IT WAS REPORTED THAT AN ERROR MESSAGE WAS DISPLAYED VIA MEDWATCH (B)(4). AN ANGIOJET SPIROFLEX CATHETER WAS USED FOR A THROMBECTOMY PROCEDURE. DURING THE PROCEDURE, IT WAS NOTED THAT "SUPPLY LINE FAILURE" ERROR MESSAGE OCCURRED. THE CATHETER WAS RE-PRIMED AND A KINKED WAS NOTICED IN THE TUBING AND THE SALINE LINE WAS UNABLE TO KEPT STRAIGHTENED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10871629 ↗
• MalfunctionJun 25, 2020Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT AN ERROR MESSAGE WAS DISPLAYED. AN ANGIOJET SPIROFLEX WAS USED FOR A THROMBECTOMY PROCEDURE. DURING THE PROCEDURE, IT WAS NOTED THAT A CHECK FOR KINKS ERROR MESSAGE WAS DISPLAYED ON THE CONSOLE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10195265 ↗
• MalfunctionJun 17, 2020Material Deformation; Adverse Event Without Identified Device or Use Problem; Material Deformation; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 10-JUNE-2020. IT WAS REPORTED THAT THE CATHETER GOT KINKED. AN ANGIOJET SPIROFLEX THROMBECTOMY CATHETER WAS USED FOR TREATMENT. DURING PREPARATION, A KINK WAS NOTED WHEN THE DEVICE WAS UNPACKED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE HYPOTUBE SEPARATED 40.5CM PROXIMAL OF THE TIP.

  Patient problems: No Patient Involvement

  MAUDE report 10164277 ↗
• MalfunctionFeb 11, 2020Break; Break

  IT WAS REPORTED THAT CATHETER BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE CORONARY ARTERY. AN ANGIOJET SPIROFLEX CATHETER WAS SELECTED FOR A THROMBECTOMY PROCEDURE. HOWEVER, IT WAS NOTED THAT THE CATHETER WOULD NOT PRIME. ANOTHER ANGIOJET SPIROFLEX CATHETER WAS ADVANCED AND COMPLETED THE PROCEDURE; HOWEVER, DURING WITHDRAWAL, THE CATHETER WAS BROKEN. THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT'S BODY. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9695608 ↗
• MalfunctionJan 17, 2020Unexpected Shutdown; Unexpected Shutdown

  IT WAS REPORTED THAT SYSTEM UNEXPECTED SHUTDOWN OCCURRED. AN ANGIOJET SPIROFLEX CATHETER WAS ADVANCED FOR A THROMBECTOMY PROCEDURE. THE CATHETER WAS SUCCESSFULLY PRIMED AND WAS INSERTED INTO THE PATIENT'S BODY. HOWEVER, DURING THROMBECTOMY MODE, THE SYSTEM SHUTDOWN OR STOPPED ALL ACTIVITY. THE DEVICE WAS REMOVED AND REPRIMED AND WAS ABLE TO WORKED CORRECTLY THE SECOND TIME. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9601857 ↗
• MalfunctionJan 2, 2020Display or Visual Feedback Problem; Suction Problem; Defective Device; Display or Visual Feedback Problem; Suction Problem; Defective Device

  IT WAS REPORTED THAT AN ERROR MESSAGE WAS DISPLAYED. AN ANGIOJET SPIROFLEX CATHETER WAS SELECTED FOR USE. THE SYSTEM SHOWED AN ERROR MESSAGE INDICATING TO REPLACE THE CATHETER. NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9539231 ↗
• MalfunctionJan 2, 2020Display or Visual Feedback Problem; Suction Problem; Display or Visual Feedback Problem; Suction Problem

  IT WAS REPORTED THAT AN ERROR MESSAGE WAS DISPLAYED. AN ANGIOJET SPIROFLEX CATHETER WAS SELECTED FOR USE. THE SYSTEM SHOWED AN ERROR MESSAGE INDICATING TO REPLACE THE CATHETER. NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9539213 ↗
• MalfunctionDec 16, 2019Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT CATHETER STUCK ON WIRE OCCURRED. THE TARGET LESION WAS LOCATED BELOW THE KNEE. AN ANGIOJET SPIROFLEX CATHETER WAS SELECTED FOR THROMBECTOMY PROCEDURE. HOWEVER, DURING INSERTION, IT WAS NOTED THAT THE MONORAIL SEGMENT PORTION OF THE CATHETER WAS STUCK IN AN UNKNOWN GUIDEWIRE. THE DEVICES WERE REMOVED TOGETHER AS ONE. A NEW GUIDEWIRE WAS INSERTED AND ANOTHER OF THE SAME ANGIOJET SPIROFLEX WAS USED AND PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 9473485 ↗
• MalfunctionDec 4, 2019Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT ENTRAPPED ON GUIDEWIRE OCCURRED. AN ANGIOJET SPIROFLEX WAS USED TO TREAT THE LESION. THE CATHETER WAS SUCCESSFULLY USED FOR TWO PASSES, ON THE THIRD PASS THE WIRE AND CATHETER BECAME STUCK. BOTH THE CATHETER AND WIRE WERE REMOVED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9412172 ↗

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