AngioJet® Spiroflex® VG 106608-001Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 08714729889441), received between Jan 31, 2020 and Jan 18, 2022 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Display or Visual Feedback Problem” (4 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 18, 2022Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED VIA MEDWATCH MW5105369 ATTACHED. AN ANGIOJET SPIROFLEX WAS USED FOR AN EMERGENT LEFT HEART CATHETERIZATION. UPON LOADING THE CATHETER ONTO THE WIRE, PRIOR TO INSERTION INTO THE BODY, THE CATHETER BROKE AND FLUID WAS LEAKING AROUND THE CATHETER SHAFT. THE CATHETER WAS IMMEDIATELY REMOVED AND PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13282620 ↗
• MalfunctionNov 24, 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-LEFT ANTERIOR DESCENDING ARTERY. DURING PREPARATION, AFTER THE PATIENT WAS ALREADY SEDATED, THE DEVICE WAS LEAKING AT THE PUMP ASSEMBLY (WHERE THE CONNECTION FOR THE BACK/PRIMING TUBE MEETS THE BULB), FAILED TO PRIME, AND THERE WAS AN ERROR MESSAGE. THERE WAS NO EXTRA DEVICE TO USE SO THE PROCEDURE WAS CANCELLED. THEY NEEDED TO BORROW A CATHETER FROM ANOTHER FACILITY, SO THE PATIENT WAS RESCHEDULED TO BE BROUGHT BACK TO THE CATH LAB THE FOLLOWING DAY. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12867593 ↗
• MalfunctionNov 23, 2021Break; Break

  IT WAS REPORTED THAT SHAFT BECAME SEPARATED. AN ANGIOJET SPIROFLEX CATHETER WAS SELECTED FOR A PATIENT PROCEDURE TO TREAT AN ACUTE MYOCARDIAL INFARCTION. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND NON-CALCIFIED SAPHENOUOS VEIN GRAFT. AFTER THE DEVICE WAS FULLY PRIMED, THE DISTAL PORTION OF THE CATHETER STARTED TO SEPARATE FROM ITSELF WHEN PLACED ON THE WIRE. THE SEPARATION CONTINUED BACK TO MID PART OF THE CATHETER. THE CATHETER WAS THEN REMOVED FROM THE WIRE AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THE DEVICE NEVER ENTERED THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12863381 ↗
• MalfunctionMay 18, 2021Difficult to Advance; Material Integrity Problem; Difficult to Advance; Material Integrity Problem

  IT WAS REPORTED THAT SHAFT DAMAGE OCCURRED. AN ANGIOJET SPIROFLEX VG WAS SELECTED FOR USE IN A THROMBECTOMY PROCEDURE. THE TARGET LESION WAS LOCATED IN THE SAPHENOUS VEIN GRAFT. DURING INSERTION, IT WAS NOTED THAT RESISTANCE WAS FELT WHILE THE CATHETER WAS ADVANCING ONTO THE GUIDEWIRE. THE METAL SHAFT WAS FOUND TO BE UNRAVELING, BUT STILL INTACT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, WITH ANOTHER ANGIOJET SPIROFLEX VG. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11839475 ↗
• MalfunctionSep 8, 2020Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT AN ERROR MESSAGE WAS DISPLAYED. AN ANGIOJET SPIROFLEX VG CATHETER WAS USED FOR A THROMBECTOMY PROCEDURE. HOWEVER, THE DEVICE WOULD NOT SUCK SALINE IN AND ALERTED TO REPLACE WITH A NEW CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10504827 ↗
• MalfunctionApr 16, 2020Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT AN ERROR MESSAGE OCCURRED. AN ANGIOJET SPIROFLEX CATHETER WAS SELECTED FOR USE. DURING THROMBECTOMY, AN ERROR MESSAGE APPEARED WHICH DISPLAYED "CHECK FLUSH BAG/NO FLOW". THIS OCCURRED AFTER 4 SECONDS OF ACTIVE USE. A NEW ANGIOJET SPIROFLEX CATHETER WAS SELECTED FOR USE. DURING THROMBECTOMY WHILE INSIDE THE PATIENT, THE SAME ERROR CODED APPEARED. THEY WERE NO VISIBLE DEFECTS NOTED ON EITHER DEVICE. THE PROCEDURE WAS COMPLETED, AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9968728 ↗
• MalfunctionApr 16, 2020Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT AN ERROR MESSAGE OCCURRED. AN ANGIOJET SPIROFLEX CATHETER WAS SELECTED FOR USE. DURING THROMBECTOMY, AN ERROR MESSAGE APPEARED WHICH DISPLAYED "CHECK FLUSH BAG/NO FLOW". THIS OCCURRED AFTER 4 SECONDS OF ACTIVE USE. A NEW ANGIOJET SPIROFLEX CATHETER WAS SELECTED FOR USE. DURING THROMBECTOMY WHILE INSIDE THE PATIENT, THE SAME ERROR CODED APPEARED. THEY WERE NO VISIBLE DEFECTS NOTED ON EITHER DEVICE. THE PROCEDURE WAS COMPLETED, AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9968686 ↗
• MalfunctionJan 31, 2020Suction Problem; Suction Problem

  IT WAS REPORTED THAT A LOSS OF ASPIRATION OCCURRED. AN ANGIOJET SOLENT OMNI CATHETER AND AN ANGIOJET SPIROFLEX VG CATHETER WERE SELECTED FOR A THROMBECTOMY PROCEDURE. HOWEVER, DURING THE PROCEDURE, IT WAS NOTED THAT THE DEVICES WOULD NOT ASPIRATE. THE PROCEDURE WAS COMPLETED BY DOING A BALLOON ANGIOPLASTY. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9652788 ↗

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