Atrieve™ Vascular Snare Kit 382007030Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 20886333003994), received between Mar 18, 2021 and Jan 2, 2026 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJan 2, 2026Detachment of Device or Device Component

  A CUSTOMER REPORTED THE DEVICE WAS USED AT STENT-GRAFTING PROCEDURE ADDRESSING ABDOMINAL AORTIC ANEURYSM. INSERTED THE DELIVERY CATHETER THROUGH THE LEFT FEMORAL ARTERY WITH OVER-THE-WIRE TECHNIC TO CATCH THE CONTRALATERAL AFX I IMB WIRE ON THE RIGHT SIDE. AFTER REMOVING THE GUIDEWIRE WHEN THE DELIVERY CATHETER REACHED THE TERMINAL AND ADVANCED THE SNARE. ATTEMPTED TO CATCH THE AFX WIRE BY THE SNARE LOOPS, HOWEVER, THE WIRE COULD NOT BE CAUGHT SUCCESSFULLY. THEN TO CHANGE THE LOCATION OF THE CATCHING, THE SNARE WAS ADVANCED FURTHER, BUT BECAUSE COMMON ILIAC ARTERY WAS HIGHLY TORTUOUS, MAKING IT DIFFICULT FOR THE DEVICE TO ADVANCE. DURING THIS MANIPULATION, THE MARKER BAND ON THE DELIVERY CATHETER CAME OFF AND IT REMAINED AT THE DISTAL END OF THE LEFT INTERNAL ILIAC ARTERY (LIKELY THE SUPERIOR GLUTEAL ARTERY). IT WAS DETERMINED THAT RETRIEVING THE MARKER WAS NOT POSSIBLE, SO THE PROCEDURE CONTINUED AS PLANNED BY EXCHANGING THE DEVICE AND THE GUIDEWIRE WITH ANOTHER NEW ONE.

  Patient problems: Foreign Body In Patient

  MAUDE report 23950061 ↗
• InjuryJun 20, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  THE RADIOPAQUE MARK FROM THE CATHETER INCLUDED IN THE SET IS RELEASED INTO THE BLOODSTREAM, TRAVELING TO THE RIGHT VENTRICLE. THE DEVICE WAS DEPLOYED THROUGH AN INTRODUCER VENA CAVA FILTER RETRIEVAL SET, TO TRY TO REMOVE THE VENA CAVA FILTER. UNSUCCESSFUL IN A FIRST ATTEMPT WITH THIS SET, AN ATTEMPT WAS MADE TO REMOVE THE FILTER WITH THE VASCULAR SNARE LOOP SYSTEM, INSIDE THE SYSTEM OF THE PREVIOUS SET. THE OPERATING RADIOLOGIST, DUE TO THE BEHAVIOR OF THE LOOP WITH THE RADIOPAQUE MARK IN FLUOROSCOPY, NOTICES THAT THE RADIOPAQUE MARK HAS DETACHED FROM ITS SHEATH SO THEY DECIDE TO REMOVE IT. ONCE OUTSIDE, IT IS OBSERVED THAT THERE IS SOMETHING EMBRACING THE LOOPS OF THE ATRIEVE THAT, AT THAT MOMENT, STAINED WITH BLOOD AND WITH A SMALL THROMBUS, IS PERCEIVED BY THE USER AS IF IT WERE THE RADIOPAQUE BAND OF THE CATHETER THAT HAD BEEN HOOKED, WHICH IS WHY THE MATERIAL IS DISCARDED AND A DIFFERENT SNARE UNIT IS TAKEN TO PROCEED WITH A NEW ATTEMPT TO REMOVE THE FILTER. DURING THE ENTRY OF THIS NEW SYSTEM, THE RADIOPAQUE MARK, WHICH HAD ACTUALLY REMAINED INSIDE THE LONG INTRODUCER THAT HAD REMAINED ON THE PATIENT, IS PUSHED. THUS, THE RADIOPAQUE MARK IS RELEASED INTO THE BLOODSTREAM, AND

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22302073 ↗
• MalfunctionMar 7, 2024Material Puncture/Hole; Material Puncture/Hole

  THE ATRIEVE WAS USED AT AFX PROCEDURE. AN AFX SHEATH WAS INSERTED FROM RIGHT FA AND PLACED IN THE TA. AND THEN THE DELIVERY CATHETER WITH THE SNARE WAS INSERTED FROM THE LEFT FA AND PLACED IN THE TA LIKEWISE. RIGHT AFTER THAT, BLOOD SPOUTED FROM THE SURFACE OF THE DELIVERY CATHETER. THE DEVICE WAS CHECKED AND NOTICED THAT THERE WAS A PINHOLE IN THE DELIVERY CATHETER AND BLOOD WAS SPOUTING FROM THERE. THE PIN HOLE LOCATED APPROX. 37 CM FROM THE DISTAL TIP OF CATHETER. THE PHYSICIAN DETERMINED THE LOCATION OF THE PIN HOLE DID NOT AFFECT ON THE PROCEDURE, THEREFORE, HE COVERED THE PINHOLE WITH A TAPING AND CONTINUED TO USE THE DEVICE. THE TAPING THAT WAS PUT TO COVER THE PINHOLE HAD BEEN REMOVED AT THE HOSPITAL BEFORE RETURNING THE DEVICE TO SUGAN.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18856950 ↗
• MalfunctionFeb 28, 2023No Apparent Adverse Event; Activation Failure; No Apparent Adverse Event; Activation Failure

  THE FILTER DID NOT OPEN AFTER RELEASE(CC# (B)(4), AND WAS TAKEN OUT WITH OUR THREE-RING TRAP, AND ADDITIONAL EQUIPMENT NEEDED TO BE COMPENSATED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16454398 ↗
• MalfunctionApr 25, 2022Contamination

  ATRIEVE WAS USED TO REMOVE IVC FILTER AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THEN WHEN THE ATRIEVE SNARE WAS REMOVED FROM THE PATIENT, THERE WERE SOME ADHERED SUBSTANCES COILED AROUND THE SHAFT. THE ADHERED SUBSTANCES LOOKS PARTIALLY FLUFFY. (B)(6) COMMENT: THE CUSTOMER WOULD LIKE TO KNOW WHAT THESE SUBSTANCES ARE. PLEASE KINDLY ADVICE US IF THESE ARE KNOWN PHENOMENON AND/OR WHAT POSSIBLY THESE ARE. BECAUSE THE PROCEDURE WAS COMPLETED WITHOUT PROBLEM, NO CREDIT MEMO IS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 14198626 ↗
• MalfunctionMar 18, 2021Break; Material Frayed; Unraveled Material

  FOLLOW UP.

  Patient problems: Insufficient Information

  MAUDE report 11520662 ↗