LimFlow ARC AC-US-23Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00850041730158), received between Jul 12, 2024 and Mar 14, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Fracture” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 14, 2025Fracture; Fracture

  THE PATIENT HAD A HEAVILY CALCIFIED AND TORTUOUS ANATOMY, WITH THE INTENDED ARTERIOVENOUS FISTULA (AVF) PLANNED FROM THE ANTERIOR TIBIAL ARTERY (ATA) TO THE ANTERIOR TIBIAL VEIN (ATV). THIS WAS DR. (B)(6) FIRST CASE AT (B)(6) AND THE FACILITY'S SECOND CASE OVERALL. ASSISTING VASCULAR SURGEON DR. (B)(6) AND FELLOW (B)(6) WERE BOTH SCRUBBED IN, HAVING PARTICIPATED IN THE FIRST CASE AT (B)(6). GIVEN THE PATIENT'S SEVERE CALCIFICATION AND TORTUOUS ANATOMY, ALONG WITH THE LIMITED DATA AVAILABLE ON AVF CREATION FROM THE ATA TO THE ATV, DR. (B)(6) WAS BRIEFED ON THE CHALLENGES EXPECTED IN THIS CASE. HOWEVER, THE PRIMARY DRIVER FOR PROCEEDING WAS THE PATIENT'S REFUSAL OF AMPUTATION, ESPECIALLY CONSIDERING THEIR CONTRALATERAL ABOVE THE KNEE AMPUTATION (AKA). THE PATIENT WAS FITTED WITH A 7FR 45CM SHEATH, THOUGH IT COULD NOT BE FULLY ADVANCED DOWN THE SUPERFICIAL FEMORAL ARTERY (SFA) DUE TO CALCIFICATION. ADDITIONALLY, A LARGE PANNUS LED TO A LOWER FEMORAL STICK. TO PREPARE THE ATA, ATHERECTOMY (CSI) AND BALLOON ANGIOPLASTY (4.0 POBA) WERE PERFORMED. MULTIPLE ATTEMPTS WERE MADE TO CREATE THE AVF USING THE ARC AND V-CEIVER DEVICES. AT ONE POINT, WHEN (B)(6) (FELLOW) ATTEMPTED TO DEPLOY THE NE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21612627 ↗
• MalfunctionJan 22, 2025Fracture; Fracture

  A PATIENT WITH CLTI (CHRONIC LIMB-THREATENING ISCHEMIA), CLASSIFIED AS RUTHERFORD CATEGORY 5, UNDERWENT A TADV PROCEDURE (TRANSCATHETER ARTERIALIZATION OF DEEP VEINS) USING THE LIMFLOW DEVICES ON (B)(6) 2025. THE ARC DEVICE WAS FLUSHED WITH VIPERSLIDE AT THE PHYSICIAN'S DISCRETION AND INSERTED INTO THE BODY FOR USE. THE COMMAND GUIDWIRE WAS USED TO DELIVER THE DEVICE. THE PHYSICIAN ORIGINALLY HAD DIFFICULTY THROWING THE NEEDLE FORWARD. THE ACCOUNT MANAGER REMINDED THE PHYSICIAN THAT THE VESSEL WAS EXTREMELY CALCIFIED. AFTER MULTIPLE ATTEMPTS TO SNARE INTO THE V-CEIVER, THE PHYSICIAN NOTICED THE NEEDLE WAS NO LONGER COMMUNICATING TO THE SLIDER. AT THIS MOMENT IT WAS DECIDED TO WALK OUT THE ARC DEVICE. ONCE THE DEVICE WAS OUT OF THE BODY, IT NOTICED THAT THE WIRE WAS WRAPPED MULTIPLE TIMES AROUND THE CATHETER AND THAT THE MONORAIL TIP OF THE CATHETER BROKE OFF. THERE WERE NO REMNANTS OF THE DEVICE LEFT IN THE BODY. THE PHYSICIAN PULLED OUT ANOTHER ARC DEVICE AND CROSSED THE ANATOMY SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21213567 ↗
• MalfunctionJul 12, 2024Break; Break

  THE PATIENT PRESENTED FOR TREATMENT WITH THE LIMFLOW SYSTEM. THE ANATOMY OF THE TIBIAL ARTERIES WERE EXTREMELY CALCIFIED. PRIOR TO THE LIMFLOW PROCEDURE, THE PHYSICIAN ATTEMPTED AN OFF LABEL DEEP VEIN ARTERIALIZATION AND FAILED TO PENETRATE THE ARTERIAL CALCIFIED WALL. ANGIOPLASTY WAS PERFORMED WITH 4X80MM BALLOON ACROSS THE DISTAL POPLITEAL AND ATA. THE CALCIUM WAS SIGNIFFICANT. AFTER THE LIMFLOW ARC & V-CEIVER WERE POSITIONED FOR CROSSING, SEVERAL ATTEMPTS WERE MADE TO SUCCESSFULLY CROSS ATA TO ANTERIOR TIBIAL VEIN (ATV). A NUMBER OF DEPLOYMENTS WERE ATTEMPTED (N=15). ON SEVERAL OF THESE ATTEMPTS (N~7), THE NEEDLE OF THE ARC WAS UNABLE TO PENETRATE THE CALCIFIED ARTERIAL WALL. NUMEROUS ROTATIONS OF THE CATHETER BY THE OPERATOR, AT THE DIRECTION OF THE LIMFLOW REPRESENTATIVE, WERE DONE TO MAKE THE CROSSING, YET WERE ULTIMATELY UNSUCCESSFUL. AT THE MOMENT OF THE DEVICE FAILURE, THE PHYSICIAN WAS TRYING TO REPOSITION THE DEVICE BY PULLING PROXIMALLY TO ATTEMPT CROSSING AT A NEW VESSEL POSITION. THE LIMFLOW ARC CATHETER TIP SEPARATED FROM THE MAIN CATHETER. THE NEEDLE WAS EXPOSED AND RECOVERED WITHOUT INCIDENT. THE TIP WAS ATTEMPTED TO BE REMOVED WITH ENDOVASCULAR METHODS, HOWEVER FA

  Patient problems: Vascular Dissection

  MAUDE report 19732188 ↗