VIATRAC 1008201-20Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08717648057304), received between Apr 26, 2021 and Oct 24, 2022 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryOct 24, 2022Off-Label Use; Material Separation; Off-Label Use; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A CAROTID ARTERY. THE VIATRAC BALLOON WAS ADVANCED WITHOUT ISSUE TO THE TARGET LESION. DURING THE FIRST INFLATION AT AN UNSPECIFIED ATMOSPHERE, THE BALLOON COMPLETELY SEPARATED FROM THE CATHETER, HOWEVER, WAS ABLE TO BE RETRIEVED VIA SNARE. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15662337 ↗
• MalfunctionAug 20, 2022Material Rupture; Improper or Incorrect Procedure or Method; Material Rupture; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, 98% STENOSED LESION IN THE LEFT EXTERNAL ILIAC ARTERY. A 9X100MM ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM (SESS) WAS IMPLANTED WITHOUT ISSUE. DURING POST-DILATATION, WHILE ADVANCING WITH A 9X80MM ARMADA 35 BALLOON DILATATION CATHETER (BDC), THE PHYSICIAN PUSHED THE EDGE OF THE TIP OF THE ARMADA BDC AGAINST THE IMPLANTED ABSOLUTE PRO STENT CAUSING RESISTANCE BETWEEN THE DEVICES, AND THE ABSOLUTE PRO SESS BECAME STRETCHED. THE BDC WAS REMOVED AND REPLACED WITH A VIATRAC 14 PLUS PERIPHERAL BALLOON DILATATION CATHETER TO COMPLETE POST-DILATATION, WHEN THE BALLOON WAS INFLATED TO 24 ATMOSPHERES (ATM) AND RUPTURED ON THE FIRST INFLATION. THE VIATRAC BDC WAS REMOVED AND THE ARMADA BDC WAS RE-INSERTED TO SUCCESSFULLY COMPLETE THE POST-DILATATION. THE STRETCHED ABSOLUTE SESS REMAINS IMPLANTED. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15263279 ↗
• MalfunctionApr 26, 2021Material Rupture; Material Rupture

  USER FACILITY MEDWATCH REPORT RECEIVED THAT STATES: THE PATIENT HAD LEFT SUBCLAVIAN STENOSIS INVOLVING THE OSTIUM OF THE LEFT VERTEBRAL ARTERY . TO INDUCE RETROGRADE VERTEBRAL FLOW THROUGHOUT THE CASE, THE OPERATING PHYSICIAN OPTED TO PLACE A MOMA DEVICE WITHIN THE PROXIMAL SUBCLAVIAN ARTERY. THE DISTAL BALLOON WAS REMOVED AND ONLY THE PROXIMAL OCCLUSION WAS PERFORMED. AFTER STABILIZING THE MOMA DEVICE, THE PROXIMAL BALLOON WAS INFLATED IN THE VERY PROXIMAL LEFT SUBCLAVIAN ENSURING RETROGRADE FLOW TO THE LEFT VERTEBRAL. THE LEFT SUBCLAVIAN ARTERY WAS SUCCESSFULLY STENTED WITH A RX HERCULINK ELITE 7 X 15 STENT. UPON REMOVAL OF THE INITIAL HERCULINK STENT BALLOON THE BALLOON RUPTURED AND A VERY SMALL PORTION OF THE DISTAL BALLOON MAY HAVE BEEN SHEARED OFF BY MOMA DEVICE. HOWEVER, NO EVIDENCE OF EMBOLIZATION WAS NOTED. THE PATIENT TOLERATED THE PROCEDURE WELL WITHOUT COMPLICATIONS AND WAS NOTIFIED BY THE PHYSICIAN. FDA SAFETY REPORT ID # (B)(4). THE DEVICE RETURNED TO ABBOTT WITH THE USER FACILITY MEDWATCH REPORT WAS A 7X20 MM VIATRAC 14 BALLOON DILATATION CATHETER. ANALYSIS OF THE DEVICE OBSERVED A BALLOON RUPTURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11729617 ↗