Symmetry™ M001103210Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 08714729181675), received between Dec 13, 2018 and Aug 13, 2024 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (6 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 13, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 95% STENOSED TARGET LESION WERE ALL ANASTOMOTIC LESIONS IN THE SAME PATIENT LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED FOREARM LOOP SHUNT. A TOTAL OF FOUR SYMMETRY BALLOON CATHETERS WERE USED IN THIS PROCEDURE WITH TWO IN THE SIZES 3.5-4/4T/90 AND TWO 3.0-4/4T/90. AS THE 3.5-40 DID NOT WIDEN, THEY WERE CHANGED TO 3.0-40 AND AN ATTEMPT WAS MADE TO INCREASE THE PRESSURE, BUT IT ALSO DID NOT WIDEN. DURING THE PROCEDURE, THE BALLOONS RUPTURED STARTING WITH THE FIRST DEVICE ON THE SECOND INFLATION AT 10 ATMOSPHERES, THE SECOND DEVICE ON THE FIRST INFLATION AT 10 ATMOSPHERES, THE THIRD DEVICE ON THE FIRST INFLATION AT 8 ATMOSPHERES, AND THE FOURTH DEVICE ON THE FIRST INFLATION AT 10 ATMOSPHERES. ALL FOUR BALLOONS WERE INFLATED FOR 30 SECONDS BEFORE THEY BURST. THE DEVICES WERE SUCCESSFULLY REMOVED WITH THE RUPTURES NOTED TO BE VERTICALLY SEPARATED IN SHAPE BEFORE THEY WERE REPLACED FOR ANOTHER OF THE SAME MODEL TO COMPLETE THE PROCEDURE. NO COMPLICATIONS REPORTED, AND PATIENT STATUS WAS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19977360 ↗
• MalfunctionAug 13, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 95% STENOSED TARGET LESION WERE ALL ANASTOMOTIC LESIONS IN THE SAME PATIENT LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED FOREARM LOOP SHUNT. A TOTAL OF FOUR SYMMETRY BALLOON CATHETERS WERE USED IN THIS PROCEDURE WITH TWO IN THE SIZES 3.5-4/4T/90 AND TWO 3.0-4/4T/90. AS THE 3.5-40 DID NOT WIDEN, THEY WERE CHANGED TO 3.0-40 AND AN ATTEMPT WAS MADE TO INCREASE THE PRESSURE, BUT IT ALSO DID NOT WIDEN. DURING THE PROCEDURE, THE BALLOONS RUPTURED STARTING WITH THE FIRST DEVICE ON THE SECOND INFLATION AT 10 ATMOSPHERES, THE SECOND DEVICE ON THE FIRST INFLATION AT 10 ATMOSPHERES, THE THIRD DEVICE ON THE FIRST INFLATION AT 8 ATMOSPHERES, AND THE FOURTH DEVICE ON THE FIRST INFLATION AT 10 ATMOSPHERES. ALL FOUR BALLOONS WERE INFLATED FOR 30 SECONDS BEFORE THEY BURST. THE DEVICES WERE SUCCESSFULLY REMOVED WITH THE RUPTURES NOTED TO BE VERTICALLY SEPARATED IN SHAPE BEFORE THEY WERE REPLACED FOR ANOTHER OF THE SAME MODEL TO COMPLETE THE PROCEDURE. NO COMPLICATIONS REPORTED, AND PATIENT STATUS WAS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19977345 ↗
• MalfunctionJul 22, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN AN ARTERIOVENOUS ANASTOMOSIS IN A MODERATELY TORTUOUS AND MODERATELY CALCIFIED CEPHALIC VEIN. A 3.0-4/4T/90 SYMMETRY BALLOON CATHETER WAS ADVANCED FOR DILTATION. HOWEVER, DURING THE THIRD INFLATION AT 8 ATMOSPHERES, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12209723 ↗
• MalfunctionDec 13, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND NON-CALCIFIED CEPHALIC VEIN. A 3.0-4/4T/90 SYMMETRY BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THIRD INFLATION AT 15 ATMOSPHERES FOR 3 MINUTES, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS IN GOOD CONDITION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10999198 ↗
• MalfunctionMay 21, 2020Inflation Problem; Inflation Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 28APR2020. IT WAS REPORTED THAT BALLOON INFLATION FAILURE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN AN ANASTOMOSIS SHUNT IN A SEVERELY TORTUOUS AND MODERATELY CALCIFIED VESSEL. A 3.0-4/4T/90 SYMMETRY BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE PROCEDURE, THE BALLOON FAILED TO INFLATE DESPITE APPLICATION OF PRESSURE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED BALLOON PINHOLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10078701 ↗
• MalfunctionDec 11, 2019Leak/Splash; Leak/Splash

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 28-NOV-2019. IT WAS REPORTED THAT BALLOON LEAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND MILDLY CALCIFIED VEIN. A 3.0-4/4T/90 SYMMETRY BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, THE PRESSURE DID NOT INCREASE DURING FIRST INFLATION. PHYSICIAN REMOVED AND CHECKED THE BALLOON, IT WAS CONFIRMED THAT A LIQUID LEAKAGE WAS SEEN IN THE TIP SIDE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED BALLOON PINHOLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9454040 ↗
• MalfunctionJun 19, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 3.0-4/4T/90 SYMMETRY BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION AT 12 ATMOSPHERES, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8714846 ↗
• MalfunctionDec 13, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURED OCCURRED. THE TARGET LESION WAS LOCATED IN A SHUNT IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED VESSEL. AN SV/3.0-4/4T/90 SYMMETRY BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, UPON THE FIRST INFLATION AT 15 ATMOSPHERES, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8162144 ↗