Symmetry™ M001103340Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 08714729181972), received between Sep 5, 2018 and Jul 2, 2024 — classified as 16 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (13 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 16, 2026.

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 2, 2024Material Puncture/Hole; Adverse Event Without Identified Device or Use Problem; Material Puncture/Hole; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SHAFT HOLE OCCURRED. A 6.0-4/4T/90 SYMMETRY BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON DID NOT PROPERLY INFLATE UPON SECOND INFLATION. AFTER REMOVAL, THERE WAS A HOLE NOTED AROUND THE MIDDLE SHAFT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19660232 ↗
• MalfunctionMar 23, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 95% STENOSED TARGET LESION WAS LOCATED IN AN ARTERIOVENOUS FISTULA IN THE MODERATELY TORTUOUS AND MILDLY CALCIFIED VEIN. A 6.0-4/4T/90 SYMMETRY BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE SECOND INFLATION AT 6 ATMOSPHERES FOR 30 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT INJURIES NOR COMPLICATIONS REPORTED AND THE PATIENT WAS IN GOOD CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13866604 ↗
• MalfunctionNov 12, 2021Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 05-NOV-2021. IT WAS REPORTED THAT TIP LEAK AND BALLOON INFLATION FAILURE OCCURRED. THE 95% STENOSED TARGET LESION WAS LOCATED IN AN ARTERIOVENOUS FISTULA IN A MILDLY TORTUOUS AND MILDLY CALCIFIED VEIN SIDE. A /6.0-4/4T/90 SYMMETRY BALLOON CATHETER WAS ADVANCED FOR DILATATION; HOWEVER, DURING THE FIRST INFLATION, IT WAS NOTICED THRU FLUOROSCOPY THAT THE RADIOPAQUE SUBSTANCE WAS LEAKING NEAR THE TIP PART OF THE BALLOON AND THE PRESSURE WAS UNABLE TO BE APPLIED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT INJURIES REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED BALLOON PINHOLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12807257 ↗
• MalfunctionOct 18, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. TWO SV/6.0-4/4T/90 SYMMETRY BALLOON CATHETERS WERE ADVANCED FOR DILATATION. HOWEVER, DURING THE PROCEDURE, BOTH BALLOONS WERE RUPTURED. THE PROCEDURE WAS COMPLETED WITH DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12648658 ↗
• MalfunctionOct 18, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. TWO SV/6.0-4/4T/90 SYMMETRY BALLOON CATHETERS WERE ADVANCED FOR DILATATION. HOWEVER, DURING THE PROCEDURE, BOTH BALLOONS WERE RUPTURED. THE PROCEDURE WAS COMPLETED WITH DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12648570 ↗
• MalfunctionFeb 10, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 6.0-4/4T/90 SYMMETRY BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING FIRST INFLATION AT 6 ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11311175 ↗
• MalfunctionDec 24, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 6.0-4/4T/90 SYMMETRY BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE FIRST INFLATION AT 8 ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT'S BODY AND A PINHOLE WAS NOTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS GOOD POST PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11072284 ↗
• MalfunctionApr 3, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 6.0-4/4T/90 SYMMETRY BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, ON THE SECOND INFLATION AT 13 ATMOSPHERES FOR 10 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9920448 ↗
• MalfunctionMar 27, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A /6.0-4/4T/90 SYMMETRY BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, THE BALLOON RUPTURED BEFORE REACHING THE NOMINAL PRESSURE DURING FIRST DILATATION. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9892310 ↗
• MalfunctionDec 24, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN A MODERATELY TORTUOUS AND MODERATELY CALCIFIED VESSEL. A 6.0-4/4T/90 SYMMETRY BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE FIRST INFLATION AT 16 ATMOSPHERES FOR 30 SECONDS, 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 9515013 ↗
• MalfunctionJul 1, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. VASCULAR ACCESS WAS OBTAINED BY UTILIZING A VENOUS RETROGRADE APPROACH. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED VESSEL OF THE FOREARM. AFTER CROSSING THE GUIDEWIRE, A 6.0-4/4T/90 SYMMETRY BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, UPON INITIAL INFLATION THE BALLOON RUPTURED. ANOTHER OF SAME DEVICE WAS USED, AND DILATATION WAS PERFORMED SLOWLY. THE FLOW RECOVERED, AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8749311 ↗
• MalfunctionApr 17, 2019Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN A DIALYSIS GRAFT IN THE UPPER EXTREMITY . AN SV/6.0-4/4T/90 SYMMETRY BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, POST-DILATATION, IT WAS NOTED THAT THE SHAFT BROKE ON A PORTION OUTSIDE OF THE PATIENT'S BODY. DILATION WAS FINISHED AT THAT POINT, SO THE DEVICE WAS REMOVED FROM THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8524460 ↗
• MalfunctionApr 8, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN A SHUNT IN AN UPPER ARM VESSEL. A 6.0-4/4T/90 SYMMETRY BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, 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 8491430 ↗
• MalfunctionMar 18, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS FOREARM SHUNT. A 6.0-4/4T/90CM SYMMETRY BALLOON CATHETER WAS ADVANCED FOR DILATION; HOWEVER, UPON INFLATION THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8430858 ↗
• MalfunctionJan 21, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN A SHUNT IN A MODERATELY TORTUOUS AND MODERATELY CALCIFIED VESSEL. A 6.0-4/4T/90 SYMMETRY BALLOON CATHETER WAS ADVANCED FOR PRE-DILATION. HOWEVER, DURING THE 7TH INFLATION AT 20 ATMOSPHERES FOR 30 SECONDS, THE BALLOON RUPTURED. SINCE THE LESION WAS SUFFICIENTLY DILATED, THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8265648 ↗
• MalfunctionSep 5, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. VASCULAR ACCESS WAS OBTAINED UTILIZING A VENOUS RETROGRADE APPROACH. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED VESSEL OF THE LEFT FOREARM. AFTER A GUIDE WIRE CROSSED THE LESION, A 6.0-4/4T/90 SYMMETRY BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION, THE BALLOON RUPTURED. THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT'S BODY AND THE PROCEDURE WAS COMPLETED WITH ANOTHER SYMMETRY BALLOON CATHETER. FLOW RECOVERY WAS THEN ACHIEVED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7848622 ↗