Symmetry™ M001103270Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 08714729181798), received between Nov 19, 2018 and Aug 11, 2026 — classified as 19 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (19 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 11, 2026Material Rupture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50209653 ↗
• MalfunctionJan 2, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED SUPERFICIAL FOREAM VESSEL. A SYMMETRY BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING FIRST INFLATION AT 10 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 21057332 ↗
• MalfunctionNov 12, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 95% STENOSED TARGET LESION WAS LOCATED IN A SHUNT IN THE MODERATELY TORTUOUS AND MILDLY CALCIFIED CEPHALIC VEIN. A 4.0-4/4T/90 SYMMETRY BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE FIRST INFLATION AT 10 ATMOSPHERES FOR 60 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS IN GOOD CONDITION AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20664127 ↗
• MalfunctionMay 1, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AD SEVERELY CALCIFIED FOREARM CEPHALIC VEIN. A SYMMETRY BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING SECOND INFLATION AT 16 ATMOSPHERES FOR 30 SECONDS, THE BALLOON RUPTURED VERTICALLY. THE DEVICE WAS REMOVED USING NORMAL METHOD WITHOUT ISSUE AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS IN GOOD CONDITION POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19220920 ↗
• MalfunctionJan 11, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 75% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED ANASTOMOTIC VEIN OF NEAR LEFT FOREARM. A SYMMETRY BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING SECOND INFLATION AT 15 ATMOSPHERES FOR 30 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED USING NORMAL METHOD WITHOUT ISSUE AND THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO COMPLICATIONS REPORTED AND THE PATIENT WAS IN GOOD CONDITION POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18491349 ↗
• MalfunctionOct 2, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN A SHUNT IN A MILDLY TORTUOUS AND MILDLY CALCIFIED VESSEL IN THE FOREARM. AN SV/4.0-4/4T/90 SYMMETRY BALLOON CATHETER WAS ADVANCED FOR DILATATION; HOWEVER, DURING THE FIRST INFLATION AT 6 ATMOSPHERES FOR 30 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT INJURIES REPORTED AND THE PATIENT WAS IN CONDITION GOOD POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17857910 ↗
• MalfunctionSep 8, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED FOREARM CEPHALIC VEIN. AN SV/4.0-4/4T/90 SYMMETRY BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING SECOND INFLATION AT 15 ATMOSPHERES FOR 30 SECONDS, THE BALLOON RUPTURED AND VERTICALLY SEPARATED. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED, AND THE PATIENT CONDITION WAS GOOD POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17709661 ↗
• MalfunctionFeb 10, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED FOREARM SHUNT BLOOD VESSEL. A 4.0-4/4T/90 SYMMETRY BALLOON CATHETER WAS ADVANCED FOR DILATATION, HOWEVER, DURING THE PROCEDURE THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. IT WAS FURTHER REPORTED THAT THE BALLOON RUPTURED DURING THE SECOND INFLATION AT 15 ATMOSPHERES FOR 30 SECONDS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16350694 ↗
• MalfunctionMay 24, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 75% STENOSED TARGET LESION WAS LOCATED IN A SHUNT IN AMILDLY TORTUOUS AND MODERATELY CALCIFIED VESSEL. A SV/4.0-4/4T/90 SYMMETRY BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, ON THE SECOND INFLATION AT 18 ATMOSPHERES FOR 30 SECONDS, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND NO PATIENT COMMUNICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11872830 ↗
• MalfunctionDec 17, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 4.0-4/4T/90 SYMMETRY BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE FOURTH INFLATION AT 10 ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11032747 ↗
• MalfunctionDec 9, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN A SHUNT IN A MODERATELY TORTUOUS AND MILDLY CALCIFIED FOREARM VESSEL. A 4.0-4/4T/90 SYMMETRY BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INITIAL INFLATION AT 10 ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED AND THE PATIENT STATUS WAS GOOD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10974918 ↗
• MalfunctionSep 16, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MILDLY CALCIFIED VESSEL. A 4.0-4/4T/90 SYMMETRY BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION AT 16 ATMOSPHERES FOR 30 SECONDS, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10541453 ↗
• MalfunctionAug 11, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE BALLOON WAS TORN. A 4.5-4/4T/90 SYMMETRY BALLOON CATHETER WAS SELECTED FOR DILATION. HOWEVER, THE GUIDEWIRE WAS STUCK INSIDE THE SHAFT AROUND THE BALLOON PART AND THE CATHETER COULD NOT BE PLACED ON THE WIRE. ANOTHER 4.0-4/4T/90 SYMMETRY BALLOON CATHETER WAS SELECTED BUT THE BALLOON WAS TORN DURING PREPARATION. 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 10390243 ↗
• MalfunctionMay 27, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED VESSEL. A 4.0-4/4T/90 SYMMETRY BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, ON INITIAL INFLATION AT 16 ATMOSPHERES FOR 30 SECONDS, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10094706 ↗
• MalfunctionMar 5, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED VESSEL. A 4.0-4/4T/90 SYMMETRY BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE FIFTH INFLATION AT 15 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 9795341 ↗
• MalfunctionDec 12, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED VESSEL. A 4.0-4/4T/90 SYMMETRY BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE FIRST INFLATION AT 15 ATMOSPHERES FOR 30 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED FROM THE PATIENT'S BODY AND 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 9462539 ↗
• MalfunctionAug 23, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. VASCULAR ACCESS WAS OBTAINED BY VENOUS RETROGRADE APPROACH. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED VESSEL OF THE FOREARM. AFTER A GUIDE WIRE PASSED THROUGH THE LESION, A 4.0-4/4T/90 SYMMETRY BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, ON INITIAL INFLATION, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH A NON-BSC BALLOON CATHETER. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8924346 ↗
• MalfunctionFeb 11, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN A SHUNT IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED VESSEL. A 4.0-4/4T/90CM SYMMETRY BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING THE FIRST INFLATION AT 15 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 8328782 ↗
• MalfunctionNov 19, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN A SHUNT IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED VESSEL. A 4.0-4/4T/90 SYMMETRY BALLOON CATHETER WAS ADVANCED FOR PRE-DILATION. HOWEVER, ON INITIAL INFLATION AT 8 ATMOSPHERES, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER 4.0-4/4T/90 SYMMETRY BALLOON CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8084852 ↗