Symmetry™ Stiff Shaft M001105170Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 08714729182665), received between Apr 24, 2019 and Mar 24, 2021 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (8 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.

• MalfunctionMar 24, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN A SHUNT IN THE LEFT HAND. A 3.5-10/4T/90 SYMMETRY BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION AT NOMINAL PRESSURE FOR A FEW SECONDS, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11562091 ↗
• MalfunctionNov 13, 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 SS/3.5-10/4T/90 SYMMETRY BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, ON INITIAL INFLATION AT 15 ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT STATUS WAS GOOD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10837240 ↗
• MalfunctionApr 1, 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 3.5-10/4T/90 SYMMETRY STIFF SHAFT BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, ON INITIAL INFLATION AT 12 ATMOSPHERES FOR LESS THAN 30 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9909920 ↗
• MalfunctionOct 16, 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 ARTERY. A 3.5-10/4T/90 SYMMETRY STIFF SHAFT BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING FIRST INFLATION AT 4 ATMOSPHERES FOR 10 SECONDS, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT SERIOUS INJURY OR ADVERSE EVENT WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9196867 ↗
• MalfunctionJul 1, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN A MODERATELY TORTUOUS AND MILDLY CALCIFIED VESSEL. A 3.5-10/4T/90 SYMMETRY STIFF SHAFT BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE THIRD 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 8751503 ↗
• MalfunctionMay 25, 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 SEVERELY CALCIFIED ARTERIOVENOUS FISTULA. A 3.5-10/4T/90 SYMMETRY STIFF SHAFT BALLOON CATHETER WAS ADVANCED FOR PRE-DILATATION. HOWEVER, ON INITIAL INFLATION AT NEARLY 10 ATMOSPHERES FOR 10 SECONDS, THE BALLOON RUPTURED. SINCE THE LESION AREA WAS NOT COMPLETELY DILATED, PRE-DILATATION WAS PERFORMED AGAIN WITH ANOTHER 3.5 X 4 SYMMETRY BALLOON AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8643020 ↗
• MalfunctionMay 24, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN A SHUNT IN A MODERATELY TORTUOUS AND SEVERELY CALCIFIED VESSEL. A 3.5-10/4T/90 SYMMETRY BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE FIRST INFLATION AT NEAR 10 ATMOSPHERES, THE BALLOON RUPTURED. ANOTHER SYMMETRY DEVICE WAS USED TO PRE-DILATE THE LESION AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8642895 ↗
• MalfunctionApr 24, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED VESSEL. A 3.5-10/4T/90 SYMMETRY BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE FIRST INFLATION AT 14 ATMOSPHERES FOR 30 SECONDS, CONTRAST MEDIA WAS FOUND TO BE LEAKING AND THE PRESSURE COULD NOT BE MAINTAINED AND IT IMMEDIATELY DROPPED BELOW 10 ATMOSPHERES. PRESSURIZATION AND DEPRESSURIZATION WERE REPEATEDLY PERFORMED UP TO 14ATM SEVERAL TIMES, AND IT WAS FOUND OUT THAT THE BALLOON RUPTURED. AFTER THAT, 3.5X100MM SYMMETRY BALLOON CATHETER WAS UNPACKED, THEN THE PROCEDURE WAS CONTINUED AND IT WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8544177 ↗