Symmetry™ M001103850Recalls & reported problems
Boston Scientific Corporation · Balloon Dilatation Catheter · Class 2
All models of Symmetry (13)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729181910), received between Aug 8, 2019 and Dec 16, 2019 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Material Integrity Problem” (1 report).
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
Device problems
- Material Integrity Problem1
- Material Rupture1
Patient problems
- No Consequences Or Impact To Patient1
- No Patient Involvement1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 16, 2019Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT A BALLOON DAMAGE OCCURRED. A 5.5 X 20 X 90CM SYMMETRY BALLOON WAS SELECTED FOR USE. DURING UNPACKING, IT WAS NOTED THAT THE BALLOON WAS BROKEN. THE DEVICE NEVER WENT INTO THE PATIENT'S BODY. THERE WERE NO PATIENT COMPLICATIONS REPORTED.
Patient problems: No Patient Involvement
MAUDE report 9473587 ↗MalfunctionAug 8, 2019Material Rupture; Material Rupture
IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE VESSEL OF THE UPPER ARM. A 5.5-2/4T/90 SYMMETRY BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE 3RD INFLATION AT 10 ATMOSPHERES FOR 5 SECONDS, 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 8875654 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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