SymmetryRecalls & reported problems across all models
Boston Scientific Corporation · 13 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 134
- Deaths reported
- 0
- Injuries reported
- 7
- Recalls
- 0
We found 13 models of Symmetry by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 134 adverse event reports in the FDA's MAUDE database, received between Aug 24, 2018 and Aug 11, 2026 — classified as 7 injuries, 127 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (121 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Symmetry problems
Device problems
- Material Rupture121
- Difficult to Remove5
- Break4
- Detachment of Device or Device Component4
- Inflation Problem4
- Adverse Event Without Identified Device or Use Problem3
- Entrapment of Device3
- Leak/Splash3
Patient problems
- No Clinical Signs, Symptoms or Conditions72
- No Consequences Or Impact To Patient59
- No Patient Involvement2
- Foreign Body In Patient1
- Hemorrhage/Blood Loss/Bleeding1
Symmetry models
13 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Symmetry™ M001103240Catheter, angioplasty, peripheral, transluminal33 reports
- Symmetry™ M001103270Catheter, angioplasty, peripheral, transluminal19 reports
- Symmetry™ M001103340Catheter, angioplasty, peripheral, transluminal16 reports
- Symmetry™ M001103320Catheter, angioplasty, peripheral, transluminal14 reports
- Symmetry™ M001103300Catheter, angioplasty, peripheral, transluminal13 reports
- Symmetry™ M001103860Catheter, angioplasty, peripheral, transluminal12 reports
- Symmetry™ M001103210Catheter, angioplasty, peripheral, transluminal8 reports
- Symmetry™ M001103330Catheter, angioplasty, peripheral, transluminal7 reports
- Symmetry™ M001103260Catheter, angioplasty, peripheral, transluminal4 reports
- Symmetry™ M001103310Catheter, angioplasty, peripheral, transluminal4 reports
- Symmetry™ M001103850Catheter, angioplasty, peripheral, transluminal2 reports
- Symmetry™ M001103230Catheter, angioplasty, peripheral, transluminal1 report
- Symmetry™ M001103290Catheter, angioplasty, peripheral, transluminal1 report
Recent Symmetry adverse event reports
The 15 most recent reports across all models, 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 ↗MalfunctionFeb 16, 2026Material Rupture
IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED FOREARM SHUNT VESSEL. A SYMMETRY? BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE PROCEDURE, THE BALLOON RUPTURED AFTER THE THIRD INFLATION AT 10 ATMOSPHERES FOR 60 SECONDS. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24349881 ↗MalfunctionFeb 10, 2026Material Rupture
IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND NON-CALCIFIED SHUNT. A 5.0-4/4T/90 SYMMETRY BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON FIRST INFLATION AT 12 ATMOSPHERES FOR 30 SECONDS. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24309259 ↗MalfunctionJan 19, 2026Material Rupture
IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN A SEVERELY TORTUOUS AND NON-CALCIFIED RADIAL ANTECUBITAL VEIN. A 4.5-4/4T/90 SYMMETRY BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING THE INITIAL INFLATION AT 10 ATMOSPHERES FOR ONE MINUTE, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24108173 ↗MalfunctionDec 4, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED VESSEL IN THE LEFT ELBOW. A 5.5-40/4T/90 SYMMETRY BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE FIRST INFLATION AT 10 ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED USING NORMAL METHOD WITHOUT ISSUE AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23716950 ↗MalfunctionSep 16, 2025Break; Difficult to Remove; Material Rupture; Adverse Event Without Identified Device or Use Problem; Break; Difficult to Remove; Material Rupture; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED SHUNT VESSELS. A 5.0-4/4T/90 SYMMETRY BALLOON WAS SELECTED FOR USE IN A VASCULAR ACCESS INTERVENTION THERAPY. THE SYMMETRY BALLOON WAS INFLATED AT THE STENOTIC SITE. AFTERWARDS, WHEN ATTEMPTING TO PULL OUT THE BALLOON CATHETER, RESISTANCE WAS ENCOUNTERED, AND THE BALLOON RUPTURE OCCURRED AT THE TIP OF THE NON-BOSTON SCIENTIFIC SHEATH. THE SHAFT AND BALLOON SEPARATED; HOWEVER, THE SHEATH AND THE RUPTURED BALLOON WERE RECOVERED TOGETHER WITH NO FRAGMENTS REMAINING IN THE BODY. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23065958 ↗MalfunctionJun 30, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 905 STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED CEPHALIC VEIN. A SYMMETRY BALLOON CATHETER WAS SELECTED FOR USE. DURING THE PROCEDURE, THE BALLOON RUPTURED AFTER THE FIRST INFLATION AT 15 ATMOSPHERES FOR 30 SECONDS. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM, AND THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22366472 ↗MalfunctionMar 27, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY CALCIFIED FOREARM SHUNT. A 4.5-4/4T/90 SYMMETRY BALLOON WAS ADVANCED FOR DILATION. HOWEVER, DURING THE SECOND INFLATION AT ABOUT 8 ATMOSPHERES FOR 30 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT, AND THE PATIENT WAS IN GOOD CONDITION POST-PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21706203 ↗MalfunctionMar 19, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT THE BALLOON RUPTURE OCCURRED. THE 75% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED VENOUS ANASTOMOSIS SITE OF THE LEFT EAR. A SYMMETRY BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON SECOND INFLATION AT 8 ATMOSPHERES FOR 2 MINUTES. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS IN GOOD CONDITION AFTER THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21643490 ↗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 ↗MalfunctionOct 22, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN A VESSEL. A 3.5-4/4T/90 SYMMETRY BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING INFLATION AT BELOW NOMINAL PRESSURE, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED USING NORMAL METHOD WITHOUT ISSUE AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS IN GOOD CONDITION POST PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20508510 ↗InjuryOct 17, 2024Break; Difficult to Remove; Material Rupture; Break; Difficult to Remove; Material Rupture
IT WAS REPORTED THAT BALLOON RUPTURE AND CATHETER SEPARATION OCCURRED WHICH REQUIRES ADDITIONAL INTERVENTION. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED RADIAL ARTERY. A 3.5-4/4T/90 SYMMETRY BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE PROCEDURE, THE NON-BOSTON SCIENTIFIC SHEATH WAS PLACED IN THE VEIN. HOWEVER, UPON INFLATION AT 17 ATMOSPHERES BEYOND ANASTOMOSIS, THE BALLOON RUPTURED, AND THE BALLOON PART GOT SEPARATED INSIDE THE CATHETER. UPON REMOVAL, RESISTANCE WAS FELT AND THE DEVICE GOT CAUGHT ON THE SHEATH. CONSEQUENTLY, THE DEVICE WAS REMOVED SURGICALLY AS A SINGLE UNIT WITH THE SHEATH. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20471209 ↗MalfunctionOct 16, 2024Inflation Problem; Inflation Problem
REPORTABLE BASED ON THE DEVICE ANALYSIS COMPLETED ON 1 OCT 2024. IT WAS REPORTED THAT BALLOON PINHOLE AT THE DISTAL MARKERBAND OCCURRED. THE 75% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS VESSEL. A 3.5-4/4T/90 SYMMETRY BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE PROCEDURE, INITIAL INFLATION PRESSURE DIDN'T CHANGE. THE DEFLATOR INDICATED THE BALLOON CAUSED THE ISSUE. INSTEAD OF RUPTURING, PRESSURE LEAKAGE SEEMS TO BE THE PROBLEM. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED, AND THE PATIENT WAS IN GOOD CONDITION AFTER THE PROCEDURE. HOWEVER, PRODUCT ANALYSIS REVEALED PINHOLE LOCATED APPROXIMATELY AT THE DISTAL MARKERBAND.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20465380 ↗MalfunctionSep 10, 2024Material Rupture; Adverse Event Without Identified Device or Use Problem; Material Rupture; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND NON-CALCIFIED CEPHALIC VEIN OF THE FOREARM. A 3.5-4/4T/90 SYMMETRY BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED IN A VERTICAL FORM UPON THIRD INFLATION AT 15 ATMOSPHERES FOR 30 SECONDS. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEMS, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS IN GOOD CONDITION AFTER THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20186384 ↗
Other Boston Scientific Corporation products
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Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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