Sterling™ H74939031452010Recalls & reported problems
Boston Scientific Corporation · PTA Balloon Dilatation Catheter · Class 2
All models of Sterling (153)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729757030), received between Apr 8, 2020 and Feb 20, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (2 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.
Reports received per month
Most reported problems
Device problems
- Material Rupture2
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Patient Involvement1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 20, 2026Material Rupture
IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE INTERNAL CAROTID ARTERY. A 4.5MMX20MMX135CM (4F) STERLING MR BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, 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 AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24404984 ↗MalfunctionJun 29, 2021Material Rupture; Material Rupture
IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 4.5MMX20MMX135CM STERLING BALLOON CATHETER WAS ADVANCED FOR DILATIONAND A SLIGHT CALCIFICATION WAS NOTED. HOWEVER, DURING INFLATION AT 6 ATMOSPHERES, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE AND NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12089112 ↗MalfunctionApr 8, 2020Break; Break
IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 4.5MMX20MMX135CM (4F) STERLING BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, DURING PREPARATION WHEN THE DEVICE WAS PULLED OUT OF THE HOOP, THE DEVICE CAME APART. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS FINE.
Patient problems: No Patient Involvement
MAUDE report 9938182 ↗
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- WATCHMAN™ TruSeal™ Access System M635TU70020Boston Scientific Corporation · Catheter, percutaneous1 recall11 deaths217 reports
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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