Sterling™ H74939032701210Recalls & 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
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729845508), received between Jun 29, 2023 and Jun 29, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Rupture” (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 16, 2026.
Most reported problems
Device problems
- Material Rupture1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 29, 2023Material Rupture; Material Rupture
IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE PATIENT PRESENTED WITH PERIPHERAL ARTERY DISEASE AND UNDERWENT LEFT LEG ANGIOPLASTY. THE 70% STENOSED TARGET LESION WAS LOCATION IN THE NON-TORTUOUS AND MODERATELY CALCIFIED MID SUPERFICIAL FEMORAL ARTERY (SFA). AFTER PLACING A 7FR SHEATH OVER THE BIFURCATION DOWN THE LEFT LEG TO MID SFA, ATHERECTOMY WAS PERFORMED VIA 2.40 JETSTREAM WITH 014 THRUWAY GUIDEWIRE. THE JETSTREAM WAS REMOVED AND A 7.0X120X150 STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE INITIAL INFLATION AT 10 ATMOSPHERES FOR 30 SECONDS, INFLATION PRESSURE WAS SUDDENLY LOST AND CONTRAST WAS WASHED DOWN THE LEG. UPON INSPECTION AFTER REMOVAL, IT WAS NOTED THAT THE BALLOON HAD POPPED. ANOTHER 7.0X120X150 STERLING BALLOON CATHETER WAS ADVANCED AND INFLATED TO ATMOSPHERES COMPLETING THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17232901 ↗
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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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