Sterling™ H74939032502090Recalls & reported problems
Boston Scientific Corporation · PTA Balloon Dilatation Catheter · Class 2
All models of Sterling (153)
Data updated Oct 18, 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 08714729845386), received between Aug 19, 2019 and Aug 19, 2019 — 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 18, 2026.
Most reported problems
Device problems
- Material Rupture1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 19, 2019Material Rupture; Material Rupture
IT WAS REPORTED THAT THE BALLOON RUPTURED. A 5.0X200X90 STERLING BALLOON CATHETER AND A 5.0X220X90 STERLING BALLOON CATHETER WERE SELECTED FOR A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY OF THE HEAVILY CALCIFIED SUPERFICIAL FEMORAL ARTERY. DURING THE PROCEDURE INSIDE THE PATIENT, BOTH BALLOONS RUPTURED. THE 5.0X200X90 STERLING BALLOON RUPTURED AT 12ATM AND THE 5.0X220X90 STERLING BALLOON RUPTURED AT 13ATM. THE PROCEDURE WAS COMPLETED WITH ANOTHER STERLING BALLOON CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8906434 ↗
Other Catheter, angioplasty, peripheral, transluminal devices
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- Coyote™ ES H74939135202010Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal437 reports
- Coyote™ ES H74939135304010Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal384 reports
- Coyote™ ES H74939135404010Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal293 reports
- Coyote™ ES H74939134152010Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal279 reports
- Coyote™ H74939185202210Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal200 reports
- Coyote™ ES H74939135254010Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal127 reports
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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