Sterling™ H74939032402290Recalls & 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 08714729860327), received between Apr 24, 2019 and Apr 24, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Puncture/Hole” (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 Puncture/Hole1
Patient problems
- No Consequences Or Impact To Patient1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 24, 2019Material Puncture/Hole; Material Puncture/Hole
IT WAS REPORTED THAT SHAFT PERFORATION OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT SUPERFICIAL FEMORAL ARTERY. AFTER INSERTION OF A NON-BSC GUIDE WIRE, A 4.0X220X90 (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING IMAGING, THE WIRE APPEARED TO BE COMING OUT OF THE DEVICE. THE DEVICE WAS REMOVED AND WAS INFLATED OUTSIDE OF THE PATIENT. IT WAS THEN NOTED THAT THE CATHETER HAD THREE HOLES. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT STATUS WAS STABLE.
Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient
MAUDE report 8545118 ↗
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- Coyote™ ES H74939134152010Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal279 reports
- Coyote™ H74939185202210Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal200 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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