Sterling™ H74939031402210Recalls & 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729859291), received between Mar 17, 2021 and Mar 17, 2021 — classified as 1 injury.
The most frequently reported specific device problem is “Entrapment of Device” (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
- Entrapment of Device1
- Material Deformation1
Patient problems
- Hematoma1
- Vomiting1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 17, 2021Entrapment of Device; Material Deformation; Entrapment of Device; Material Deformation
IT WAS REPORTED THAT FROZE ON WIRE OCCURRED; AND THE PATIENT EXPERIENCED VOMITING AND HEMATOMA. THE 80-95% STENOSED, 300MM, COMPLEX MULTILEVEL HEAVY CALCIUM TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND CALCIFIED FEMORAL POPLITEAL ARTERY. A 6F NON-BOSTON SCIENTIFIC SHEATH AND A 300CM, 8CM V-18 CONTROL WIRE WERE PLACED. A 4.0 MM X 220 MM X 150 CM STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. THE BALLOON WAS INFLATED THRICE AT 14 ATMOSPHERES FOR 2 MINUTES. THE DEVICE WAS THEN FULLY DEFLATED AND THE DEVICE WAS ATTEMPTED TO BE REMOVED OFF THE WIRE. THE PHYSICIAN PIN PULLED THE DEVICE OR ATTEMPTED TO BE PIN PULLED OFF WIRE AND IT WAS NOTICED THAT THE BALLOON PROLAPSED AND THE HYPOTUBE WAS BENT. THE PHYSICIAN REMOVED THE ENTIRE SYSTEM INCLUDING THE SHEATH. THE PATIENT HAD HEMATOMA AND VOMITING. THE PHYSICIAN PERFORMED A SUPERCIAL FEMORAL AFTERY (SFA) RECANULIZATION AND A COMPUTERIZED TOMOGRAPHY SCAN (CT SCAN) WAS PERFORMED TO RULE OUT RETROPERITONEAL BLEED OR HEMATOMA (RPH). THE PROCEDURE WAS COMPLETED. THE PATIENT FULLY RECOVERED. IT WAS FURTHER REPORTED THAT THE HEMATOMA WAS LOCATED IN THE GROIN. THE RETROPERITONEAL BLEED WAS RULED OUT. THE CAUSED OF PATIENT'S VOMIT
Patient problems: Hematoma; Vomiting
MAUDE report 11507773 ↗
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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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