Sterling™ H74939031302210Recalls & 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729859208), received between Oct 26, 2022 and Oct 26, 2022 — classified as 1 injury.
The most frequently reported specific device problem is “Break” (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
- Break1
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.
InjuryOct 26, 2022Break; Break
IT WAS REPORTED VIA FACILITY MEDWATCH# REPORT MW5112057 THAT A SHAFT BREAK OCCURRED RESULTING IN SURGICAL INTERVENTION. THE 99% STENOSED TARGET LESION WITH A BEND OF <45 DEGREES WAS LOCATED IN THE NON-TORTUOUS AND SEVERELY CALCIFIED ANTERIOR TIBIAL VESSEL OF THE RIGHT LEG. A 3.0MMX220MMX150CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. AFTER DILATATION, THE BALLOON CATHETER WAS WITHDRAWN; HOWEVER, IT WAS DISCOVERED THAT THE BALLOON AND PART OF THE CATHETER WHERE IT IS MOUNTED TO WERE BROKEN OFF AND REMAINED IN THE PATIENT'S BLOOD VESSEL. THE REST OF THE CATHETER AND SHEATHS WERE REMOVED FROM THE PATIENT'S LEFT GROIN AND PRESSURE WAS HELD UNTIL HEMOSTASIS WAS ACHIEVED. THE PATIENT WAS TAKEN TO THE OPERATING ROOM FOR SURGICAL REMOVAL OF FRACTURED CATHETER AND POSSIBLE BYPASS SURGERY. EVENTUALLY, THE FRACTURED PORTION WAS SUCCESSFULLY REMOVED BY SURGICAL REMOVAL. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS THE PATIENT STATUS WAS STABLE POST-PROCEDURE AND WAS DISCHARGED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15675114 ↗
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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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