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Sterling™ H74939032300210Recalls & 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 08714729860099), received between Aug 25, 2023 and Aug 25, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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

  • Detachment of Device or Device Component1
  • Difficult to Remove1
  • 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.

  • InjuryAug 25, 2023Difficult to Remove; Material Rupture; Detachment of Device or Device Component; Difficult to Remove; Material Rupture; Detachment of Device or Device Component

    IT WAS REPORTED THAT THE BALLOON BURST AND BECAME SHEARED OFF, REQUIRING A SNARE TO RETRIEVE. THIS 3.0X20X150 (4F) STERLING BALLOON WAS SELECTED FOR USE IN A RIGHT LOWER LIMB CRUSTAL VESSEL PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE. THERE WAS A SHORT FOCAL ANTERIOR TIBIAL (AT) OCCLUSION NOTED VIA DUPLEX ULTRASOUND. AFTER SUCCESSFUL ACCESS VIA THE COMMON FEMORAL ARTERY WITH A 5FR 11CM SHEATH, THE LESION WAS CROSSED WITH A GUIDEWIRE, THEN THIS BALLOON WAS INFLATED ACROSS THE OCCLUSION AT APPROXIMATELY NOMINAL PRESSURE, BUT IMMEDIATELY BURST. UPON ATTEMPTING TO REMOVE THE BALLOON, IT FELT LIKE IT WAS STICKING INSIDE THE SHEATH. IT EVENTUALLY WAS ABLE TO BE REMOVED; HOWEVER, THE TIP OF THE BALLOON HAD BECOME SHEARED OFF. THE 5FR SHEATH WAS REMOVED AND WAS REPLACED WITH A 6FR 45CM SHEATH OVER TWO GUIDEWIRES. THE OLD SHEATH WAS FLUSHED AND THERE WAS NO EVIDENCE OF BALLOON MATERIAL WITHIN THE SHEATH. SCREENING AT THE LEVEL OF THE AT SHOWED THE BALLOON TIP WAS ON THE GUIDEWIRE. THE WIRE WAS SNARED BELOW THE LEVEL OF THE BALLOON TIP AFTER BRINGING ANOTHER GUIDEWIRE BELOW IT WITHIN THE AT. THE GUIDEWIRE SNARED SUCCESSFULLY, AND THE BALLOON TIP WAS SUCCESSFULLY REMOVED. ANGIOGRAPHY WAS

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17623629 ↗

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Sources and updates

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