Sprinter™ SPR1510WRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169850323), received between Jul 28, 2025 and Jul 28, 2025 — classified as 1 injury.

The most frequently reported specific device problem is “Burst Container or Vessel” (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

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJul 28, 2025Burst Container or Vessel; Difficult to Remove; Detachment of Device or Device Component; Burst Container or Vessel; Difficult to Remove; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING ONE SPRINTER BALLOON CATHETER, THE BALLOON RUPTURED AND THEN BECAME STUCK IN THE VESSEL. REMOVAL DIFFICULTIES WERE ENCOUNTERED FOLLOWING BALLOON INFLATION. THE DEVICE DETACHED AT THE BALLOON DURING REMOVAL. A NON-MEDTRONIC GUIDEWIRE AND NON-MEDTRONIC MICRO CATHETER WERE USED IN AN ATTEMPT TO SNARE THE BALLOON HOWEVER WHEN THE PHYSICIAN PROCEEDED TO TAKE OUT THE GUIDEWIRE, THE BALLOON DISLODGED FURTHER INTO THE VESSEL AND WAS UNABLE TO BE RETRIEVED. THE LESION BEING TREATED WAS MODERATELY TORTUOUS AND SEVERELY CALCIFIED LOCATED IN THE MID RAMUS WITH 95% STENOSIS. THE DEVICE WAS USED TO PRE-DILATE THE LESION. THE DEVICE WAS NOT MOVED OR RE-POSITIONED WHILE INFLATED. THE DEVICE WAS INSPECTED PRIOR TO USE AND NEGATIVELY PREPPED WITH NO ISSUES. THE LESION WAS PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. A PROPER AMOUNT OF FORCE TO WITHDRAW THE DEVICE. THE DEVICE WAS NOT KINKED AND RE-STRAIGHTENED DURING USE. THE PATIENT'S PRESSURE BECAME ELEVATED DUE TO OCCLUSION/DISRUPTING IN THE ARTERY. THE PATIENT SUSTAINE

  Patient problems: Device Embedded In Tissue or Plaque; Insufficient Information; Myocardial Infarction; Obstruction/Occlusion

  MAUDE report 22629079 ↗