Sprinter™ SPR1512WRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169850330), received between Jul 9, 2019 and Nov 1, 2019 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Burst Container or Vessel” (2 reports).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryNov 1, 2019Burst Container or Vessel; Burst Container or Vessel

  DURING A PTCA PROCEDURE AN ATTEMPT WAS MADE TO USE A SPRINTER OTW PTCA BALLOON CATHETER TO PRE-DILATE THE LEFT OBTUSE MARGINAL. THE LEFT CORONARY SYSTEM WAS NOTED TO BE HEAVILY CALCIFIED. THE SPRINTER BALLOON WAS ADVANCED OVER A 0.14 CORONARY WIRE. IT WAS REPORTED THAT WHEN AN ATTEMPT WAS MADE TO PRE-DILATE THE FIRST OBTUSE MARGINAL A BALLOON RUPTURE AND FRAGMENTATION OCCURRED. MULTIPLE ATTEMPTS WERE UNSUCCESSFUL IN FREEING THE RETAINED PORTION OF THE TRAPPED BALLOON. THE FRAGMENT WAS THEN STENTED AGAINST THE VESSEL WALL. THE VESSEL WAS THEN RE-VASCULARIZED. THE PATIENT WAS REPORTED TO BE DOING WELL POST PROCEDURE.

  Patient problems: Device Embedded In Tissue or Plaque; Injury

  MAUDE report 9265602 ↗
• MalfunctionJul 9, 2019Burst Container or Vessel; Burst Container or Vessel

  DURING A PROCEDURE IT WAS INTENDED TO USE A 1.5X12 MM SPRINTER OTW PTCA BALLOON CATHETER TO ANGIOPLASTY A LESION LOCATED IN THE FIRST OBTUSE MARGINAL. IT WAS REPORTED THAT ON INFLATION TO 6 ATM A BALLOON RUPTURE OCCURRED. NP PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8770503 ↗