SPRINTER® SPR1512WRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885074197012), received between May 30, 2017 and Feb 22, 2018 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 22, 2018Burst Container or Vessel; Burst Container or Vessel

  PATIENT HAD HISTORY OF CORONARY HEART DISEASE. A SPRINTER OTW BALLOON CATHETER WAS USED TO TREAT A HEAVILY CALCIFIED RCA LESION. THE LESION HAD BEEN PREVIOUSLY STENTED. A EUPHORA BALLOON CATHETER WAS ALSO USED. IT WAS REPORTED THAT HE BALLOONS WERE INFLATED TO NOMINAL AND RATED PRESSURES WHEN THE BALLOONS RUPTURED DUE TO SHARP CALCIUM AND/OR STENT STRUTS WHICH MOST LIKELY IMPALED THE BALLOONS AT THE RIGHT RATED ATMS. MULTIPLE BALLOONS WERE USED AND BROKE DURING USE. EVERYTHING WAS REMOVED FROM THE BODY. THERE WERE NO BAD PATIENT OUTCOMES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7288211 ↗
• InjuryJan 26, 2018Burst Container or Vessel; Burst Container or Vessel

  THE PHYSICIAN ATTEMPTED TO USE A SPRINTER OTW BALLOON CATHETER TO TREAT A HEAVILY CALCIFIED LESION IN THE RCA. THE BALLOON WAS FLUSHED AND PREPPED PRIOR TO USE. RESISTANCE WAS NOTED WHEN ADVANCING THE DEVICE DUE TO PREVIOUS ISR AND HEAVY CALCIFICATION. THE BALLOON WAS INSERTED INTO THE VESSEL. ON THE THIRD INFLATION OF 14 ATM FOR 6 SECONDS (1520PM), THE BALLOON BURST. THE BALLOON RUPTURE OCCURRED AT NOMINAL PRESSURE. THE BALLOON WAS REMOVED FROM THE PATIENT AND EXAMINED TO ENSURE ALL MATERIAL WAS ACCOUNTED FOR AND NONE WAS LEFT IN THE VESSEL. SUBSEQUENT BALLOON SIZES WERE USED TO OPEN THE ISR. THE PROCEDURE WAS COMPLETED WITH A STENT IN STENT. NO ADVERSE PATIENT EFFECT OCCURRED AND THE PATIENT IS REPORTED TO BE GOOD. A EUPHORA BALLOON WAS ALSO USED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7221016 ↗
• MalfunctionMay 30, 2017Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT THE PHYSICIAN WAS ATTEMPTING TO USE A SPRINTER OVER THE WIRE BALLOON CATHETER TO TREAT A SEVERELY CALCIFIED VESSEL. IT WAS REPORTED THAT THE BALLOON RUPTURED WHEN INFLATED. THE BALLOON WAS REMOVED INTACT FOLLOWING RUPTURE. NO ADVERSE OUTCOME TO PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6597249 ↗