Sprinter™ SPR2012WRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169850385), received between Feb 7, 2022 and Feb 21, 2024 — classified as 3 malfunctions.

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

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 21, 2024Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  AN ATTEMPT WAS MADE TO USE ONE SPRINTER OTW BALLOON CATHETER TO TREAT A SEVERELY TORTUOUS, SEVERELY CALCIFIED LESION WITH 90% STENOSIS IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. 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. IT WAS REPORTED THAT REMOVAL DIFFICULTIES WERE ENCOUNTERED WHEN ATTEMPTING TO REMOVE THE BALLOON FOLLOWING BALLOON INFLATION. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18747462 ↗
• MalfunctionMar 21, 2022Use of Device Problem; Use of Device Problem

  ONE SPRINTER OTW BALLOON CATHETER WAS USED. THERE WAS NO DAMAGE NOTED TO THE DEVICE PACKAGING. THE DEVICE WAS REMOVED FROM THE HOOP WITH NO ISSUES NOTED. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE, EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THAT THE DEVICE WAS EXPIRED WHEN IT WAS USED IN THE PATIENT. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13838862 ↗
• MalfunctionFeb 7, 2022Material Deformation; Material Deformation

  ONE COUGAR GUIDEWIRE (PLI10) AND ONE SPRINTER OTW BALLOON (PLI20) WERE ATTEMPTED TO BE USED DURING A PROCEDURE TO TREAT A MILDLY CALCIFIED LESION IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA). THERE WERE NO ISSUES NOTED TO THE DEVICE PACKAGING. THE DEVICES WERE REMOVED FROM THE PACKAGING PER IFU, WITH NO ISSUES NOTED. THE DEVICES WERE INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. THERE WERE NO DIFFICULTIES NOTED WHEN REMOVING THE PROTECTIVE SHEATH OR THE PACKAGING STYLETTE FROM THE SPRINTER BALLOON. THE DEVICES WERE PREPPED PER IFU WITH NO ISSUES NOTED. THE COUGAR GUIDEWIRE AND THE GUIDEWIRE LUMEN IN THE SPRINTER BALLOON WERE FLUSHED BEFORE USE. THE LESION WAS PRE-DILATED. THE DEVICES DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICES BUT EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THAT DIFFICULTIES WERE NOTED WHEN LOADING THE BALLOON ONTO THE GUIDEWIRE. IT WAS STATED THAT THE BALLOON SEEMED TO GET STUCK ON THE WIRE. THE EVENT OCCURRED WHILE ATTEMPTING TO DELIVER THE SPRINTER BALLOON TO THE LESION SITE. THE SPRINTER BALLOON DID EXIT THE TIP OF THE GUIDE CATHETER. THE GUIDEWIRE WAS FRONT LOADED THROUGH THE WIRE ENTRY PORT. THE GUID

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13471857 ↗