SPRINTER® LEGEND SPL22512XRecalls & reported problems
Medtronic, Inc. · BLN SPL22512X SPR LEG 2.25X12 RX US M · Class 2
All models of SPRINTER LEGEND (19)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00613994902801), received between Jan 18, 2022 and Jan 18, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Difficult to Remove” (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
- Difficult to Remove1
- Material Deformation1
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.
MalfunctionJan 18, 2022Difficult to Remove; Material Deformation; Difficult to Remove; Material Deformation
ONE RESOLUTE ONYX CORONARY DRUG ELUTING STENT AND ONE SPRINTER LEGEND BALLOON CATHETER WERE ATTEMPTED TO BE USED TO TREAT A MODERATELY CALCIFIED, MODERATELY TORTUOUS LESION WITH 75% STENOSIS IN THE MID RIGHT CORONARY ARTERY (RCA). THE DEVICES WERE INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED. THE LESION WAS NOT PRE-DILATED. THE DEVICES DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE RESOLUTE ONYX BUT EXCESSIVE FORCE WAS NOT USED. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE SPRINTER LEGEND AND EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING DELIVERY TO THE LESION. THE DISLODGED STENT WAS NOT REMOVED, IT WAS CRUSHED AGAINST THE VESSEL WALL. IT WAS ALSO REPORTED THAT REMOVAL DIFFICULTIES OCCURRED WITH THE SPRINTER LEGEND DEVICE FOLLOWING BALLOON INFLATION. THERE WAS AN ISSUE REMOVING THE BALLOON FROM THE CATHETER AS IT WAS TIGHT. THE PHYSICIAN INDICATED THAT THE CO-PILOT CLAMPED DOWN ON THE SPRINTER LEGEND AND STRETCHED THE CATHETER. NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13277994 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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