SPRINTER® LEGEND SPL12515XRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169271777), received between Jul 11, 2019 and Mar 26, 2025 — classified as 1 injury, 2 malfunctions.

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

• InjuryMar 26, 2025Difficult to Remove; Improper or Incorrect Procedure or Method; Detachment of Device or Device Component; Difficult to Remove; Improper or Incorrect Procedure or Method; Detachment of Device or Device Component

  IT WAS REPORTED THAT ONE SPRINTER LEGEND BALLOON CATHETER DETACHED DURING REMOVAL OF THE DEVICE FROM THE PATIENT. THE LESION BEING TREATED WAS MODERATELY TORTUOUS, MODERATELY CALCIFIED WITH 90% STENOSIS IN THE MID LEFT MAIN (LM) CORONARY ARTERY AND OBTUSE MARGINAL (OM). THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ISSUES. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE DEVICE WAS BEING USED TO PRE-DILATE THE LESION AND 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. THE DEVICE WAS INSERTED INTO THE MID CIRCUMFLEX CORONARY IN PREPARATION FOR STENT PLACEMENT. WHEN PLACING THE BALLOON, SOME MANEUVERABILITY WAS REQUIRED BUT NOTHING THAT WOULD BE UNEXPECTED. THE BALLOON WAS INFLATED TO 20 ATM FOR 30 SECONDS. AFTER INFLATION AN ATTEMPT WAS MADE TO WITHDRAW THE BALLOON AT WHICH TIME THE BALLOON DISCONNECTED FROM THE WIRE BREAKING FREE. MULTIPLE ATTEMPTS WERE MADE TO RETRIEVE THE BALLOON WITHOUT SUCCESS. BALLOONS AND WIRES WERE INSERTED TO TRY AND REMOVE THE DETACHED DEVICE AND GET IT TO A PLACE WHERE IT COULD BE SNARED. HOWEVER, THE DETACHED BALLOON REMAINS IN THE

  Patient problems: Device Embedded In Tissue or Plaque; Insufficient Information; Myocardial Infarction; Non specific EKG/ECG Changes; Obstruction/Occlusion

  MAUDE report 21695681 ↗
• MalfunctionJan 4, 2021Fracture; Fracture

  DURING A PROCEDURE, AN ATTEMPT WAS MADE TO USE ONE SPRINTER LEGEND RX PTCA BALLOON CATHETER TO TREAT A LESION LOCATED IN THE RIGHT CORONARY ARTERY. THERE WAS NO DAMAGE NOTED TO THE PACKAGING AND THERE WAS NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. AN ATTEMPT WAS MADE TO CONNECT THE LUER OF THE SPRINTER LEGEND TO AN INFLATION DEVICE WITH NO ISSUES NOTED. THE LUER OF THE SPRINTER LEGEND WAS NOT INSPECTED PRIOR TO ATTACHING TO THE INFLATION DEVICE. THE SPRINTER LEGEND WAS CONNECTED DIRECTLY TO THE INFLATION DEVICE. NEGATIVE PREP WAS PERFORMED WITH THE FIRST SPRINTER LEGEND BALLOON WITH NO ISSUES NOTED. THE LESION WAS NOT 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 DURING DELIVERY. IT WAS REPORTED THAT THE DEVICE FRACTURED/CRACKED AT THE LUER/HUB. THE CRACK WAS NOT NOTED PRIOR TO ATTACHING THE LUER OF THE SPRINTER LEGEND TO THE INFLATION DEVICE. IT WAS STATED THAT WHEN ATTEMPTING TO INFLATE, THE CONTRAST SPRAYED OUT OF THE HUB. THE DEVICE WAS NOT KINKED AND RESTRAIGHTENED DURING USE. THE PATIENT WAS REPORTED TO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11106901 ↗
• MalfunctionJul 11, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  DURING THE PROCEDURE AN ATTEMPT WAS MADE TO USE A SPRINTER LEGEND RX PTCA BALLOON CATHETER TO TREAT A HEAVILY CALCIFIED LESION IN THE LAD. THERE WAS NO DAMAGE NOTED TO THE PACKAGING OR ANY ISSUES NOTED WHEN REMOVING FROM THE HOOP. THE GUIDE WIRE WAS EXAMINED AND FLUSHED BEFORE USE WITH NO ISSUES NOTED. THE SPRINTER LEGEND BALLOON WAS INSPECTED PRIOR TO USE. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. ON FIRST INFLATION, THE BALLOON WAS INFLATED TO 14 ATM AND GOT STUCK ON THE 0.014"X300 CM NON-MEDTRONIC GUIDEWIRE. IT WAS REPORTED THAT THE DEVICE WAS UNABLE TO BE REMOVED FROM THE GUIDE WIRE. THE SPRINTER LEGEND AND THE GUIDEWIRE WERE REMOVED TOGETHER FROM THE PATIENT. IT WAS INFORMED THAT THE BALLOON CAME OFF THE WIRE. NO PATIENT INJURY WAS REPORTED. ANALYSIS OF THE RETURNED DEVICE REVEALED THE INNER MEMBER, BALLOON AND TIP HAD DETACHED FROM THE DELIVERY SYSTEM AND WERE ENTRAPPED ON THE GUIDE WIRE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8779978 ↗