SprinterRecalls & reported problems across all models

We found 6 models of Sprinter by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 11 adverse event reports in the FDA's MAUDE database, received between May 30, 2017 and Jul 28, 2025 — classified as 4 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (7 reports).

1 FDA recall record name at least one of these models by its device identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Sprinter recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Jun 24, 2022Open, Classified

   Luer has balloon diameter printed as "2.25mmx12mm" instead of the correct diameter, "2.5mmx12mm" as reflected on the product outer packaging.

   Z-1483-2022 · Root cause: Labeling Change Control · Recall details · FDA record ↗

Most reported Sprinter problems

Sprinter models

6 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Sprinter™ SPR2512W

  Catheters, transluminal coronary angioplasty, percutaneous
  1 recall1 report
• Sprinter™ SPR2012W

  Catheters, transluminal coronary angioplasty, percutaneous
  3 reports
• SPRINTER® SPR1512W

  Catheters, transluminal coronary angioplasty, percutaneous
  3 reports
• Sprinter™ SPR1512W

  Catheters, transluminal coronary angioplasty, percutaneous
  2 reports
• Sprinter™ SPR1510W

  Catheters, transluminal coronary angioplasty, percutaneous
  1 report
• SPRINTER® SPR1515W

  Catheters, transluminal coronary angioplasty, percutaneous
  1 report

Recent Sprinter adverse event reports

The 11 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryJul 28, 2025Burst Container or Vessel; Difficult to Remove; Detachment of Device or Device Component; Burst Container or Vessel; Difficult to Remove; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING ONE SPRINTER BALLOON CATHETER, THE BALLOON RUPTURED AND THEN BECAME STUCK IN THE VESSEL. REMOVAL DIFFICULTIES WERE ENCOUNTERED FOLLOWING BALLOON INFLATION. THE DEVICE DETACHED AT THE BALLOON DURING REMOVAL. A NON-MEDTRONIC GUIDEWIRE AND NON-MEDTRONIC MICRO CATHETER WERE USED IN AN ATTEMPT TO SNARE THE BALLOON HOWEVER WHEN THE PHYSICIAN PROCEEDED TO TAKE OUT THE GUIDEWIRE, THE BALLOON DISLODGED FURTHER INTO THE VESSEL AND WAS UNABLE TO BE RETRIEVED. THE LESION BEING TREATED WAS MODERATELY TORTUOUS AND SEVERELY CALCIFIED LOCATED IN THE MID RAMUS WITH 95% STENOSIS. THE DEVICE WAS USED TO PRE-DILATE THE LESION. THE DEVICE WAS NOT MOVED OR RE-POSITIONED WHILE INFLATED. THE DEVICE WAS INSPECTED PRIOR TO USE AND NEGATIVELY PREPPED WITH NO ISSUES. 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 DURING DELIVERY. A PROPER AMOUNT OF FORCE TO WITHDRAW THE DEVICE. THE DEVICE WAS NOT KINKED AND RE-STRAIGHTENED DURING USE. THE PATIENT'S PRESSURE BECAME ELEVATED DUE TO OCCLUSION/DISRUPTING IN THE ARTERY. THE PATIENT SUSTAINE

  Patient problems: Device Embedded In Tissue or Plaque; Insufficient Information; Myocardial Infarction; Obstruction/Occlusion

  MAUDE report 22629079 ↗
• 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 ↗
• MalfunctionJun 8, 2022Device Markings/Labelling Problem; Device Markings/Labelling Problem

  AN ATTEMPT WAS MADE TO USE A SPRINTER OTW PTCA BALLOON CATHETER IN A SEVERELY CALCIFIED LESION IN THE RIGHT SUPERFICIAL FEMORAL ARTERY AND THE RIGHT COMMON FEMORAL ARTERY (SFA/CFA) WITH 100% STENOSIS FOR SFA AND 85% STENOSIS FOR CFA. THERE WAS NO DAMAGE NOTED TO THE PACKAGING. THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS INSPECTED WITH ISSUES. 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 SPRINTER OTW DEVICE WAS BACK LOADED WITH A 0.014¿ WIRE WITHOUT ANY ISSUES. WHEN THE WIRE WAS EXCHANGED, IT CAME OUT OK HOWEVER THE NEXT WIRE USED WOULD NOT ADVANCE. THE BALLOON CATHETER HAD TO BE CUT TO REMOVE THE GUIDEWIRE. AFTER THE PROCEDURE THE PRODUCT WAS REVIEWED TO DETERMINE WHY THE WIRE WOULD NOT PASS THROUGH AND FOUND THAT THE BALLOON WAS A 2.25 X12MM, THE PACKAGING DETAILED A 2.5 X X12MM DEVICE. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14632446 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• InjuryOct 19, 2017Burst Container or Vessel; Detachment of Device or Device Component; Burst Container or Vessel; Detachment of Device or Device Component

  IT WAS INTENDED TO USE A SPRINTER OTW BALLOON CATHETER TO TREAT A SEVERELY TORTUOUS, SEVERELY CALCIFIED DISTAL LESION EXHIBITING 95% STENOSIS IN A PERIPHERAL ARTERY (BELOW THE KNEE NEAR THE FOOT). THERE WAS NO DAMAGE NOTED TO PACKAGING OR ISSUES REMOVING THE DEVICE FROM THE HOOP/TRAY. NO STYLET REMOVAL DIFFICULTIES. THE DEVICE WAS INSPECTED AND PREPPED WITH NO ISSUES NOTED. THE LESION WAS NOT PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE HOWEVER EXCESSIVE FORCE WAS NOT USED. THE DEVICE WAS NOT KINKED AND RE-STRAIGHTENED DURING USE. IT IS REPORTED THAT UPON INFLATION, THE BALLOON BURST AT 10 ATM. THERE WAS A SUDDEN DROP IN PRESSURE FROM INFLATION DEVICE. THE BALLOON WAS NOT REPOSITIONED BEFORE BURST. THE BALLOON THEN SEPARATED FROM THE SHAFT WITH THE SINGLE MARKER INTACT AND WHEN THE PHYSICIAN REMOVED THE SYSTEM FROM THE PATIENT THE DETACHED PORTION REMAINED IN THE VERY DISTAL TIBIAL ARTERY. AN ATTEMPT WAS MADE TO SNARE WITH A LOOP SNARE HOWEVER THE SNARE COULD NOT GET ALL THE WAY DOWN TO THE FOOT. A SURGICAL CONSULT DECIDED THAT IT WAS NOT AN OPTION TO CUT DOWN AND REMOVE THE BALLOON. THE DETACHED PORT

  Patient problems: Device Embedded In Tissue or Plaque; Patient Problem/Medical Problem

  MAUDE report 6960660 ↗
• 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 ↗

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