SPARTACORE 1005203Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 08717648014031), received between Aug 8, 2016 and May 10, 2024 — classified as 8 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (10 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjuryMay 10, 2024Difficult to Remove; Material Separation; Difficult to Remove; Material Separation

  USER FACILITY MEDWATCH REPORT RECEIVED STATES "THE SURGEON WAS USING A HI-TORQUE SPARTACORE 14 GUIDE WIRE DURING A PROCEDURE, AND IT BECAME STUCK IN PATIENT. THE END OF GUIDE WIRE BROKE OFF IN PATIENT. UNABLE TO RETRIEVE A PIECE AND MD CHOSE TO LEAVE IN THE PATIENT AS THE RISKS OF REMOVAL ATTEMPT OUTWEIGHED THE BENEFIT. NO HARM TO THE PATIENT". IN ADDITION, IT WAS NOTED THAT NO INTERVENTION WAS PERFORMED AND THE TIP REMAINED FREE FLOATING IN THE PATIENT DUE TO DIFFICULTY OF THE PROCEDURE. THE PATIENT IS NOW DECEASED; HOWEVER, IT WAS NOTED THAT THE DEATH WAS NOT RELATED TO THE DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 19289568 ↗
• InjuryOct 3, 2023Material Separation; Material Twisted/Bent; Material Separation; Material Twisted/Bent

  A USER FACILITY MEDWATCH REPORT (MW5145069) WAS RECEIVED THAT STATES: DURING ANGIOGRAM, THE SPARTACARE 14 WIRE BECAME COILED AND BROKE UPON REMOVAL. ONE PIECE ABLE TO BE RETRIEVED, THE OTHER REQUIRED STENTING TO KEEP IN PLACE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 17861003 ↗
• MalfunctionMar 24, 2023Difficult to Remove; Stretched; Difficult to Remove; Stretched

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A MODERATELY CALCIFIED LEFT POSTERIOR TIBIAL ARTERY. THE SPARTACORE GUIDE WIRE WAS USED WITHOUT ISSUE; HOWEVER, AT THE COMPLETION OF THE PROCEDURE, THE GUIDE WIRE WAS REMOVED WITH SOME RESISTANCE FELT AGAINST THE UNSPECIFIED DELIVERY CATHETER. UPON REMOVAL, IT WAS NOTED THAT THE SPARTACORE GUIDE WIRE COILS HAD STRETCHED; HOWEVER, THE DEVICE REMAINED IN ONE PIECE. THE ENTIRE DEVICE WAS REMOVED AND THERE WAS NO ADVERSE PATIENT EFFECT OR CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16614030 ↗
• InjuryOct 3, 2022Material Separation; Difficult to Advance; Material Separation; Difficult to Advance

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH COMPLETE OCCLUSION OF THE LOWER LEG AND SEPSIS. THE PROCEDURE WAS TO TREAT THE RESTENOSED LESION IN AN ARTERY BELOW THE KNEE WITH HEAVY CALCIFICATION AND MILD TORTUOSITY. THE HI-TORQUE SPARTACORE GUIDEWIRE (GW) WAS ADVANCED WITH DIFFICULTY DUE TO THE ANATOMY. THE GW WAS USED WITH AN ATHERECTOMY SYSTEM. THEN DURING DILATATION WITH AN ARMADA BALLOON IT WAS NOTED THAT A PIECE OF THE GW REMAINED IN THE PATIENT. LATER IN THE DAY, DUE TO THE SEVERE SEPSIS, THE PATIENT'S LEG WAS AMPUTATED. PER THE PHYSICIAN, THE AMPUTATION WAS NOT RELATED TO THE GW SEPARATION. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA OR A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 15533878 ↗
• InjuryJul 29, 2022Material Separation; No Apparent Adverse Event; Material Separation; No Apparent Adverse Event

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE HEAVILY CALCIFIED SUPERFICIAL FEMORAL ARTERY. THERE WAS NO DIFFICULTY NOTED ADVANCING THE GUIDE WIRE TO THE TARGET LESION OR ADVANCING / WITHDRAWING ANY DEVICES OVER THE GUIDE WIRE. THE DEVICE WAS REMOVED WITHOUT DIFFICULTY; HOWEVER, IT WAS NOTED THAT THE TIP OF THE DEVICE SEPARATED AND REMAINED IN THE PATIENT ANATOMY. THERE WAS NO ATTEMPT MADE TO REMOVE THE TIP AND THE SEPARATED SEGMENT REMAINS IN THE PATIENT ANATOMY. NO ADDITIONAL TREATMENT WAS REPORTED. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15130931 ↗
• MalfunctionJul 25, 2022Break; Peeled/Delaminated; Difficult to Remove; Break; Peeled/Delaminated; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A POPLITEAL ARTERY. DURING REMOVAL OF A SPARTACORE GUIDE WIRE, RESISTANCE WAS MET WITH AN UNSPECIFIED SOURCE AND ONCE THE GW WAS REMOVED IT WAS NOTED THAT THE TIP WAS UNRAVELED (STILL IN ONE PIECE). ADDITIONALLY IT ALSO LOOKED LIKE IT SHEARED/PEELED. INTRAVASCULAR IMAGING CONFIRMED THAT NOTHING WAS LEFT IN THE ANATOMY. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15099010 ↗
• MalfunctionJun 17, 2022Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LEFT PERONEAL ARTERY WITH RIGHT GROIN ACCESS. A SPARTACORE GUIDE WIRE WAS ADVANCED AND THE 2.0X200MM ARMADA 14 BALLOON CATHETER WAS ADVANCED. THERE WAS NO DIFFICULTY REMOVING THE STYLET OR PROTECTIVE SHEATH AND THE BALLOON WAS PREPARED/FLUSHED PRIOR TO USE. THE BALLOON WAS ATTEMPTED TO BE INFLATED BUT THERE WAS A LOT OF RESISTANCE. IT TOOK A LOT OF PRESSURE TO INFLATE THE BALLOON AND IT WAS ONLY PARTIALLY INFLATED AND NOT UNIFORMLY SHAPED. THE DEVICE WAS LOSING PRESSURE BUT THERE WAS NO LEAK OF CONTRAST NOTED IN THE VESSEL AS THE BALLOON WAS INFLATING, NOR WAS THERE ANY BLOOD BACKFILLING THE INFLATION DEVICE SO IT WAS DIFFICULT TO TELL IF THERE WAS A RUPTURE. WHEN ATTEMPTING TO REMOVE THE ARMADA BALLOON, IT BECAME STUCK WITH THE SPARTACORE GUIDE WIRE IN THE SUPERFICIAL FEMORAL ARTERY AND THEY WERE PULLED OUT TOGETHER, CAUSING WIRE ACCESS TO BE LOST. THERE WAS NO ATTEMPT MADE TO MOVE THE GUIDE WIRE WHILE THE BALLOON WAS PRESSURIZED/INFLATED. THE PHYSICIAN NOTED A THREAD OF WHAT SEEMED TO BE PLASTIC MATERIAL AT THE HUB OF THE ARMADA SHEATH AND PULLED IT OUT WITHOUT INTERVENTION. IT WAS A LONG PLASTIC MATERIAL BUT ANGIOGRAPHY POST PR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14735236 ↗
• MalfunctionMar 2, 2022Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN 80% STENOSED LESION LOCATED IN A MODERATELY CALCIFIED AND DIFFICULT ANGLED RIGHT RENAL ARTERY. A HI-TORQUE (HT) SPARTACORE GUIDE WIRE WAS PLACED IN POSITION. THE HERCULINK STENT SYSTEM HAD RESISTANCE WITH THE GUIDE WIRE DURING ADVANCEMENT BUT THE PHYSICIAN GOT IT INTO POSITION. HOWEVER, THE PHYSICIAN LOST ACCESS TO THE ARTERY AND THE GUIDE WIRE POPPED FROM THE ARTERY BUT DID NOT DAMAGE THE ARTERY. THE STENT COULDN'T BE REMOVED FROM THE GUIDE WIRE SO THE STENT AND THE GUIDE WIRE WERE PULLED AS ONE UNIT. THE PROCEDURE WAS ABORTED DUE TO THE ANATOMICAL CHALLENGES. THERE WAS NO ADVERSE PATIENT EFFECT AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13653707 ↗
• MalfunctionFeb 26, 2022Difficult to Remove; Improper or Incorrect Procedure or Method; Difficult to Remove; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE 100% OCCLUDED OSTIAL SUPERIOR MESENTERIC ARTERY (SMA). THE HERCULINK ELITE STENT DELIVERY SYSTEM WAS ADVANCED OVER A LONG SPARTACORE GUIDE WIRE. NO ISSUES WERE NOTED DURING ADVANCEMENT WITH THE GUIDE WIRE, BUT DIFFICULTY WAS NOTED ADVANCING THE HERCULINK ELITE DUE TO THE PATIENT ANATOMY, SO REMOVAL OF THE DEVICE WAS INITIATED; HOWEVER, DURING REMOVAL, RESISTANCE WAS NOTED WITH THE GUIDE WIRE. THE DEVICE WAS PULLED AND THE HERCULINK ELITE STENT DELIVERY SEPARATED AT A LOCATION OUTSIDE THE PATIENT ANATOMY. AFTER REMOVING THE PROXIMAL DEVICE, THE PROXIMAL GUIDE WIRE WAS CUT TO REMOVE THE HERCULINK ELITE SEPARATED SEGMENT. THE PROCEDURE CONTINUED USING THE SAME CUT GUIDE WIRE. A SECOND HERCULINK ELITE WAS THEN IMPLANTED WITHOUT ISSUE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13609412 ↗
• InjuryNov 26, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A TIBIAL ARTERY. TWO 190CM HI-TORQUE COMMAND EXTRA SUPPORT GUIDE WIRES (GW) WERE ADVANCED TO THEIR DESIGNATED LOCATION WITHOUT ISSUE; HOWEVER, RESISTANCE WITH THE GUIDELINERS WAS MET DURING REMOVAL, SO THEY WERE REMOVED AS A SINGLE UNIT. A 5CM HI-TORQUE SPARTACORE 14 300 GW WAS ADVANCED WITHOUT ISSUE, BUT DURING USE, THE TIP SEPARATED IN THE TIBIAL ARTERY. THE TIP WAS SUCCESSFULLY SNARED. THERE WAS NO ADVERSE PATIENT SEQUELA OR A CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10909394 ↗
• MalfunctionSep 3, 2020Break; Difficult to Insert; Stretched; Break; Difficult to Insert; Stretched

  IT WAS REPORTED THAT AFTER INSERTING INTO THE BALLOON DILATATION CATHETER (BDC) WITH RESISTANCE NOTED, THE TIP OF THE SPARTACORE GUIDE WIRE WAS SHREDDED/COILS WERE EXPOSED [POSSIBLE BREAKAGE] AND UNABLE TO BE USED. THE GUIDE WIRE WAS IMMEDIATELY REMOVED. IT WAS CONFIRMED THAT NOTHING REMAINED IN THE PATIENT. A NEW GUIDE WIRE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10490567 ↗
• InjuryDec 27, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT THIS WAS A PROCEDURE TO TREAT A LESION WITH HEAVY CALCIFICATION AND NO TORTUOSITY IN THE ILIAC ARTERY. A NON-ABBOTT BALLOON CATHETER WAS ADVANCED OVER THE SPARTA CORE GUIDE WIRE TO THE TARGET LESION WITHOUT RESISTANCE. AFTER PRE-DILATATION, THE BALLOON CATHETER WAS REMOVED, AND IT WAS NOTED THAT THE GUIDE WIRE SEPARATED 3 TO 5 CM FROM THE TIP. THE SEPARATED PORTION WAS RETRIEVED FROM THE ANATOMY VIA A SNARE DEVICE. THERE WAS NO RESISTANCE NOTED DURING REMOVAL OF THE BALLOON CATHETER. THE PROCEDURE WAS COMPLETED USING ANOTHER NEW GUIDE WIRE AND A STENT IMPLANTED SUCCESSFULLY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9526118 ↗
• MalfunctionOct 31, 2019Peeled/Delaminated; Off-Label Use; Difficult to Advance; Peeled/Delaminated; Off-Label Use; Difficult to Advance

  IT WAS REPORTED THAT OUTSIDE THE ANATOMY AN ATHERECTOMY CATHETER WAS BEING ADVANCED OVER A HI-TORQUE SPARTACORE 14 GUIDE WIRE; HOWEVER, RESISTANCE WAS FELT AND IT WAS NOTED THAT THE POLYMER COATING WAS PEELING. THE GUIDE WIRE WAS REMOVED FROM THE ATHERECTOMY CATHETER. THE ATHERECTOMY CATHETER WAS FLUSHED AND USED SUCCESSFULLY WITH A NEW HI-TORQUE SPARTACORE 14 GUIDE WIRE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 9263347 ↗
• MalfunctionApr 30, 2019Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DISTAL RENAL ARTERY. A HI-TORQUE SPARTACORE GUIDEWIRE (GW)AND A HERCULINK ELITE STENT DELIVERY SYSTEM (SDS) WERE ADVANCED WITHOUT ISSUES AND THE HERCULINK WAS IMPLANTED. HOWEVER, WHEN REMOVING THE SDS, RESISTANCE WAS FELT WITH THE GW. THE SDS WAS PULLED OUT BY HAND WITH THE GUIDE WIRE STUCK IN THE SDS, AS A SINGLE UNIT. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY DURING THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8566930 ↗
• MalfunctionApr 19, 2019Difficult to Remove; Material Separation; Difficult to Remove; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A NON-TORTUOUS AND CALCIFIED LESION IN THE RENAL ARTERY. A 6F JR4-SHAPED NON-ABBOTT GUIDE CATHETER AND SPARTACORE GUIDE WIRE WERE ADVANCED IN THE PATIENT ANATOMY WITHOUT ISSUE. A 4.0X15MM VIATRAC PLUS BALLOON DILATATION CATHETER (BDC) WAS THEN ADVANCED TO THE LESION AND INFLATED ONCE TO 8 ATMOSPHERES. THE BDC WAS FULLY DEFLATED AND ATTEMPTED TO BE REMOVED WHEN THE BDC BECAME STUCK ON THE GUIDE WIRE. FORCE WAS USED, AND THE DISTAL PORTION OF THE GUIDE WIRE SEPARATED AND A PORTION OF THE BDC BALLOON SEPARATED. DUE TO THE LONG (300CM) GUIDE WIRE, SCISSORS WERE THEN USED TO CUT OFF THE DISTAL 1/3 PORTION OF THE GUIDE WIRE FOR EASE OF HANDLING, AND BOTH THE PROXIMAL PORTION OF THE GUIDE WIRE AND THE BDC (INCLUDING THE SEPARATED BALLOON) WERE REMOVED FROM THE PATIENT ANATOMY. THE PRE-PLACED GUIDE CATHETER WAS THEN ADVANCED FORWARD IN THE PATIENT ANATOMY, AND THE SEPARATED PORTION OF THE GUIDE WIRE WAS ABLE TO BE RETRIEVED FROM WITHIN THE GUIDE CATHETER AND WAS COMPLETELY REMOVED FROM THE PATIENT ANATOMY. IT WAS CONFIRMED THAT NO PART OF THE BDC NOR GUIDE WIRE REMAINED IN THE PATIENT ANATOMY. A WHISPER ES GUIDE WIRE AND 5.0X15MM HE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8532769 ↗
• InjuryDec 6, 2018Difficult to Remove; Material Separation; Difficult to Remove; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN UNSPECIFIED ARTERY IN THE RIGHT LEG BELOW THE KNEE THAT DID NOT HAVE ANY TORTUOSITY OR CALCIFICATION. A 300 CM SPARTACORE GUIDE WIRE WAS USED; HOWEVER, THE TIP SEPARATED INSIDE THE ANATOMY DURING REMOVAL WITH A SUPPORT CATHETER. THEREFORE, A SNARE DEVICE WAS USED TO REMOVE THE COMPONENT, AND ANOTHER UNSPECIFIED SPARTACORE GUIDE WIRE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8139783 ↗
• MalfunctionSep 29, 2017Device Expiration Issue

  IT WAS REPORTED THAT A SPARTACORE GUIDE WIRE WAS USED PAST THE EXPIRATION DATE OF 4/2017. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6904218 ↗
• InjuryAug 8, 2016Detachment Of Device Component; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A CHRONIC TOTAL OCCLUSION IN THE MID SUPERFICIAL FEMORAL ARTERY WITH HEAVY CALCIFICATION AND MILD TORTUOSITY. A HIGH TORQUE (HT) SPARTACORE GUIDE WIRE WAS ADVANCED TOWARD THE TARGET LESION. A NON-ABBOTT RE-ENTRY CATHETER WAS ADVANCED OVER THE GUIDE WIRE. WHEN THE RE-ENTRY CATHETER WAS PULLED RESISTANCE WAS NOTED AND THE NEEDLE ON THE DEVICE BROKE THE GUIDE WIRE TIP OFF WHICH REMAINED IN SUBINTIMAL SPACE. NO ATTEMPT WAS MADE TO RETRIEVE THE SEPARATED TIP. EVERYTHING WAS PULLED OUT AND A NEW ALL STAR GUIDE WIRE WAS ADVANCED TOWARD THE TARGET LESION. A NEW RE-ENTRY CATHETER WAS SUCCESSFULLY ADVANCED OVER THE GUIDE WIRE TO TREAT THE LESION. THE LESION WAS ULTIMATELY TREATED WITH TWO SUPERA STENTS. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 5855302 ↗