HI-TORQUE STEELCORERecalls & reported problems across all models

We found 5 models of HI-TORQUE STEELCORE by Abbott Vascular Inc. in the FDA's device registry (GUDID). Together they are named in 50 adverse event reports in the FDA's MAUDE database, received between Mar 8, 2017 and Aug 31, 2026 — classified as 1 death, 11 injuries, 38 malfunctions.

The most frequently reported specific device problem is “Break” (20 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. 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

Most reported HI-TORQUE STEELCORE problems

HI-TORQUE STEELCORE models

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

• HI-TORQUE STEELCORE 1003282

  WIRE, GUIDE, CATHETER
  1 death36 reports
• HI-TORQUE STEELCORE 1007710

  WIRE, GUIDE, CATHETER
  9 reports
• HI-TORQUE STEELCORE 1003281

  WIRE, GUIDE, CATHETER
  2 reports
• HI-TORQUE STEELCORE 1007710-J

  WIRE, GUIDE, CATHETER
  2 reports
• HI-TORQUE STEELCORE 1007709

  WIRE, GUIDE, CATHETER
  1 report

Recent HI-TORQUE STEELCORE adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionAug 31, 2026Break; Stretched

  It was reported that upon removing the Steelcore guide wire from the packaging, the tip was noted to be unraveled "[broken]". Therefore there was no device use or patient involvement. Another device was used to complete the procedure. No additional information was provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50525252 ↗
• InjuryAug 31, 2026Entrapment of Device

  It was reported that this was a CardioMEMS sensor implant procedure. The Steelcore guide wire was advanced through the left pulmonary artery and the CardioMEMS sensor was deployed. The delivery system was attempted to be removed; however it was noted that the Steelcore guide wire was engaging with the distal loop of the sensor and moving it. The Swan Ganz catheter used previously in the procedure was advanced with a balloon to try to retract the wire while blocking the sensor from moving backwards; however this was unsuccessful. A glide catheter was then inserted to disengage and retract the wire. This was successful and the patient remained stable with no complications. No additional information was provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50524880 ↗
• MalfunctionJul 8, 2026Difficult to Remove

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25750835 ↗
• MalfunctionJun 5, 2026Difficult to Remove

  IT WAS REPORTED THE PROCEDURE WAS TO IMPLANT A CARDIOMEMS SENSOR. THE STEELCORE GUIDE WIRE WAS ADVANCED INTO THE PATIENT FOLLOWED BY THE CARDIOMEMS DELIVERY CATHETER OVER THE WIRE. PRIOR TO DEPLOYMENT OF THE SENSOR, AN ATTEMPT WAS MADE TO RETRACT THE GUIDEWIRE INTO THE DELIVERY SYSTEM HOWEVER IT WAS NOTED THE WIRE WOULD NOT RETRACT. AFTER MANIPULATION, THE WIRE WAS ABLE TO BE COMPLETELY REMOVED AND A NEW STEELCORE WIRE WAS ADVANCED. THE SAME ISSUE THEN OCCURRED WITH THE SECOND WIRE, WITH RESISTANCE ENCOUNTERED WHEN ATTEMPTING TO RETRACT THE WIRE BACK INTO THE DELIVERY SYSTEM. AT THAT POINT, THE PHYSICIAN¿S BECAME CONCERNED THERE MAY BE AN ISSUE WITH THE DELIVERY SYSTEM ITSELF; THEREFORE THE DECISION WAS MADE TO REMOVE THE ENTIRE SYSTEM, INCLUDING THE WIRE THAT REMAINED STUCK WITHIN THE DELIVERY SYSTEM. INCREASED RESISTANCE WAS ENCOUNTERED AT THE SHEATH SITE DURING REMOVAL. AFTER ADDITIONAL MANIPULATION, THE DELIVERY SYSTEM WAS SUCCESSFULLY REMOVED THROUGH THE SHEATH WITH THE GUIDEWIRE STILL STUCK AT THE DISTAL TIP. THE SENSOR APPEARED COMPROMISED, SO A NEW DELIVERY SYSTEM WAS OPEN AND UTILIZED. NO ISSUES WERE ENCOUNTERED WITH THE SECOND DELIVERY SYSTEM OR NEW GUIDE WIRE. THE SECOND

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25410365 ↗
• MalfunctionJan 30, 2026Break

  IT WAS REPORTED THAT WHEN THE STEELCORE GUIDE WIRE WAS REMOVED FROM THE PACKAGING THE TIP WAS UNRAVELED. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24222601 ↗
• InjuryJan 27, 2026Entrapment of Device

  IT WAS REPORTED THAT THIS WAS A CARDIOMEMS SENSOR IMPLANT PROCEDURE. THE STEELCORE GUIDE WIRE WAS USED IN THE PROCEDURE. AFTER THE SENSOR WAS DEPLOYED AND UPON REMOVAL OF THE DELIVERY CATHETER IT WAS NOTED THAT THE GUIDE WIRE WAS PULLED PROXIMAL INTO THE DELIVERY CATHETER. THE CARDIOMEMS SENSOR WAS MOVING WITH THE WIRE. THE DELIVERY CATHETER WAS REMOVED COMPLETELY, AND A SWAN GANZ CATHETER WAS INSERTED OVER THE GUIDEWIRE IN ORDER TO REMOVE THE STEELCORE WIRE. AN UNSPECIFIED BALLOON WAS INFLATED TO HOLD THE SENSOR IN PLACE AS THE GUIDEWIRE WAS REMOVED. ONCE THE GUIDEWIRE WAS REMOVED THE SWAN GANZ CATHETER WAS USED TO CALIBRATE THE CARDIOMEMS SENSOR AND THE CASE WAS COMPLETED SUCCESSFULLY. THERE WERE NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24192842 ↗
• MalfunctionNov 19, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT A CARDIOMEMS HEART FAILURE (HF) SYSTEM WAS DEPLOYED OVER AN UNSPECIFIED HI-TORQUE (HT) STEELCORE 18 GUIDE WIRE IN THE LEFT PULMONARY ARTERY (PA). UPON REMOVAL OF THE HT STEELCORE GUIDE WIRE, THE CARDIOMEMS HF SYSTEM GOT CAUGHT AND WAS PULLED INTO THE PULMONARY ARCH. THE HT STEELCORE GUIDE WIRE WAS ABLE TO BE REMOVED INDEPENDENTLY. A NON-ABBOTT PA CATHETER WAS USED TO RE-ADVANCE [REPOSITION] THE CARDIOMEMS HF SYSTEM. THE CARDIOMEMS WAS PUSHED INTO THE RIGHT PA ; NOT THE DESIRED IMPLANT SITE, WHERE CALIBRATION WAS PERFORMED SUCCESSFULLY. 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 23599988 ↗
• MalfunctionOct 22, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS TO IMPLANT A CARDIOMEMS SENSOR IN THE LEFT PULMONARY ARTERY. DURING RETRACTION OF THE CARDIOMEMS DELIVERY SYSTEM THE SENSOR INTERACTED WITH THE DELIVERY SYSTEM AND / OR STEELCORE GUIDEWIRE CAUSING THE SENSOR TO BE PULLED BACK INTO THE PROXIMAL LEFT PULMONARY ARTERY. THE STEELCORE GUIDEWIRE WAS REPOSITIONED, AND THE DELIVERY SYSTEM WAS BACKED OUT OVER THE WIRE. FOLLOWING THIS THE INTERACTION WITH THE SENSOR RESOLVED ALLOWING THE SENSOR TO SETTLE IN AN ACCEPTABLE LOCATION IN THE LEFT PULMONARY ARTERY. 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 23356447 ↗
• MalfunctionAug 21, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT DURING THE PROCEDURE TO TREAT THE LEFT PULMONARY ARTERY. A RIGHT HEART CATHETER WAS INSERTED FLOOWED BY A PULMONARY ANGIOGRAM. A .018 STEELCORE GUIDE WIRE WAS PLACED IN THE ARTERY AND THE CATHETER REMOVED. THE CARDIOMEMS DELIVERY CATHETER WAS ADVANCED AND DEPLOYED. THE CATHETER WAS RE-INSERTED AND WHEN ATTEMPTING TO REMOVE THE GUIDE WIRE, THE SENSOR MIGRATED PROXIMAL. THE GUIDE WIRE AND CATHETER WERE USED TO MOVE THE SENSOR FORWARD TO A STABLE LOCATION WHERE IT REMAINED. THERE WAS 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 22865012 ↗
• MalfunctionAug 20, 2025Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT A CARDIOMEMS HEART FAILURE (HF) SYSTEM WAS USED TOGETHER WITH AN UNSPECIFIED 0.018" STEELCORE GUIDE WIRE. THE STEELCORE GUIDE WIRE WAS INSERTED THROUGH A PREPARED UNSPECIFIED PULMONARY ARTERY (PA) WEDGE-PRESSURE CATHETER, TO THE VESSEL. THE PA WEDGE CATHETER WAS REMOVED AND A CARDIOMEMS HF SYSTEM WAS ADVANCED OVER THE STEELCORE GUIDE WIRE. AS THE CATHETER WAS ADVANCING FROM THE RIGHT VENTRICLE (RV) TO THE PA, THE STEELCORE GUIDE WIRE GOT CAUGHT/PINNED DUE TO PATIENT ANATOMY. AN ATTEMPT TO REMOVE THE SENSOR WAS UNSUCCESSFUL AND THE GUIDE WIRE WAS ADVANCED TO THE PA TO THE SELECTED VESSEL BUT FAILED TO CROSS DUE TO ANATOMY. AN UNSPECIFIED 0.014" GUIDE WIRE WAS USED WITH THE PA WEDGE CATHETER TO HELP WITH TRACKING. THE UNSPECIFIED 0.014" GUIDE WIRE WAS REMOVED AND A PA WEDGE CATHETER WAS ADVANCED OVER THE REINSERTED STEELCORE GUIDE WIRE. THE CARDIOMEMS WAS DEPLOYED WITHOUT INCIDENT. THE DELIVERY CATHETER AND GUIDE WIRE WERE REMOVED WITH THE HELP OF THE BALLOON OF THE WEDGE CATHETER. 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 22854200 ↗
• MalfunctionJul 17, 2025Break; Stretched; Break; Stretched

  SUBSEQUENTLY AFTER THE INITIAL REPORT HAD ALREADY BEEN FILED, THE TIP COILS OF THE SECOND HT STEELCORE GUIDE WIRE WERE NOTED TO BE STRETCHED WITH THE CORE INTACT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22532895 ↗
• MalfunctionJul 17, 2025Break; Stretched; Break; Stretched

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A LEFT SUPERFICIAL FEMORAL ARTERY. DURING PREPARATION AND UPON OPENING THE PACKAGE OF A 300CM HI-TORQUE (HT) STEELCORE GUIDEWIRE, IT WAS NOTED THAT THE TIP OF THE GUIDEWIRE WAS UNRAVELED AND HELD TOGETHER BY THE TIP COILS AND IN ONE PIECE. THE GUIDEWIRE WAS NOT USED IN THE PATIENT AND DISCARDED. A SECOND HT STEELCORE GUIDEWIRE OF THE SAME LOT WAS USED, AND DURING THE PROCEDURE VIA ANGIOGRAPHY, THE TIP WAS OBSERVED TO ALSO BE UNRAVELED AND HELD TOGETHER BY THE TIP COILS. THE PROCEDURE WAS ABLE TO BE COMPLETED AND THE SECOND HT STEELCORE GUIDEWIRE WAS REMOVED IN ONE PIECE. IN ADDITION TO THE USED HT STEELCORE GUIDEWIRE, THE REMAINING UNOPENED HT STEELCORE GUIDEWIRES OF THE SAME LOT WILL BE RETURNING. 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 22532888 ↗
• MalfunctionJul 9, 2025Break; Stretched; Break; Stretched

  SUBSEQUENT TO THE PREVIOUSLY FILED REPORT, RETURNED DEVICE ANALYSIS FOUND THAT THE COILS WERE STRETCHED RATHER THAN A SEPARATED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22460159 ↗
• InjuryJun 10, 2025Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT TO THE PULMONARY ARTERY. A .018 NON-ABBOTT GUIDE WIRE WAS ADVANCED TO THE TARGET SITE AND THE DELIVERY SYSTEM FOR THE CARDIOMEMS DEVICE WAS ATTEMPTED BE ADVANCED OVER THE GUIDE WIRE THROUGH THE 6FR SHEATH; HOWEVER, WIRE POSITION WAS LOST AND ALL DEVICES WERE REMOVED. THEREFORE, A 7FR SHEATH AND A .018 STEELCORE GUIDE WIRE WAS POSITIONED; HOWEVER, WHEN ATTEMPTING TO ADVANCE THE DELIVERY CATHETER AGAIN GUIDE WIRE POSITION WAS LOST AND PATIENT BEGAN TO COUGH UP BLOOD. THE PROCEDURE WAS ABORTED AND THE CARDIOMEMS DEVICE WAS NOT IMPLANTED. REPEATED ANGIOGRAPHY DID NOT INDICATE VESSEL PERFORATION. THE REMAINS STABLE AND WAS ADMITTED OVER NIGHT FOR MONITORING. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22178847 ↗
• MalfunctionMay 6, 2025Break; Stretched; Break; Stretched

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A MILDLY CALCIFIED, SUPERFICIAL FEMORAL ARTERY. ONCE THE .018 HT STEEL CORE GUIDEWIRE WAS PLACED IMAGING WAS PERFORMED AND IT APPEARED THAT THE COIL TIP HAD UNRAVELED AND SEPARATED. THEREFORE, DEVICE WAS REMOVED AND NOTED TO STILL BE INTACT; HOWEVER, SEPARATED FROM THE CORE WITH THE TIP COILS STRETCHED. A NEW HT STEELCORE GUIDEWIRE WAS ADVANCED AND HAD THE SAME ISSUE. 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 21969487 ↗

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