HI-TORQUE STEELCORE 1007710Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 08717648014123), received between Mar 21, 2017 and Oct 22, 2025 — classified as 4 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (5 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 18, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• MalfunctionFeb 16, 2024Off-Label Use; Difficult to Remove; Difficult to Advance; Off-Label Use; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS A CARDIOMEMS IMPLANT PROCEDURE. THE CATHETER WAS FLUSHED AND THE STEELCORE GUIDE WIRE WAS ADVANCED INTO THE TARGET VESSEL. THE SHEATH AND WIRE WERE FLUSHED AND WIPED PRIOR TO ADVANCING THE FULLY PREPPED CARDIOMEMS DELIVERY SYSTEM. DURING ADVANCEMENT TO THE TARGET LESION, IT WAS NOTED THAT THE DELIVERY SYSTEM WAS NOT ADVANCING WELL OVER THE STEELCORE GUIDE WIRE TO THE TARGET LOCATION IN THE CORRECT MANNER. THEREFORE, THE SENSOR AND DELIVERY SYSTEM WERE REMOVED AS A UNIT. THE PULMONARY WEDGE CATHETER WAS REINSERTED AND THE STEELCORE GUIDE WIRE WOULD NOT PASS THROUGH THE HUB OF THE PULMONARY WEDGE CATHETER. A NEW STEELCORE GUIDEWIRE AND CARDIOMEMS DELIVERY SYSTEM WERE USED TO COMPLETE THE PROCEDURE. THE PATIENT EXPERIENCED HEMOPTYSIS DUE TO THE SECOND STEELCORE GUIDE WIRE BUT THIS RESOLVED ON ITS OWN WITHOUT INTERVENTION. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18723021 ↗
• InjuryFeb 8, 2024Off-Label Use; Adverse Event Without Identified Device or Use Problem; Off-Label Use; Adverse Event Without Identified Device or Use Problem

  HOLD FOR RW 2.8 IT WAS REPORTED THAT THE PROCEDURE WAS A CARDIOMEMS SENSOR PLACEMENT WITH A STEELCORE GUIDE WIRE. THE SENSOR WAS SUCCESSFULLY DEPLOYED AND THEN THE PATIENT EXPERIENCED A TRACE AMOUNT OF HEMOPTYSIS WHICH WAS POTENTIALLY DUE TO THE STEELCORE GUIDE WIRE. THE PATIENT WAS TRANSFERRED TO THE STRETCHER AND THE HEAD OF THE BED WAS ELEVATED. THE HEMOPTYSIS WAS RESOLVED. THE 12FR SHEATH WAS REMOVED AND THE PATIENT REMAINED ON THE MONITOR IN THE CATH LAB. FOLLOWING SHEATH REMOVAL, THE PATIENT WAS MOVED TO RECOVERY AND EXPERIENCED NO FURTHER ISSUES. A CHEST XRAY WAS ORDERED AND THE PATIENT WAS KEPT OVERNIGHT FOR OBSERVATION. THE XRAY WAS FOUND TO BE CLEAR AND THE PATIENT WAS DISCHARGED THE NEXT DAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18669854 ↗
• InjuryNov 1, 2022Difficult to Remove; Material Too Soft/Flexible; Difficult to Remove; Material Too Soft/Flexible

  IT WAS REPORTED THAT DURING A CARDIOMEMS IMPLANTATION PROCEDURE, THE HT STEELCORE 18 GUIDE WIRE (GW) PROLAPSED IN THE LOWER BRANCH OF THE LEFT PULMONARY ARTERY. RESISTANCE WAS NOTED DURING REMOVAL OF THE WIRE. AT SOME POINT, THE PATIENT STARTED TO COUGH UP BLOOD. IT WAS THOUGHT THAT THE WIRE LIKELY CAUSED A SMALL PERFORATION IN THE PULMONARY ARTERY AT THE TIME OF REMOVAL. HEPARIN REVERSAL WAS ADMINISTERED AND THE PATIENT WAS SUCTIONED UNTIL THE BLOOD BEGAN TO CLOT. THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT, THEN THE STEP DOWN UNIT FOR MONITORING OVERNIGHT. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Perforation of Vessels

  MAUDE report 15712550 ↗
• MalfunctionAug 24, 2022Break; Stretched; Break; Stretched

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LEFT PULMONARY ARTERY. THE NON-ABBOTT GUIDE CATHETER WAS PLACED AND 018 STEELCORE GUIDE WIRE WAS ADVANCED DISTALLY FROM THE GUIDE CATHETER TO SERVE AS A GUIDE FOR THE CARDIOMEMS DELIVERY SYSTEM TO BE PLACED. A "GAP" WAS NOTED ON THE XRAY IN THE DISTAL TIP OF THE GUIDE WIRE. THE GUIDE CATHETER WAS ADVANCED AND THE GUIDE WIRE PULLED INTO THE GUIDE CATHETER AND REMOVED WITHOUT ISSUE. ONCE OUTSIDE THE ANATOMY THE GUIDE WIRE COVERING "COILS" LOOKED FRAYED AND UNRAVELING. A NEW GUIDE CATHETER AND GUIDE WIRE USED TO PREPARE FOR THE CARDIOMEMS PLACEMENT. THERE WAS NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15283195 ↗
• MalfunctionMay 4, 2021Product Quality Problem; Difficult to Remove; Difficult to Advance; Product Quality Problem; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT DURING ADVANCEMENT OF THE CARDIOMEMS SENSOR DELIVERY CATHETER OVER A STEELCORE GUIDE WIRE, RESISTANCE WAS NOTED. AFTER THE SENSOR WAS DEPLOYED AND DURING REMOVAL OF THE CARDIOMEMS DELIVERY SYSTEM, RESISTANCE WITH THE GUIDE WIRE WAS NOTED CAUSING THE CARDIOMEMS SENSOR TO PULL BACK. FORCE WAS APPLIED TO REMOVE THE DELIVERY CATHETER AND ANOTHER DEVICE WAS ADVANCED OVER THE WIRE TO ASSIST WITH THE FINAL IMPLANTATION OF THE SENSOR. ALL DEVICES REMOVED AFTER THE SENSOR WAS IMPLANTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11773971 ↗
• InjuryMar 21, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH A PERFORATION WITH EXTRAVASATION IN THE LEFT RENAL ARTERY JUST DISTAL TO A DEPLOYED 5.0X50MM NON-ABBOTT COVERED STENT FOR TREATMENT OF AN EXISTING ANEURYSM. REPORTEDLY, THE PERFORATION WAS MOST LIKELY CAUSED BY A HI-TORQUE (HT) STEELCORE 18 LT 300CM GUIDE WIRE (GW); WHILE THERE WERE NO DEVICE ISSUES AND THE GW WAS EASILY ADVANCED, IT CAUSED A DISSECTION WHICH BECAME A PERFORATION. AN ATTEMPT WAS MADE TO ADVANCE ANOTHER NON-ABBOTT COVERED STENT OVER THE HT STEELCORE GW, BUT THE STENT FAILED TO ADVANCE DUE TO PATIENT ANATOMY. THE STENT AND STEELCORE GW WERE WITHDRAWN AND A SMALLER GW (SPARTACORE 14 ST 5.0X300CM) WAS ADVANCED. A 4.5X26MM RX GRAFTMASTER COVERED STENT WAS THEN SUCCESSFULLY ADVANCED OVER THE SPARTACORE AND WAS DEPLOYED OVERLAPPING THE DISTAL END OF THE NON-ABBOTT COVERED STENT, SUCCESSFULLY SEALING THE PERFORATION. A 5.0X28MM RX ULTRA BARE METAL STENT (BMS) WAS THEN SUCCESSFULLY DEPLOYED INSIDE OF THE NON-ABBOTT COVERED STENT (BUT NOT IN THE GRAFTMASTER) PER ROUTINE PROCEDURE TO ENSURE OPTIMAL APPOSITION AND SEALING OF ONLY THE NON-ABBOTT STENT, FOLLOWED BY POST-DILATATION WITH A NON-ABBOTT BALLOON. A FINAL ANGIOGRAM CONFIR

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Intimal Dissection; Perforation

  MAUDE report 6422312 ↗