SV WIRERecalls & reported problems across all models

We found 4 models of SV WIRE by Cordis Corporation in the FDA's device registry (GUDID). Together they are named in 60 adverse event reports in the FDA's MAUDE database, received between Nov 18, 2016 and Sep 15, 2026 — classified as 13 injuries, 47 malfunctions.

The most frequently reported specific device problem is “Fracture” (41 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 SV WIRE problems

SV WIRE models

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

• SV WIRE 503558X

  Wire, guide, catheter
  32 reports
• SV WIRE 503558

  Wire, guide, catheter
  21 reports
• SV WIRE 503658X

  Wire, guide, catheter
  5 reports
• SV WIRE 503658

  Wire, guide, catheter
  2 reports

Recent SV WIRE adverse event reports

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

• MalfunctionSep 15, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50779047 ↗
• MalfunctionSep 15, 2026Detachment of Device or Device Component

  As reported, there was damage to two .018 300cm SV-5 straight tip guidewires. The guidewire was fractured at the distal tip, and the damage was observed after use inside the patient. The guidewires did not separate into two pieces. Both guidewires fractured but remained intact without separated pieces. The fractures resulted in the guidewires failing to provide the support needed to cross the lesion. The guidewire was replaced with a non-Cordis .035 guidewire. There were no reported injuries to the patient. The devices were stored according to the instructions for use (IFU). No damage to the device packaging or guidewire hoops was reported prior to opening. The wires were not removed from their dispensers by the distal floppy end; they were removed from the proximal portion at the catheter hub. The devices will not be returned for evaluation.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50778872 ↗
• MalfunctionJul 27, 2026Fracture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50042597 ↗
• MalfunctionJul 9, 2026Fracture

  AS REPORTED, DURING USE OF THE THREE .018 SV SHORT 300CM SV GUIDEWIRES, THAT THE DISTAL TIP PORTION OF THE GUIDEWIRE WAS TORN AND DETACHED. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE DEVICES WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25762070 ↗
• MalfunctionJul 9, 2026Fracture

  AS REPORTED, DURING USE OF THE THREE .018 SV SHORT 300CM SV GUIDEWIRES, THAT THE DISTAL TIP PORTION OF THE GUIDEWIRE WAS TORN AND DETACHED. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE DEVICES WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25762065 ↗
• MalfunctionJun 10, 2024Fracture; Fracture

  AS REPORTED, THE PROXIMAL PART OF THE .018 180CM SV WIRE WAS STRIPED. IT WAS NOTED TO HAVE COME OFF AS A SPIRAL. THE DAMAGE WAS NOTED TO BE DURING USE (INSIDE OF THE PATIENT) AND AFTER WITHDRAWAL FROM THE PATIENT. THE GUIDEWIRE WAS EASILY REMOVED FROM THE PATIENT. A NEW UNKNOWN STIFFER WIRE WAS USED TO COMPLETE THE CASE. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE WIRE WAS ¿NORMAL¿ WHEN REMOVED FROM THE PACKAGE AND INSERTED INTO THE PATIENT. THE DEVICE WAS STORED, HANDLED, AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU). THE TIP OF THE GUIDEWIRE WAS NOT SHAPED AT ANY POINT DURING THIS PROCEDURE. THE LESION WAS IN THE PROXIMAL PORTION OF THE SUPERFICIAL FEMORAL ARTERY (SFA). THE VESSEL HAD MODERATE TORTUOSITY AND THE LESION WAS NOTED TO HAVE MODERATE CALCIFICATION. THE GUIDEWIRE WAS NOT BEING USED WITH ANOTHER DEVICE WHEN THE DAMAGE OCCURRED. THE DEVICE WILL BE RETURNED FOR EVALUATION. ADDITIONAL INFORMATION WAS REQUESTED; HOWEVER, THE INFORMATION WAS NOT OBTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19506881 ↗
• MalfunctionApr 30, 2024Fracture; Fracture

  AS REPORTED, WHEN REMOVING THAT .018 SV SHORT 300CM WIRE DURING AN ANGIO CASE, THE TIP SEPARATED FROM THE REST OF WIRE. IT STAYED ATTACHED TO THE BASE OF WIRE BY A VERY THIN STRAND. THE TEAM WAS ABLE TO REMOVE THE ENTIRE WIRE WITHOUT LOSING THE TIP THAT SEPARATED. THE FACILITY HAD TWO MORE BOXES OF FIVE WITH THE SAME LOT NUMBER THAT THEY (THE FACILITY) PULLED FROM THE SHELF. THERE WAS NO DAMAGE TO THE PACKAGING OF THE DEVICE. THERE WERE NO ANOMALIES NOTED PRIOR TO REMOVING THE DEVICE FROM THE PACKAGING. THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP. THE DEVICE WAS STORED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE DEVICE WAS PREPPED PER THE IFU. THERE WERE NO KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT INTO THE PATIENT. EXCESS FORCE WAS NOT APPLIED DURING INSERTION. THE LESION WAS IN THE POPLITEAL ARTERY. THE FEMORAL ARTERY WAS USED FOR ACCESS. THE DEVICES WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19215562 ↗
• MalfunctionNov 8, 2023Fracture; Fracture

  AS REPORTED, THE ¿COIL PART¿ OF A 0.018" STRAIGHT TIP SV SHORT 180CM PERIPHERAL STEERABLE GUIDEWIRE (PGW) GOT STRETCHED DURING USE, THE COMPLAINT DEVICE WAS REPLACED WITH ANOTHER UNKNOWN DEVICE AND THE PROCEDURE CONTINUED. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS BEING USED IN A PEDIATRIC PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CASE. MULTIPLE ATTEMPTS TO OBTAIN SUPPLEMENTAL INFORMATION WERE MADE; HOWEVER, ADDITIONAL EVENT DETAILS WERE NOT PROVIDED. THE DEVICE WAS EXPECTED TO BE RETURNED FOR EVALUATION; HOWEVER, NO PRODUCT RETURN INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18097237 ↗
• MalfunctionJul 7, 2023Fracture; Material Frayed; Fracture; Material Frayed

  AS REPORTED, THE DISTAL TIP OF A .018 180CM SV STRAIGHT TIP 8CM DISTAL TAPER GUIDEWIRE WAS FOUND FRAYED WHILE INSIDE OF THE PATIENT. THE SV - 8 GUIDEWIRE WAS REMOVED IN ONE PIECE, AND AN UNKNOWN GUIDEWIRE WAS USED AS A REPLACEMENT TO CONTINUE THE PROCEDURE. THERE WAS NO REPORTED INJURY TO THE PATIENT AND THE PATIENT SHOWED NO SIGNS OF INFECTIOUS DISEASE. THE DEVICE WAS STORED, HANDLED, AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU) AND WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17277072 ↗
• MalfunctionJun 30, 2023Fracture; Fracture

  AS REPORTED, THE COIL PART OF A .018 SHORT 180CM SV STEERABLE GUIDEWIRE RELEASED FROM THE CORE PART. THE GUIDEWIRE WAS REPLACED WITH ANOTHER UNKNOWN DEVICE AND THE PEDIATRIC PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE CONTINUED. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WILL BE RETURNED FOR EVALUATION. ADDENDUM: AS PER THE PRODUCT EVALUATION, A FRACTURED/SEPARATED AREA OF THE CORE WIRE OF THE UNIT PRESENTED EVIDENCE OF PLASTIC DEFORMATION ON THE DAMAGED END AREA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17239493 ↗
• InjuryJun 23, 2023Fracture; Fracture

  MULTIPLE ATTEMPTS TO OBTAIN SUPPLEMENTAL INFORMATION WERE MADE; HOWEVER, ADDITIONAL EVENT DETAILS WERE NOT PROVIDED. THE DEVICE WAS EXPECTED TO BE RETURNED FOR EVALUATION; HOWEVER, NO PRODUCT RETURN INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17190661 ↗
• MalfunctionMay 15, 2023Fracture; Fracture

  AS REPORTED, THE COIL WIRE PART (SOFT TIP TO HARD TIP CONNECTION) OF A .018 SV STEERABLE 300CM STRAIGHT GUIDEWIRE HAS BEEN STRETCHED AND BROKEN "FREQUENTLY LATELY." THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS STORED IN AN APPROPRIATE CABINET, HANDLED, AND PREPPED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU). THERE WERE NO ANOMALIES NOTED WHEN REMOVED FROM THE PACKAGE. THE WIRE WAS NOT REMOVED FROM THE DISPENSER BY THE DISTAL FLOPPY END. THE INTENDED TARGET LESION WAS IN A CHILD¿S CARDIAC ARTERY. THE DEVICE WAS FLUSHED PRIOR TO USE. ADDITIONAL PROCEDURAL DETAILS WERE REQUESTED BUT ARE UNKNOWN. THE DEVICE WILL BE RETURNED FOR EVALUATION. ADDENDUM: A FRACTURED/SEPARATED CONDITION WAS OBSERVED ON THE CORE WIRE WITH THE COILED WIRE NOTED TO BE ATTACHED TO THE UNIT. THE SEPARATED PORTION OF THE WIRE WAS NOT RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16932323 ↗
• MalfunctionMay 8, 2023Fracture; Fracture

  AS REPORTED, THE DISTAL TIP OF A .018 5 CM 300 CM STRAIGHT TIP SV STEERABLE GUIDEWIRE WAS FOUND FRACTURED AFTER REMOVAL. APPROXIMATELY 10-15 MM FROM THE DISTAL END THE DEVICE SEPARATED. A NON-CORDIS .018 GLIDE WIRE WAS ADVANCED, AND A NON-CORDIS STENT WAS SUCCESSFULLY DEPLOYED. THE PHYSICIAN REMOVED SOME OF THE GUIDEWIRE VIA AN UNKNOWN NON-CORDIS MICRO SNARE. THE REMAINING PORTION OF THE GUIDEWIRE WAS TRAPPED BETWEEN A NON-CORDIS STENT AND THE ARTERY WALL AS THEY INTENDED ON USING THAT DEVICE FOR PATIENT TREATMENT. NO FUTURE COMPLICATIONS WERE NOTED. A 7F SHEATH WAS ADVANCED INTO PLACE. AFTER CROSSING THE CAROTID ARTERY WITH THE DEVICE, A NON-CORDIS STENT WAS ADVANCED UNSUCCESSFULLY. THEN A .018 NON-CORDIS GLIDE WIRE WAS ADVANCED, AND A NON-CORDIS WAS STENT WAS SUCCESSFULLY DEPLOYED. THE WIRE WAS NOT REMOVED FROM THE DISPENSER BY THE DISTAL FLOPPY END. THE DEVICE WAS NOT USED FOR A CHRONIC TOTAL OCCLUSION (CTO). THE GUIDEWIRE MANIPULATION/TORQUING WAS PERFORMED UNDER FLUOROSCOPIC GUIDANCE. THERE WAS NO RESISTANCE ENCOUNTERED WHILE ADVANCING OR WITHDRAWING THE GUIDEWIRE. THE GUIDEWIRE DID NOT BECOME ENTRAPPED AT ANY POINT IN THE PROCEDURE. THE DEVICE WAS NOT BEING USED ON HIGHLY TOR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16885046 ↗
• InjuryMay 5, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, THE DISTAL END OF THE 0.018" 300CM SV SHORT PERIPHERAL STEERABLE GUIDEWIRE (PGW) GOT TRAPPED IN THE PULMONARY ARTERY (PA). THE PHYSICIAN ATTEMPTED TO REMOVE THE COMPLAINT DEVICE AS TENSION WAS APPLIED BUT THE COMPLAINT DEVICE GOT SEPARATED. THE PHYSICIAN ATTEMPTED TO REMOVE THE SEPARATED COMPLAINT DEVICE BY USING A SNARE CATHETER, BUT THE SNARE CATHETER ALSO GOT TRAPPED IN THE PULMONARY ARTERY AND THE SNARE WIRE PART GOT SEPARATED. THE DISTAL END OF THE COMPLAINT DEVICE AND THE SNARE WIRE PART WERE UNABLE TO BE REMOVED AND THE PROCEDURE WAS TERMINATED. THIS WAS A PEDIATRIC PULMONARY ARTERY (PA) EXPANSION CASE. THERE WERE 2 COMPLAINT DEVICES USED FOR PA DILATATION. ON THE LEFT PA A 0.18 SV SHORT GUIDEWIRE 180 CM LOT 35264005 WAS USED BUT BECAME UNRAVELED BUT WAS RETRIEVED; A SNARE WAS USED TO GRAB THE DISTAL PART OF THE DEVICE. (REFER TO (B)(4)). A 0.018" 300CM SV SHORT PERIPHERAL STEERABLE GUIDEWIRE LOT 35265675 WAS USED ON THE RIGHT PULMONARY ARTERY. SINCE THE FIRST COMPLAINT DEVICE WAS UNRAVELED, THE PHYSICIAN USED THIS TO EXPAND THE PA BALLOON. AFTER COMPLETION OF DILATION AND CONFIRMATION ANGIOGRAPHY AFTER REMOVAL OF THE BALLOON, THERE WAS AN INTENSIVE RESISTANCE F

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16875295 ↗
• MalfunctionApr 4, 2023Material Frayed; Material Frayed

  AS REPORTED, THE DISTAL TIP OF A .018¿ 180CM STRAIGHT (ST) SV PERIPHERAL STEERABLE GUIDEWIRE (PGW) WAS GETTING FRAYED WHEN ATTEMPTING TO CROSS THE LESION. THE COMPLAINT DEVICE WAS REPLACED WITH ANOTHER UNKNOWN DEVICE AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS DISCARDED AND WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16678227 ↗

Other Cordis Corporation products

• ANGIOGUARD7 models · 44 reports · 6 recalls
• TEMPO56 models · 250 reports
• INFINITI22 models · 144 reports · 1 recall
• SABER40 models · 185 reports
• AVANTI19 models · 108 reports · 1 recall
• POWERFLEX34 models · 151 reports
• VISTA BRITE TIP26 models · 59 reports · 1 recall
• SUPER TORQUE11 models · 109 reports