NA 72202810Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00885554000207), received between Jul 29, 2019 and May 12, 2021 — classified as 18 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (14 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.

• MalfunctionMay 12, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE GUIDEWIRE RUBBER NIB PROTECTOR WOULD NOT COME OFF. THE INCIDENT OCCURRED BEFORE THE PROCEDURE. THERE WAS NO SIGNIFICANT DELAY AND A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11810541 ↗
• MalfunctionApr 27, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT, DURING SET UP FOR SURGERY, THE PLASTIC TIPS ON THE END OF THE "GUIDEWIRE 1.5 X 229" SEEMED ALMOST MELTED ON AND COULD NOT GET OFF. A SCALPEL HAD TO BE USED. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE. THERE WERE NO SIGNIFICANT DELAYS AND NO PATIENT INJURIES OR OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11734607 ↗
• MalfunctionApr 25, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT, DURING SET UP FOR AN ARTHROSCOPY PROCEDURE, THE PLASTIC TIPS ON THE END OF THE GUIDEWIRE SEEMED MELTED ON. A SCALPEL HAD TO BE USED TO GET THEM OFF. A BACKUP DEVICE WAS AVAILABLE AND NO PATIENT INJURY WAS REPORTED. A DELAY EQUAL TO OR LESS THAN 30 MINUTES WAS REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11722064 ↗
• MalfunctionApr 25, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT, DURING SET UP FOR AN ARTHROSCOPY PROCEDURE, THE PLASTIC TIPS ON THE END OF THE GUIDEWIRE SEEMED MELTED ON. A SCALPEL HAD TO BE USED TO GET THEM OFF. A BACKUP DEVICE WAS AVAILABLE AND NO PATIENT INJURY WAS REPORTED. A DELAY EQUAL TO OR LESS THAN 30 MINUTES WAS REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11722063 ↗
• MalfunctionApr 11, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE PLASTIC TIPS ON END OF THE GUIDEWIRE SEEMED ALMOST MELTED ON AND IT COULD NOT GET OFF. A SCALPEL WAS USED TO REMOVED IT. INCIDENT OCCURRED WHILE SETTING-UP TO THE PROCEDURE. A BACK-UP DEVICE WAS AVAILABLE AND NO SIGNIFICANT DELAY OCCURRED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11646793 ↗
• MalfunctionApr 11, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE PLASTIC TIPS ON END OF THE GUIDEWIRE SEEMED ALMOST MELTED ON AND IT COULD NOT GET OFF. A SCALPEL WAS USED TO REMOVED IT. INCIDENT OCCURRED WHILE SETTING-UP TO THE PROCEDURE. A BACK-UP DEVICE WAS AVAILABLE AND NO SIGNIFICANT DELAY OCCURRED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11646787 ↗
• MalfunctionMar 17, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING ARTHROSCOPY PROCEDURE, OUTSIDE THE PATIENT, USING GUIDEWIRE THE SILICONE PLUG AT THE TIP OF THE SPIKE IS STUCK (MELTED). THE PROCEDURE FINISHED WITH A SMITH AND NEPHEW BACKUP DEVICE. SURGICAL DELAY LESS THAN OR EQUAL TO 30 MINS PATIENT INJURIES WERE NOT REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11506788 ↗
• MalfunctionMar 17, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING ARTHROSCOPY PROCEDURE, OUTSIDE THE PATIENT, USING GUIDEWIRE THE SILICONE PLUG AT THE TIP OF THE SPIKE IS STUCK (MELTED). THE PROCEDURE FINISHED WITH A SMITH AND NEPHEW BACKUP DEVICE. SURGICAL DELAY LESS THAN OR EQUAL TO 30 MINS PATIENT INJURIES WERE NOT REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11506785 ↗
• MalfunctionMar 17, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING ARTHROSCOPY PROCEDURE, OUTSIDE THE PATIENT, USING GUIDEWIRE THE SILICONE PLUG AT THE TIP OF THE SPIKE IS STUCK (MELTED). THE PROCEDURE FINISHED WITH A SMITH AND NEPHEW BACKUP DEVICE. SURGICAL DELAY LESS THAN OR EQUAL TO 30 MINS PATIENT INJURIES WERE NOT REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11506784 ↗
• MalfunctionMar 3, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING A SURGERY, IT WAS NOTICED THAT THE GUIDEWIRE HAD PROBLEMS WITH THE SILICONE SHIELD SINCE IT HAD MELTED AND IT WAS DIFFICULT TO BE REMOVED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT A SIGNIFICANT DELAY USING THE SAME DEVICE. NO PATIENT INJURY OR COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11407738 ↗
• MalfunctionMar 3, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING A SURGERY, IT WAS NOTICED THAT THE GUIDEWIRE HAD PROBLEMS WITH THE SILICONE SHIELD SINCE IT HAD MELTED AND IT WAS DIFFICULT TO BE REMOVED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT A SIGNIFICANT DELAY USING THE SAME DEVICE. NO PATIENT INJURY OR COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11407725 ↗
• MalfunctionMar 3, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING A SURGERY, IT WAS NOTICED THAT THE GUIDEWIRE HAD PROBLEMS WITH THE SILICONE SHIELD SINCE IT HAD MELTED AND IT WAS DIFFICULT TO BE REMOVED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT A SIGNIFICANT DELAY USING THE SAME DEVICE. NO PATIENT INJURY OR COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11407584 ↗
• MalfunctionMar 3, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING A SURGERY, IT WAS NOTICED THAT THE GUIDEWIRE SILICONE SHIELD HAS PROBLEMS WITH THE SILICONE SHIELD. IT SEEMS THAT THE SILICONE HAD MELTED AND IT WAS DIFFICULT TO BE REMOVED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT A SIGNIFICANT DELAY USING THE SAME DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11407443 ↗
• MalfunctionMar 3, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING A SURGERY, IT WAS NOTICED THAT THE GUIDEWIRE HAD PROBLEMS WITH THE SILICONE SHIELD SINCE IT HAD MELTED AND IT WAS DIFFICULT TO BE REMOVED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT A SIGNIFICANT DELAY USING THE SAME DEVICE. NO PATIENT INJURY OR COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11406455 ↗
• MalfunctionNov 24, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT, DURING AN ACL REVISION SURGERY, THE RUBBER ENDS OF THE "GUIDEWIRE (1.5X229)" COULD NOT BE REMOVED EASILY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SIGNIFICANT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURIES OR OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10895131 ↗
• MalfunctionNov 20, 2020Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A KNEE PROCEDURE THE PLASTIC ENDS OF THE GUIDE WIRE WAS NOT ABLE TO BE REMOVED COMPLETELY. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE. NO SIGNIFICANT DELAY AND NO PATIENT INJURIES WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10879764 ↗
• MalfunctionNov 19, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING SETUP FOR AN ARTHROSCOPY AFTER OPENING THE GUIDE WIRE, IT WAS OBSERVED THAT THE RUBBER PROTECTOR ON EITHER END WERE MELTED AND COULD NOT BE SUCCESSFULLY REMOVED, EVEN WITH THE NURSING STAFF USING A SCALPEL. THERE WAS BACKUP DEVICE AVAILABLE AND NO DELAY OR FURTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Patient Involvement

  MAUDE report 10871252 ↗
• MalfunctionJul 29, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING SURGERY, THE RUBBER PROTECTION COVERING THE ENDS OF THE GUIDE WIRE OF THE SCREW WAS NOT REMOVED AND WAS FUSED WITH IT; IN THIS WAY THE GUIDE WIRE WAS UNUSABLE, BECAUSE THE RUBBER CANNOT BE REMOVED. THE ATTEMPT WAS MADE WITH MULTIPLE WIRES OF THE SAME LOT. THE PROCEDURE WAS COMPLETED WITH A COMPETITOR DEVICE. NO DELAY OR PATIENT INJURIES WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8838780 ↗