Portex 100/562/000CZRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 15019315106750), received between Feb 22, 2019 and May 12, 2023 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Fitting Problem” (2 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryMay 12, 2023Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THE GUIDEWIRE DOES NOT FIT IN THE NEEDLE. THE RED INTRODUCER COULD NOT PROPERLY STRAIGHTEN THE ROUND END OF THE GUIDEWIRE. THE CANNULA WAS NOT INSERTED WITH THE NEEDLE. THERE WAS AN INCREASE OF PROCEDURE'S DURATION, PATIENT'S BLEEDING AND MECHANIC VENTILATION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16919447 ↗
• InjuryApr 18, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A PERCUTANEOUS TRACHEOSTOMY, THERE WAS A TECHNICAL DIFFICULTY RELATED TO ?BENDING AND DEFORMITY? OF THE ATRAUMATIC GUIDE. THIS DELAY WAS RELATED TO TRANSIENT LOSS OF ACCESS TO THE TRACHEA WITH SECONDARY PATIENT DESATURATION. A TRACHEOSTOMY CANNULA WAS ADVANCED, BUT CANNOT MOVE FORWARD, SO IT HAD TO BE EXTRACTED AND THE PROCEDURE RESTARTED WITH SUBSEQUENT DIFFICULTY IN ENTERING THE TRACHEA. AFTER SEVERAL ATTEMPTS, ANOTHER DEVICE WITHOUT A FENESTRA WAS ADVANCED. DURING THE PERCUTANEOUS TRACHEOSTOMY THE PATIENT PRESENTED A COMPLICATION OF TENSION PNEUMOTHORAX ON THE RIGHT, IT WAS SUSPECTED BY THE CUSTOMER THIS COMPLICATION WAS POSSIBLY DUE TO THE USE OF THE PERCUTANEOUS TRACHEOSTOMY SET. THE CUSTOMER PROVIDED AN INVALID LOT NUMBER FOR THIS ITEM. ICU MEDICAL ATTEMPTED TO OBTAIN A VALID LOT NUMBER AND THE CUSTOMER INFORMED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Pneumothorax

  MAUDE report 16763651 ↗
• MalfunctionMar 15, 2023Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT THE GUIDE WIRE WOULD NOT FIT THROUGH THE ACCESS NEEDLE WITH ANY POSSIBILITY. THERE HAS BEEN NO REPORT OF PATIENT INVOLVEMENT OR NO OBSERVABLE CLINICAL SYMPTOMS OR A CHANGE IN SYMPTOMS IDENTIFIED IN THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 16548089 ↗
• MalfunctionSep 25, 2020Material Deformation; Material Deformation

  CUSTOMER STATES THE CANNULA OFTEN KINKS WHEN THEY TRY TO PUT THE GUIDEWIRE THROUGH CANNULA. THE ACTUAL DEVICE HAS NOT BEEN USED ON A PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement

  MAUDE report 10587688 ↗
• MalfunctionJun 12, 2020Fitting Problem; Fitting Problem

  INFORMATION WAS RECEIVED INDICATING THAT PRIOR TO INSERTION OF A SMITHS MEDICAL PORTEX ULTRAPERC PERCUTANEOUS DILATION TRACHEOSTOMY THE GUIDEWIRE WAS UNABLE TO BE INSERTED INTO THE NEEDLE. IT WAS REPORTED THAT THERE WAS NO CANNULA ON THE NEEDLE. THERE WAS NO REPORTED PATIENT INJURY OR ADVERSE EFFECTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10150595 ↗
• MalfunctionFeb 22, 2019Mechanical Jam; Mechanical Jam

  INFORMATION WAS RECEIVED THAT GUIDEWIRE WAS UNABLE TO BE INSERTED DURING PROCEDURE INTO THE 14G NEEDLE. NEW KIT WAS THEN USED TO RESOLVE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8363634 ↗