PTFE Peelable Introducer Kit 667087-303Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00802526527807), received between Jan 29, 2016 and Sep 6, 2016 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Material Separation” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 6, 2016Material Separation; Material Separation

  AS REPORTED THAT DURING THE IMPLANT PROCEDURE, WHEN ELECTROPHYSIOLOGIST (EP) WAS USING THE PTFE PEELABLE INTRODUCER, BEFORE IT WAS INSERTED IN THE VESSEL ACCESS, THE SHEATH "T" HANDLE DETACHED FROM THE TUBE. THE PHYSICIAN FOLLOWED ALL INDICATIONS FOR USE. THE TUBE WAS REMOVED FROM THE PATIENT WITHOUT INCIDENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5928652 ↗
• InjuryMay 23, 2016Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THE PATIENT SUFFERED A PNEUMOTHORAX FOLLOWING PACEMAKER INSERTION. THE PATIENT WAS STABLE AND DOING WELL THE FOLLOWING MORNING. NO FURTHER INFORMATION WAS PROVIDED IN REGARDS TO DISCHARGE FROM THE HOSPITAL. PATIENT INFORMATION IS UNAVAILABLE.

  Patient problems: Pneumothorax

  MAUDE report 5673054 ↗
• MalfunctionFeb 25, 2016Material Separation; Material Separation

  INFORMATION WAS RECEIVED THAT DURING THE IMPLANT PROCEDURE, THE CEPHALIC VEIN PUNCTURE WAS PERFORMED. WHEN REMOVING THIS INTRODUCER, A BREAKAGE OCCURRED; THE INTRODUCER DID NOT PEEL APART APPROPRIATELY. THE PHYSICIAN USED TWEEZERS TO REMOVE THE BROKEN INTRODUCER. THE PROCEDURE WAS COMPLETED WITH NO FURTHER COMPLICATIONS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5460516 ↗
• InjuryJan 29, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT WHEN PUNCTURING DURING IMPLANT A PNEUMOTHORAX OCCURRED. THE DOCTOR ASSUMES THE PNEUMOTHORAX WAS CAUSED BY THE PUNCTURE WITH THE GUIDING CATHETER. PATIENT INFORMATION IS UNAVAILABLE.

  Patient problems: Pneumothorax

  MAUDE report 5398728 ↗