Peel-Apart Percutaneous Introducer Kit 0607780Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00801741038358), received between Apr 8, 2016 and Feb 26, 2026 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 26, 2026Fracture; Air/Gas in Device

  A PATIENT UNDERWENT A PORT CATHETER REPLACEMENT PROCEDURE USING THE PTFE PEEL APART INTRODUCER. DURING THE PROCEDURE, AIR ALLEGEDLY LEAKED AND WAS UNABLE TO REPLENISH BLOOD. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24465774 ↗
• MalfunctionJul 21, 2025Unsealed Device Packaging; Device Damaged Prior to Use; Device Contamination with Chemical or Other Material; Material Integrity Problem; Unsealed Device Packaging; Device Damaged Prior to Use; Device Contamination with Chemical or Other Material; Material Integrity Problem

  A PATIENT WAS PREPPED FOR A PORT PLACEMENT PROCEDURE AND IT WAS FOUND THAT THE PTFE PEEL-APART PERCUTANEOUS INTRODUCER KIT ALLEGEDLY DAMAGED UPON DELIVERY. FURTHER IT WAS NOTED THAT THERE WAS OIL LOOKING STAIN ON PACKAGE WHICH WAS CLEARLY A CONTAMINATION. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22552912 ↗
• MalfunctionApr 15, 2024Fracture; Deformation Due to Compressive Stress; Fracture; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT DURING A CHRONIC CATHETER PLACEMENT PROCEDURE, THE MID SHEATH WAS ALLEGEDLY FRACTURED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19109829 ↗
• MalfunctionDec 2, 2021Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A PORT PLACEMENT PROCEDURE, THE SHEATH WAS ALLEGEDLY ABNORMALLY TIGHT. IT WAS FURTHER REPORTED THAT THE CARD WAS NOT TIGHT. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12916548 ↗
• MalfunctionDec 2, 2021Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A PORT PLACEMENT PROCEDURE, THE SHEATH WAS ALLEGEDLY ABNORMALLY TIGHT. IT WAS FURTHER REPORTED THAT THE CARD WAS NOT TIGHT. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12916501 ↗
• MalfunctionApr 19, 2019Material Frayed; Defective Component; Material Frayed; Defective Component

  THIS REPORT SUMMARIZES ONE (1) MALFUNCTION EVENT. A REVIEW OF THE EVENT INDICATED THAT MODEL 0607780 IMPLANTABLE PORT EXPERIENCED A DEFECTIVE COMPONENT. THIS EVENT WAS REPORTED FROM A SINGLE SOURCE. THIS EVENT INVOLVED A PATIENT WITH NO REPORTED INJURY. THE PATIENT¿S AGE, WEIGHT, AND SEX WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8532597 ↗
• MalfunctionAug 11, 2016Bent

  REPORTED THE END OF THE NEEDLE WAS BENT. USED A NEW DEVICE TO COMPLETE THE PROCEDURE. ON 7/22/2016 - THE NEEDLE WAS RETURNED WITH A GUIDEWIRE LODGED INSIDE. THERE WAS NO BEND IN THE NEEDLE BUT THE GUIDEWIRE WAS BENT. THE GUIDEWIRE WAS ALSO FRAYED. THE FRAYED PORTION OF THE GUIDEWIRE WAS RETAINED WITHIN THE NEEDLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5870289 ↗
• MalfunctionJul 25, 2016Difficult to Insert; Split

  HEALTH PROFESSIONAL REPORTED THAT THERE WERE NO ANOMALIES WHEN THEY OPENED THE PACKAGE OF THE INTRODUCER KIT. THE USER INSERTED THE GUIDEWIRE IN THE PATIENT AND FOUND THAT INSERTION WAS DIFFICULT. THE USER THEN RETRACTED THE DEVICE AND FOUND THAT THE TIP OF THE GUIDEWIRE WAS SPLIT. ANOTHER KIT WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5818928 ↗
• MalfunctionApr 8, 2016Device Operates Differently Than Expected

  THE TIP OF THE GUIDE WIRE WAS REPORTEDLY TOO SOFT TO USE. ANOTHER ONE WAS USED TO COMPLETE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5563086 ↗