Peel-Apart Percutaneous Introducer Kit 0601170Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741038327), received between Apr 6, 2016 and Apr 16, 2020 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Fracture” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 16, 2020Fracture; Fracture

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATES THAT MODEL 0601170 PTFE PEEL-APART INTRODUCERS ALLEGEDLY EXPERIENCED A FRACTURE. THE INFORMATION WAS RECEIVED FROM ONE SOURCE. ONE PATIENT WAS INVOLVED WITH NO REPORTED PATIENT INJURY. THE PATIENT¿S AGE, WEIGHT, AND GENDER WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9967927 ↗
• InjuryJan 6, 2020Fracture; Deformation Due to Compressive Stress; Material Twisted/Bent; Fracture; Deformation Due to Compressive Stress; Material Twisted/Bent

  IT WAS REPORTED THAT DURING PORT DEVICE IMPLANT, THE INTRODUCER NEEDLE ALLEGEDLY BROKE IN THE PATIENT. IT WAS FURTHER REPORTED THAT IMAGING ALLEGEDLY IDENTIFIED PNEUMOTHORAX. REPORTEDLY, THE BROKEN PART OF THE NEEDLE WAS REMOVED AND INTERVENTION WAS REQUIRED TO REMOVE THE PORT DEVICE. THE PATIENT WAS REPORTED AS STABLE.

  Patient problems: Pneumothorax

  MAUDE report 9554252 ↗
• MalfunctionApr 19, 2019Defective Component; Material Deformation; Defective Component; Material Deformation

  THIS REPORT SUMMARIZES ONE MALFUNCTION EVENT. A REVIEW OF THE EVENT INDICATED THAT MODEL 0601170 PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR ALLEGEDLY KINKED. THIS REPORT WAS RECEIVED FROM A SINGLE SOURCE. OF THE ONE EVENT, DID INVOLVE PATIENT WITH NO REPORTED PATIENT INJURY. THE PATIENTS AGE, WEIGHT AND GENDER WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8532868 ↗
• InjuryJun 21, 2017Break; Detachment Of Device Component

  IT WAS REPORTED THE CLAVICULAR BONE WAS PUNCTURED AND WHILE MANIPULATING THE NEEDLE, ONE PART GOT STUCK IN THE PATIENT. THE NEEDLE BROKE INTO TWO PIECES. THERE WERE NO PROBLEMS REMOVING THE BROKEN PART FROM THE PATIENT.

  Patient problems: Foreign Body In Patient; Needle Stick/Puncture

  MAUDE report 6656645 ↗
• MalfunctionApr 6, 2016Kinked; Stretched

  ON 03/16/2016 - BAS ENGINEERS FOUND ADDITIONAL GUIDEWIRE RETURNED FOR EVALUATION. THE GUIDEWIRE IS INTACT AT BOTH ENDS AND BLOOD RESIDUE IS EVIDENT. THE GUIDEWIRE IS KINKED IN TWO PLACES. IT IS STRETCHED AND A SEGMENT OF THE WRAPPING IS MISSING. ON 03/18/2016 - BASED ON THE ORIGINAL EVENT, THE PATIENT HAD PAIN AND THERE ARE RISKS OF INJURY TO THE VEIN AND OF LOSS OF PART OF THE GUIDEWIRE IN THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5552871 ↗