Cook G10215Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002102156), received between Jan 11, 2021 and Jan 17, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 17, 2022Break; Contamination; Break; Contamination

  AS REPORTED, UPON OPENING THE PACKAGE OF A PARK PERICARDIOCENTESIS CATHETER TRAY PRIOR TO USE, THE USER FOUND THAT THE LIDOCAINE AMPULE WAS BROKEN AND THE NEEDLE DRIVER WAS "CONTAMINATED". A PHOTO PROVIDED BY THE CUSTOMER SHOWS A BROWN/ORANGE SUBSTANCE ON THE NEEDLE DRIVER. NO DEVICE FROM THE TRAY MADE PATIENT CONTACT. THE DEVICE HAD BEEN STORED IN A PYXIS. ANOTHER DEVICE OF THE SAME TYPE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13266451 ↗
• MalfunctionJan 11, 2021Packaging Problem; Packaging Problem

  NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11148407 ↗