Cook G02364Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00827002023642), received between Jul 24, 2018 and Jul 13, 2021 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Corroded” (3 reports).

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

1. Oct 8, 2021Terminated

   Transseptal needles may contain rust on the interior and/or exterior of the needle, which may not be detected by the user. Potential adverse events if an affected product is used ranges from increased procedural time to inflammatory reactions, which at their most severe include systemic reactions potentially leading to permanent impairment or death.

   Z-0222-2022 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

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.

• MalfunctionJul 13, 2021Corroded; Device Contaminated During Manufacture or Shipping; Corroded; Device Contaminated During Manufacture or Shipping

  THERE IS NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12162654 ↗
• MalfunctionJul 13, 2021Corroded; Device Contaminated During Manufacture or Shipping; Corroded; Device Contaminated During Manufacture or Shipping

  THERE IS NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12160208 ↗
• MalfunctionMay 18, 2021Corroded; Device Contamination with Chemical or Other Material; Corroded; Device Contamination with Chemical or Other Material

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11844972 ↗
• MalfunctionAug 26, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem

  AS REPORTED, PRIOR TO PATIENT CONTACT DURING A CARDIAC ABLATION PROCEDURE, AN UNKNOWN ORANGE FLUID AND PARTICULATE CAME OUT OF A TRANSSEPTAL NEEDLE UPON FLUSHING THE DEVICE. THE DEVICE DID NOT MAKE PATIENT CONTACT. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE HAS BEEN NO REPORT THAT THE PATIENT REQUIRED ANY ADDITIONAL PROCEDURES OR EXPERIENCED ANY ADVERSE EFFECTS DUE TO THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10453357 ↗
• MalfunctionJul 24, 2018Defective Device; Defective Device

  IT WAS REPORTED, TWO TRANSSEPTAL NEEDLES FROM THE SAME LOT WERE FOUND TO HAVE NO "BACK BEVEL" AND WERE SCORING THE INSIDE OF THE SHEATH WHEN INSERTED. SUBSEQUENTLY, THEY WERE NOT USED DURING A PATIENT PROCEDURE. ADDITIONAL TRANSSEPTAL NEEDLES WERE FOUND TO BE FREE FROM THESE ISSUES AND WERE ABLE TO BE USED SUCCESSFULLY WITHOUT ISSUE. PER THE COMPLAINANT, NO ADVERSE EFFECTS WERE REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 7714134 ↗