Palindrome 8888145060Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884521013360), received between Mar 28, 2024 and Mar 28, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Puncture/Hole” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

2 other recalls cover devices cleared under the same FDA submission (K111372); they may or may not involve this specific model.

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.

Recalls naming this device

1. Jun 8, 2022Class IOpen, Classified

   There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an inter-lumen void in the hub component, which may result in unanticipated fluid return during use.

   Z-1316-2022 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 28, 2024Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, THEY WENT TO PLACE AN EXTENDER ON THE PATIENT'S DIALYSIS CATHETER BECAUSE IT WAS DIFFICULT TO PUNCTURE ON THE CT (COMPUTED TOMOGRAPHY). THEY CAME BACK 10 MINUTES LATER, AT THE THEORETICAL END OF THE CT SCAN, TO DO THE DRESSING. THE X-RAY OPERATOR TOLD THEM THAT THE CATHETER FARTED AT THE VERY BEGINNING OF THE INJECTION. THEY NOTICED THAT THE VENOUS BRANCH OF THE CATHETER WAS CUT IN HALF. THEY CLAMPED THE BRANCH AND CALLED THE NEPHROLOGIST. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 19000823 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K111372. One submission often covers many models, so check the product and lot details in each record.

• Z-2632-2023 · Aug 22, 2023 · Open, Classified
  Palindrome Chronic Catheter Kit Symmetrical Tip14.5 Fr/Ch(4.8mm)x23cm
• Z-1320-2022 · Jun 8, 2022 · Open, Classified
  Mahurkar Chronic Carbothane (Maxid) Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and infusion.