Palindrome 8888145042Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884521056688), received between Jul 6, 2022 and Jul 6, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Defective Component” (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.

• MalfunctionJul 6, 2022Defective Component; Obstruction of Flow; Defective Component; Obstruction of Flow

  ACCORDING TO THE REPORTER, WHEN THE PROCEDURE WAS STARTED AND THE CATHETER OF 14.5 FR (4.8MM) X 33 CM (CENTIMETER) WAS INSERTED INSIDE TO THE VENA CAVA, THE CATHETER TIP WAS TWISTED. THE DOCTOR TRIED TO STRAIGHTEN THE TIP WITH AMPLATZER STIFF GUIDES FOR TWO HOURS, BUT IT REMAINS IMPOSSIBLE. THE CATHETER HAD TO BE REMOVED FOLDED AND A CATHETER WAS PLACED. THE CATHETER WAS NOT REPAIRED, THERE WAS NO LEAK, AND THERE WAS NO LUER ADAPTER ISSUE. THERE WAS NO MEDICAL OR SURGICAL INTERVENTION NEEDED TO PREVENT A PERMANENT IMPAIRMENT OF A FUNCTION AND THE EVENT DID NOT LEAD TO OR EXTEND PATIENT HOSPITALIZATION. THE PROCEDURE WAS COMPLETED, THERE WAS NO BLOOD LOSS AND BLOOD TRANSFUSION WAS NOT REQUIRED. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE, FLUSHING WAS PERFORMED PRIOR TO USE WITH HEPARINIZED SALINE SOLUTION WITH NO PROBLEM RESULT AND THERE WAS NO OTHER PRODUCT UTILIZED WITH THE DEVICE. THERE WERE NO OTHER DEFECTS/DAMAGES FOUND ON THE PRODUCT, HEPARINIZED SALINE SOLUTION WAS USED AS THE CLEANING AGENT ON THE DEVICE, AND THE PATIENT WAS TREATED UNDER LOCAL ANESTHESIA. IT WAS ALSO STATED THAT THE SURGERY PROCEDURE OR STEPS WAS THE RIGHT FEMORAL PERMANENT HEMODIALYSIS CATHETE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14938717 ↗

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.