Palindrome 8888119365Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884521012813), received between Aug 3, 2022 and Aug 3, 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.

64 other recalls cover devices cleared under the same FDA submission (K112477); 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-1317-2022 · 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.

• MalfunctionAug 3, 2022Insufficient Flow or Under Infusion; Defective Component; Insufficient Flow or Under Infusion; Defective Component

  ACCORDING TO THE REPORTER, THE PATIENT HAD A POORLY FUNCTIONING DIALYSIS CATHETER WHEREIN THE CATHETER HAD AN INSUFFICIENT FLOW AND LESS ADEQUATE HEMODIALYSIS - THE LINE DID NOT SUSTAIN THE PUMP SPEEDS REQUIRED FOR ADEQUATE HEMODIALYSIS. IT WAS SAID THAT IT WAS A FIRST TIME ISSUE. THE CATHETER WAS NOT REPAIRED. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO HEMODIALYSIS. NO VISIBLE DEFECTS/DAMAGES WERE FOUND ON THE PRODUCT. THERE WAS NO LEAK AND NO LUER ADAPTER ISSUE. TEGO WAS UTILIZED. SOLUPREP, A SOLUTION OF 2% W/V (WEIGHT PER VOLUME) CHLORHEXIDINE GLUCONATE (CHG) AND 70% V/V (VOLUME/VOLUME) ISOPROPYL ALCOHOL (IPA) WERE USED AS CLEANING AGENT ON THE DEVICE. TEGADERM DRESSING AND TRIPLE ANTIBIOTIC OINTMENT WERE BEING UTILIZED ON THE DEVICE. THERE WAS NO BLOOD LOSS AND NO BLOOD TRANSFUSION WAS REQUIRED. IT WAS SAID THAT FLUSHING OF THE LINE AND REVERSING OF THE LINE WHILE ON HEMODIALYSIS, CHANGING OF THE TEGOS, GIVING OF TPA (TISSUE PLASMINOGEN ACTIVATOR) TO TRY AND IMPROVE THE FLOW WERE DONE TO RESOLVE THE ISSUE (NO INVASIVE PROCEDURE WAS DONE). THE PATIENT BOOKED FOR REMOVAL AND REPLACEMENT OF THE CATHETER. EVENTUALLY, ON JUNE 28, THE CATHETER WAS EXPLANTED AND REPLACED WITH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15158805 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K112477. One submission often covers many models, so check the product and lot details in each record.

• Z-1319-2022 · Jun 8, 2022 · Open, Classified
  Palindrome HSI Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and infusion.
• Z-1318-2022 · Jun 8, 2022 · Open, Classified
  Palindrome SI Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and infusion.
• Z-1873-2015 · Apr 23, 2015 · Terminated
  Palindrome Precision SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 28cm Item Code: 8888145064CP
• Z-1882-2015 · Apr 23, 2015 · Terminated
  Palindrome SI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 28cm Item Code: 8888128458
• Z-1872-2015 · Apr 23, 2015 · Terminated
  Palindrome Precision SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 28cm Item Code: 8888145064P
• Z-1899-2015 · Apr 23, 2015 · Terminated
  Palindrome Precision HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 23cm Item Code: 8888145048CP
• Z-1886-2015 · Apr 23, 2015 · Terminated
  Palindrome Precision SI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 28cm Item Code: 8888128458P
• Z-1877-2015 · Apr 23, 2015 · Terminated
  Palindrome Precision SI Chronic Catheter Kit 14.5 Fr x 44cm Item Code: 8888146144CP
• Z-1904-2015 · Apr 23, 2015 · Terminated
  Palindrome HSI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 19cm Item Code: 8888119369
• Z-1875-2015 · Apr 23, 2015 · Terminated
  Palindrome Precision SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 33cmItem Code: 8888145065CP
• Z-1881-2015 · Apr 23, 2015 · Terminated
  Palindrome SI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 23cm Item Code: 8888123408
• Z-1878-2015 · Apr 23, 2015 · Terminated
  Palindrome Precision SI Chronic Catheter Kit 14.5 Fr x 55cm Item Code: 8888145066P
• Z-1874-2015 · Apr 23, 2015 · Terminated
  Palindrome Precision SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 33cm Item Code: 8888145065P
• Z-1862-2015 · Apr 23, 2015 · Terminated
  Palindrome SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 28cm Item Code:8888145064
• Z-1891-2015 · Apr 23, 2015 · Terminated
  Palindrome HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 23cm Item Code: 8888145048C

…and 49 more.