Palindrome 8888123409Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884521012967), received between May 16, 2021 and May 16, 2021 — 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-1319-2022 · 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.

• MalfunctionMay 16, 2021Defective Component; Infusion or Flow Problem; Defective Component; Infusion or Flow Problem

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THE CATHETERS' LUMENS WERE TOO NARROW FOR STYLETS TO BE PASSED. THE CATHETERS WERE NOT REPAIRED AND THERE WAS NO LEAK. THERE WAS NO CLEANING AGENT USED ON THE DEVICES. TEGO WAS NOT UTILIZED AND THERE WAS NO LUER ADAPTER ISSUE. THERE WAS NO DAMAGE TO THE DEVICES' BOX AND PACKAGING. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICES PRIOR TO USE AND FLUSHING WAS DONE AND HAD NO ISSUES IN LUMEN WITH SALINE. THERE WERE NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICES AND NO OTHER DEFECTS/DAMAGES FOUND ON THE PRODUCTS. THE DIMENSIONS OF THE CATHETERS MATCHED WHAT WAS INDICATED ON THE LABELS AND THE STYLET USED WAS THE ONE INCLUDED IN EACH KITS. THE CATHETER WAS STILL USED, BUT THEY HAD TO USE A STIFFENING GUIDE WIRE INSTEAD OF THE STYLETS TO INSERT THE CATHETER AND THE PROCEDURE WAS COMPLETED. THE PHYSICIAN WAS ALSO AWARE THAT IF THE LUMEN WAS TOO NARROW FOR THE STYLET, THE VOLUME OF BLOOD FLOW RATES WOULD BE DECREASED. THIS EVENTUALLY RESULTED IN CATHETER FAILURE AND NEEDED A NEW CATHETER TO BE INSERTED ALTOGETHER AT A LATER DATE (WITHIN 6 WEEKS). THEY DECIDED TO PULL EVERY CATHETER THEY BELIEVED WERE AFFECTED BY THE MANUFACTURING ISSUE OFF T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11830139 ↗

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-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-1317-2022 · Jun 8, 2022 · Open, Classified
  Palindrome H Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and infusion.
• Z-1894-2015 · Apr 23, 2015 · Terminated
  Palindrome HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 33cm Item Code: 8888145050
• Z-1875-2015 · Apr 23, 2015 · Terminated
  Palindrome Precision SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 33cmItem Code: 8888145065CP
• Z-1857-2015 · Apr 23, 2015 · Terminated
  Palindrome SI Chronic Catheter Sport Pack 14.5 Fr x 33 cm Item Code: 8888233508
• Z-1851-2015 · Apr 23, 2015 · Terminated
  Palindrome SI Chronic Catheter Kit 14.5 Fr x 23cm Item Code: 8888245063
• Z-1871-2015 · Apr 23, 2015 · Terminated
  Palindrome Precision SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 23cm Item Code: 8888145063CP
• Z1856-2015 · Apr 23, 2015 · Terminated
  Palindrome SI Chronic Catheter Sport Pack 14.5 Fr x 28 cm Item Code:8888228458
• Z-1888-2015 · Apr 23, 2015 · Terminated
  Palindrome Precision SI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 33cm Item Code: 8888133508P
• Z-1879-2015 · Apr 23, 2015 · Terminated
  Palindrome Precision SI Chronic Catheter Kit 14.5 Fr x 55cm Item Code: 8888145066CP
• Z-1869-2015 · Apr 23, 2015 · Terminated
  Palindrome Precision SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 19cm Item Code: 8888145062CP
• Z-1864-2015 · Apr 23, 2015 · Terminated
  Palindrome SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 33cm Item Code: 8888145065
• Z-1854-2015 · Apr 23, 2015 · Terminated
  Palindrome SI Chronic Catheter Kit 14.5 Fr x 28cm Item Code: 8888245064
• Z-1891-2015 · Apr 23, 2015 · Terminated
  Palindrome HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 23cm Item Code: 8888145048C
• Z-1874-2015 · Apr 23, 2015 · Terminated
  Palindrome Precision SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 33cm Item Code: 8888145065P

…and 49 more.