Palindrome 8888145045CRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521056329), received between Jul 29, 2021 and Jul 3, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 3, 2023Migration; Migration

  ACCORDING TO THE REPORTER, THE UNIT STAFF WAS ABOUT TO COMMENCE DIALYSIS. THEY NOTICED THAT THE PATIENT'S DRESSING WAS SOAKED WITH BLOOD AND COVERED HEAVILY WITH GAUZE WHICH HAD BEEN PLACED BY THE PATIENT ON TOP OF THE EXIT SITE TO STOP THE BLEEDING. AS SOON AS THE TAPE HAD BEEN REMOVED THEY NOTICED THAT THE LINE CUFF WAS OUT AND THE ENTIRE LINE LOOKED A LOT LONGER THAN IT USED TO BE. THE PATIENT SAID THAT THEY DID NOT DO ANYTHING ASIDE FROM PUTTING GAUZE ON TOP OF THE DRESSING. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17250191 ↗
• MalfunctionJul 29, 2021Material Frayed; Product Quality Problem; Difficult to Remove; Material Frayed; Product Quality Problem; Difficult to Remove

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE FOR THE REMOVAL OF TEMPORARY CENTRAL VENOUS CATHETER (CVC) ON A GUIDE WIRE AND MOVE TO THE INSERTION OF THE ANTEROGRADE CATHETER WITH THE STYLETS, THE STYLETS WERE WASHED WITH SALINE ALONG WITH THE CATHETER RESPECTING ALL THE STEPS NECESSARY FOR THE SUCCESS OF THE PROCEDURE. ONCE THE CATHETER WAS POSITIONED AND THE SCOPE CHECKED THAT THE TIP WAS WELL POSITIONED, THE GUIDE WIRE AND STYLETS WERE REMOVED. EVERYTHING WAS VERY DIFFICULT SO THE WHOLE CATHETER WAS FORCED TO BE REMOVED BECAUSE THEY COULD NOT REMOVE THE STYLETS SINCE IT WAS INSIDE THE CATHETER. NO EXCESSIVE FORCE WAS USED AT THE BEGINNING, THEN A LITTLE MORE BUT THEY STOPPED. THE DEVICE WAS NOT USED SUCCESSFULLY. IT WAS NOTICED THAT THE GUIDE WIRE WAS COILED WHEN IT WAS REMOVED AND ALL THE PIECES ARE ACCOUNTED FOR. THE CUSTOMER LEFT THE PATIENT WITHOUT VASCULAR ACCESS AND THE PROCEDURE WAS NOT COMPLETED. THEY HAVE TO RESCHEDULE ANOTHER IMPLANT AND USE ANOTHER DEVICE. THE STYLETS DID NOT BREAK INTO PARTS. NO IMAGING WAS REQUIRED FOR PIECE RETRIEVAL. FLUSHING WAS DONE AND ALL WAS GOOD. THERE WAS NO OTHER INTERVENTION OR TREATMENT REQUIRED. THE GUIDEWIRE AND THE STYLETS ARE THE O

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12245573 ↗

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-1885-2015 · Apr 23, 2015 · Terminated
  Palindrome Precision SI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 23cm Item Code: 8888123408P
• Z-1906-2015 · Apr 23, 2015 · Terminated
  Palindrome HSI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 28cm Item Code: 8888128459
• 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-1905-2015 · Apr 23, 2015 · Terminated
  Palindrome HSI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 23cm Item Code: 8888123409
• Z-1910-2015 · Apr 23, 2015 · Terminated
  Palindrome Precision HSI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 28cm Item Code: 8888128459P
• Z-1908-2015 · Apr 23, 2015 · Terminated
  Palindrome Precision HSI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 19cm Item Code: 8888119369P
• Z-1851-2015 · Apr 23, 2015 · Terminated
  Palindrome SI Chronic Catheter Kit 14.5 Fr x 23cm Item Code: 8888245063
• Z-1891-2015 · Apr 23, 2015 · Terminated
  Palindrome HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 23cm Item Code: 8888145048C
• 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-1873-2015 · Apr 23, 2015 · Terminated
  Palindrome Precision SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 28cm Item Code: 8888145064CP
• Z-1853-2015 · Apr 23, 2015 · Terminated
  Palindrome SI Chronic Catheter Kit 14.5 Fr x 28cm Item Code: 8888245064
• Z-1871-2015 · Apr 23, 2015 · Terminated
  Palindrome Precision SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 23cm Item Code: 8888145063CP
• Z-1902-2015 · Apr 23, 2015 · Terminated
  Palindrome Precision HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 33cm Item Code: 8888145050P

…and 49 more.