Palindrome 8888145057CRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884521083073), received between Jul 30, 2018 and Aug 7, 2020 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 7, 2020Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, THE CATHETER WAS EASILY INSERTED IN A URAEMIC FLUID OVER-LOADED PATIENT INTO THE RIGHT INTERNAL JUGULAR LINE WITHOUT COMPLICATION BY AN EXPERIENCED OPERATOR. ON COMPLETION OF THE PROCEDURE, THE DOCTOR NOTICED A LEAK/EXCESSIVE BLEEDING AND LEAKING OF THE SALINE FLUSH FROM THE BLUE LUMEN (DILATED VENOUS SITE, BUT THE EXACT LOCATION OF THE LEAK IN THE BLUE EXTENSION TUBE WAS NOT VISIBLE) DESPITE THE LUMEN LOCK BEING IN PLACED AND CLAMPED. IT WAS MENTIONED THAT THE BLOOD EVENTUALLY TRACKED DOWN THE VENOUS HUB EXTENSION AND THE LEAKING OCCURRED PAST THE EXIT PORT. THIS WAS CONFIRMED WITH REPEATED FLUSHED WHICH WAS SUGGESTIVE OF A FAULTY LOCKING SYSTEM OR HOLE IN THE BLUE LUMEN SYSTEM. THE CATHETER WAS NOT REPAIRED, AND NO CLEANING AGENT WAS USED ON THE DEVICE AS IT CAME IN A STERILE KIT. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. THE LINE WAS FLUSHED PRIOR TO USE WITH STERILE SALINE WITH OPEN CLAMPS AND THEN IT WAS LOCKED AND HAD NO ABNORMALITIES NOTED AT THAT TIME, ALTHOUGH DETAILED OBSERVATION W AS NOT UNDERTAKEN AT THIS POINT. THERE WERE NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE, AND THERE WERE NO OTHER DEFECTS/DAMAGES FOUND ON TH

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10378862 ↗
• MalfunctionMar 21, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING THE FLUSHING OF THE ARTERIAL LUMEN OF THE CENTRAL VENOUS CATHETER, THE RED ULTEM ADAPTOR HAD BROKEN OFF ABOVE THE LEVEL OF THE CLAMP. A SMALL PIECE OF THE CATHETER EXTENSION TUBING WAS STILL ATTACHED TO THE ADAPTOR. THE LINE WAS CLAMPED IMMEDIATELY AND THE END WAS ATTACHED. THE LINE WAS THEN FLUSHED AND LOCKED WITH HEPARIN. THE CATHETER EXTENSION HAS BEEN REPAIRED WITH THE REPAIR KIT AND THE CATHETER IS PRESENTLY FUNCTIONING WELL. THE CATHETER HAD NO PREVIOUS REPAIRS. THERE WAS NO BLOOD LOSS, BLOOD TRANSFUSION, OR PATIENT INJURY.

  Patient problems: No Information

  MAUDE report 8439877 ↗
• MalfunctionJul 30, 2018Material Discolored; Obstruction of Flow; Material Deformation; Material Deformation

  ACCORDING TO THE REPORTER, DURING USE, THE COLOR OF THE CATHETER HAS CHANGED AND BUBBLES WERE NOTICED. IT WAS STATED THAT THE CATHETER WORKS PROPERLY AND THE INTERVENTIONAL RADIOLOGIST DID NOT WANT TO REPLACE IT JUST BECAUSE THE BUBBLES WERE PRESENT. IT WAS ALSO STATED THAT THE PATIENT'S CATHETER INSERTION SITE WAS SLIGHTLY FLUSHED.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7733456 ↗

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-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-1318-2022 · Jun 8, 2022 · Open, Classified
  Palindrome SI Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and infusion.
• Z1856-2015 · Apr 23, 2015 · Terminated
  Palindrome SI Chronic Catheter Sport Pack 14.5 Fr x 28 cm Item Code:8888228458
• Z-1894-2015 · Apr 23, 2015 · Terminated
  Palindrome HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 33cm Item Code: 8888145050
• 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-1877-2015 · Apr 23, 2015 · Terminated
  Palindrome Precision SI Chronic Catheter Kit 14.5 Fr x 44cm Item Code: 8888146144CP
• 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-1878-2015 · Apr 23, 2015 · Terminated
  Palindrome Precision SI Chronic Catheter Kit 14.5 Fr x 55cm Item Code: 8888145066P
• 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-1868-2015 · Apr 23, 2015 · Terminated
  Palindrome Precision SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 19cm Item Code: 8888145062P
• Z-1883-2015 · Apr 23, 2015 · Terminated
  Palindrome SI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 28cm Item Code: 8888128458
• 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-1873-2015 · Apr 23, 2015 · Terminated
  Palindrome Precision SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 28cm Item Code: 8888145064CP
• Z-1893-2015 · Apr 23, 2015 · Terminated
  Palindrome HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 28cm Item Code:8888145049C
• Z-1861-2015 · Apr 23, 2015 · Terminated
  Palindrome SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 23cm Item Code: 8888145063C

…and 49 more.