Palindrome 8888145045Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884521017900), received between Jun 8, 2018 and Mar 13, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (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 16, 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 13, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING NORMAL USE, IT WAS FOUND THAT THERE WAS A CRACK ON THE BLUE (VENOUS) INTRAVENOUS ADAPTER. IT WAS ALSO STATED THAT THERE WAS A LEAK AT THE LUER ADAPTER. THE CATHETER WAS NOT REPAIRED, TEGO WAS NOT UTILIZED. THERE WAS NO INSTRUMENT USED TO LOOSEN OR TIGHTEN THE DEVICE. THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21593783 ↗
• MalfunctionJan 28, 2025Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, THE PRODUCT WAS RINSED BEFORE USE, AND THE CATHETER EXTENSION TUBE WAS FOUND TO HAVE TRACHOMA AND LIQUID LEAKAGE AT THE VENOUS END NEAR BIFURCATE. THERE WAS AN UNUSUAL OBSERVATION ON THE DEVICE PRIOR TO USE. FLUSHING WAS DONE, AND THERE WAS A LEAKING LIQUID. THERE WAS NO EXCESSIVE FORCE USED ON THE DEVICE.  THERE WAS NO CLEANING AGENT USED ON THE DEVICE. THE TEGO WAS NOT UTILIZED. THERE WAS NO LUER ADAPTER ISSUE. THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. THE CATHETER WAS NOT REPAIRED. BESIDES THE REPORTED ISSUE, THERE WERE NO OTHER VISIBLE DEFECTS/DAMAGES FOUND ON THE PRODUCT AT THE TIME OF THE EVENT. THE REPORTED PRODUCT WAS REPLACED. THERE WAS NO REMEDIAL ACTION PERFORMED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21252012 ↗
• MalfunctionJun 8, 2018Failure To Adhere Or Bond; Failure To Adhere Or Bond

  ACCORDING TO THE REPORTER, THE CATHETER FELL OUT. IT WAS STATED THAT THE TISSUE ATTENUATION INTO THE CUFF SEEMED TO BE DELAYED OR ABSENT. THE CATHETER WAS SECURED WITH SUTURES FOR AN EXTENDED PERIOD OF TIME BUT IN THIS SITUATION, IT WAS STATED THAT THE CUFF WAS CLEARLY EXPOSED. THE CATHETER WAS INSERTED AND WAS REMOVED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7582727 ↗

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-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-1881-2015 · Apr 23, 2015 · Terminated
  Palindrome SI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 23cm Item Code: 8888123408
• 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-1868-2015 · Apr 23, 2015 · Terminated
  Palindrome Precision SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 19cm Item Code: 8888145062P
• Z-1857-2015 · Apr 23, 2015 · Terminated
  Palindrome SI Chronic Catheter Sport Pack 14.5 Fr x 33 cm Item Code: 8888233508
• Z-1875-2015 · Apr 23, 2015 · Terminated
  Palindrome Precision SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 33cmItem Code: 8888145065CP
• Z-1911-2015 · Apr 23, 2015 · Terminated
  Palindrome Precision HSI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 33cm Item Code: 8888133509P
• Z-1860-2015 · Apr 23, 2015 · Terminated
  Palindrome SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 23cm Item Code: 8888145063
• Z-1897-2015 · Apr 23, 2015 · Terminated
  Palindrome Precision HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 19cm Item Code: 8888145057CP
• Z-1898-2015 · Apr 23, 2015 · Terminated
  Palindrome Precision HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 23cm Item Code: 8888145048P
• 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-1870-2015 · Apr 23, 2015 · Terminated
  Palindrome Precision SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 23cm Item Code: 8888145063P
• Z-1902-2015 · Apr 23, 2015 · Terminated
  Palindrome Precision HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 33cm Item Code: 8888145050P
• Z-1852-2015 · Apr 23, 2015 · Terminated
  Palindrome SI Chronic Catheter Kit 14.5 Fr x 28cm Item Code: 8888245064

…and 49 more.