Palindrome 8888128458Recalls & reported problems

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

2 FDA recall records name this device's identifier, 2 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-1314-2022 · Root cause: Process control · Recall details · FDA record ↗

2. 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-1318-2022 · Root cause: Process control · Recall details · FDA record ↗

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-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-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-1901-2015 · Apr 23, 2015 · Terminated
  Palindrome Precision HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 28cm Item Code: 8888145049CP
• Z-1891-2015 · Apr 23, 2015 · Terminated
  Palindrome HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 23cm Item Code: 8888145048C
• Z-1876-2015 · Apr 23, 2015 · Terminated
  Palindrome Precision SI Chronic Catheter Kit 14.5 Fr x 44cm Item Code: 8888146144P
• Z-1850-2015 · Apr 23, 2015 · Terminated
  Palindrome SI Chronic Catheter Kit 14.5 Fr x 19cm Item Code: 8888245062 The Palindrome SI Chronic Catheter is indicated for acute and chronic hemodialysis, apheresis, and infusion.
• Z-1851-2015 · Apr 23, 2015 · Terminated
  Palindrome SI Chronic Catheter Kit 14.5 Fr x 23cm Item Code: 8888245063
• Z-1907-2015 · Apr 23, 2015 · Terminated
  Palindrome HSI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 33cm Item Code: 8888133509
• 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-1899-2015 · Apr 23, 2015 · Terminated
  Palindrome Precision HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 23cm Item Code: 8888145048CP
• 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-1852-2015 · Apr 23, 2015 · Terminated
  Palindrome SI Chronic Catheter Kit 14.5 Fr x 28cm Item Code: 8888245064
• Z-1862-2015 · Apr 23, 2015 · Terminated
  Palindrome SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 28cm Item Code:8888145064
• Z-1873-2015 · Apr 23, 2015 · Terminated
  Palindrome Precision SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 28cm Item Code: 8888145064CP

…and 49 more.