Palindrome 8888145049Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521017818), received between Feb 27, 2020 and Mar 31, 2021 — classified as 2 malfunctions.

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

• MalfunctionMar 31, 2021Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, THE RED/ARTERIAL EXTENSION TUBE HAD A LEAK AT THE JUNCTION OF THE EXTENSION TUBE AND BIFURCATE AND HAD A CRACK. THE CATHETER WAS NOT REPAIRED AND TEGO WAS NOT UTILIZED. NO INSTRUMENT WAS USED TO LOOSEN OR TIGHTEN THE DEVICE AND THERE WAS NO CRACK IN THE LUER ADAPTER. CHLORHEXIDINE 2% WAS USED AS THE CLEANING AGENT ON THE DEVICE AND THERE WAS NO SOLUTION USED ON THE INSERTION SITE PRIOR TO PRODUCT PLACEMENT. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE AND THERE WERE NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. THE CLAMP WAS NOT MOVED PERIODICALLY (JUST FOR ONE HEMODIALYSIS TREATMENT). THERE WAS BLOOD LOSS (MINIMUM LOSS) AND 2 GAUZES WERE CHANGED. BLOOD TRANSFUSION WAS NOT REQUIRED AND THERE WAS NO INTERVENTION OR TREATMENT REQUIRED AS A RESULT OF THE LEAKAGE. THERE WAS NO MEDICAL OR SURGICAL INTERVENTION NEEDED TO PREVENT A PERMANENT IMPAIRMENT OF A FUNCTION AND THE EVENT DID NOT LEAD TO OR EXTEND PATIENT HOSPITALIZATION. THE CATHETER WAS REMOVED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11595863 ↗
• MalfunctionFeb 27, 2020Material Fragmentation; Material Fragmentation

  ACCORDING TO THE REPORTER, THE PATIENT WAS HAVING A REPLACEMENT OF THE LEFT JUGULAR TUNNELED CATHETER OVER A WIRE. INTRA-OPERATIVELY, THE SHEATH BROKE WHEN THE SURGEON WAS EXCHANGING THE BLUE SHEATH THAT GOES INTO THE CENTER OF THE LUMEN IN A PATIENT WITH END-STAGE RENAL DISEASE WITH DYSFUNCTIONAL LEFT JUGULAR TUNNELED CATHETER. WHEN THE SURGEON ATTEMPTED TO REMOVE THE SHEATH, ALL PIECES WERE REMOVED AND ACCOUNTED FOR. AFTER A THIRD ATTEMPT, A NEW CATHETER WAS INSERTED WITHOUT INCIDENT. POST-OPERATIVE CHEST X-RAY WAS DONE WHICH SHOWED DIALYSIS CATHETER TIP PROJECTS OVER THE JUNCTION OF SUPERIOR VENA CAVA AND RIGHT ATRIUM. THERE WAS NO PNEUMOTHORAX.

  Patient problems: Foreign Body In Patient

  MAUDE report 9763729 ↗

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.
• 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-1865-2015 · Apr 23, 2015 · Terminated
  Palindrome SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 33cm Item Code: 8888145065C
• 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-1878-2015 · Apr 23, 2015 · Terminated
  Palindrome Precision SI Chronic Catheter Kit 14.5 Fr x 55cm Item Code: 8888145066P
• Z-1863-2015 · Apr 23, 2015 · Terminated
  Palindrome SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 28cm Item Code: 8888145064C
• Z-1877-2015 · Apr 23, 2015 · Terminated
  Palindrome Precision SI Chronic Catheter Kit 14.5 Fr x 44cm Item Code: 8888146144CP
• Z-1900-2015 · Apr 23, 2015 · Terminated
  Palindrome Precision HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 28cm Item Code: 8888145049P
• Z-1872-2015 · Apr 23, 2015 · Terminated
  Palindrome Precision SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 28cm Item Code: 8888145064P
• 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-1852-2015 · Apr 23, 2015 · Terminated
  Palindrome SI Chronic Catheter Kit 14.5 Fr x 28cm Item Code: 8888245064
• Z-1854-2015 · Apr 23, 2015 · Terminated
  Palindrome SI Chronic Catheter Kit 14.5 Fr x 28cm Item Code: 8888245064
• Z-1858-2015 · Apr 23, 2015 · Terminated
  Palindrome SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 19cm Item Code: 8888145062
• 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

…and 49 more.