Palindrome 8888133504PRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884521157910), received between May 11, 2020 and May 11, 2020 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Infusion or Flow Problem” (3 reports).

2 FDA recall records name this device's identifier, 2 still open.

47 other recalls cover devices cleared under the same FDA submission (K123196); 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. Apr 23, 2025Class IIOpen, Classified

   Potential breach of sterile barrier packaging.

   Z-1885-2025 · Root cause: Packaging · 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-1312-2022 · 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.

• MalfunctionMay 11, 2020Infusion or Flow Problem; Infusion or Flow Problem

  ACCORDING TO THE REPORTER, A 33 CENTIMETER WAS PLACED (INTRA-JUGULAR) ON A PATIENT WITH RENAL FAILURE. SEVERAL REPLACEMENTS OVER THE WIRE IN INTERVENTIONAL RADIOLOGY WERE REQUIRED (FROM THE SAME BRAND AND LOT NUMBER) AND ON THE FOURTH REPLACEMENT, A CATHETER FROM ANOTHER BRAND WAS USED FOR THE EXCHANGE. IT WAS MENTIONED THAT THESE SEVERAL CATHETERS DID NOT FUNCTION AND THEY COULD NOT GET THE CATHETERS TO WORK (DID NOT ALLOW SUFFICIENT BLOOD FLOW) AS EXPECTED DURING TREATMENT WHICH REQUIRED THE FREQUENT EXCHANGES TO OCCUR. THE DIALYSIS MACHINE ALSO HAD HIGH ALARMS INDICATING RESISTANCE TO BLOOD FLOWS WITH ALL THREE OF THE CATEHTERS. THERE CATHETER WAS NOT REPAIRED AND THERE WAS NO LEAK. THERE WAS NO LUER ADAPTER ISSUE AND CHLORHEXIDINE WAS USED AS A CLEANING AGENT ON THE DEVICE. TEGO WAS NOT UTILIZED AND THE INSERTION SITE WAS TREATMENT PRIOR TO PRODUCT PLACEMENT FOLLOWING HOSPITAL PROTOCOL. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE. FLUSHING WAS DONE AND NOTHING WAS UNUSUAL WITH THE RESULT. THERE WERE NO OTHER DEFECTS/DAMAGES FOUND ON THE PRODUCT. THERE WAS NO BLOOD LOSS AND BLOOD TRANSFUSION WAS NOT REQUIRED. THE EVENT DID NOT LEAD TO OR EXTEND PATIENT HOSPITALIZATIO

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10044713 ↗
• MalfunctionMay 11, 2020Infusion or Flow Problem; Infusion or Flow Problem

  ACCORDING TO THE REPORTER, A 33 CENTIMETER CATHETER WAS PLACED (INTRA-JUGULAR) ON A PATIENT WITH RENAL FAILURE. THIS IS THE SECOND C ASE/EVENT OF SEVERAL REPLACEMENTS OVER THE WIRE IN INTERVENTIONAL RADIOLOGY WERE REQUIRED (FROM THE SAME BRAND AND LOT NUMBER) AND ON THE FOURTH REPLACEMENT, A CATHETER FROM ANOTHER BRAND WAS USED FOR THE EXCHANGE. IT WAS MENTIONED THAT THESE SEVERAL CATHETERS DID NOT FUNCTION AND THEY COULD NOT GET THE CATHETERS TO WORK (DID NOT ALLOW SUFFICIENT BLOOD FLOW) AS EXPECTED DURING TREATMENT WHICH REQUIRED THE FREQUENT EXCHANGES TO OCCUR. THE DIALYSIS MACHINE ALSO HAD HIGH ALARMS INDICATING RESISTANCE TO BLOOD FLOWS WITH ALL THREE OF THE CATHETERS. THE CATHETER WAS NOT REPAIRED AND THERE WAS NO LEAK. THERE WAS NO LUER ADAPTER ISSUE AND CHLORHEXIDINE WAS USED AS A CLEANING AGENT ON THE DEVICE. TEGO WAS NOT UTILIZED AND THE INSERTION SITE WAS TREATED PRIOR TO PRODUCT PLACEMENT FOLLOWING HOSPITAL PROTOCOL. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE. FLUSHING WAS DONE AND NOTHING WAS UNUSUAL WITH THE RESULT. THERE WERE NO OTHER DEFECTS/DAMAGES FOUND ON THE PRODUCT. THERE WAS NO BLOOD LOSS AND BLOOD TRANSFUSION WAS NOT REQUIRED. THE EVENT DID NOT L

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10042887 ↗
• MalfunctionMay 11, 2020Infusion or Flow Problem; Infusion or Flow Problem

  ACCORDING TO THE REPORTER, A 33 CENTIMETER WAS PLACED (INTRA-JUGULAR) ON A PATIENT WITH RENAL FAILURE. THIS IS THE FIRST CASE/EVENT WHEREIN SEVERAL REPLACEMENTS OVER THE WIRE IN INTERVENTIONAL RADIOLOGY WERE REQUIRED (FROM THE SAME BRAND AND LOT NUMBER) AND ON THE FOURTH REPLACEMENT, A CATHETER FROM ANOTHER BRAND WAS USED FOR THE EXCHANGE. IT WAS MENTIONED THAT THESE SEVERAL CATHETERS DID NOT FUNCTION AND THEY COULD NOT GET THE CATHETERS TO WORK (DID NOT ALLOW SUFFICIENT BLOOD FLOW) AS EXPECTED DURING TREATMENT WHICH REQUIRED THE FREQUENT EXCHANGES TO OCCUR. THE DIALYSIS MACHINE ALSO HAD HIGH ALARMS INDICATING RESISTANCE TO BLOOD FLOWS WITH ALL THREE OF THE CATHETERS. THE CATHETER WAS NOT REPAIRED AND THERE WAS NO LEAK. THERE WAS NO LUER ADAPTER ISSUE AND CHLORHEXIDINE WAS USED AS A CLEANING AGENT ON THE DEVICE. TEGO WAS NOT UTILIZED AND THE INSERTION SITE WAS TREATMENT PRIOR TO PRODUCT PLACEMENT FOLLOWING HOSPITAL PROTOCOL. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE. FLUSHING WAS DONE AND NOTHING WAS UNUSUAL WITH THE RESULT. THERE WERE NO OTHER DEFECTS/DAMAGES FOUND ON THE PRODUCT. THERE WAS NO BLOOD LOSS AND BLOOD TRANSFUSION WAS NOT REQUIRED. THE EVENT DID NOT LEAD

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10042879 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K123196. One submission often covers many models, so check the product and lot details in each record.

• Z-1888-2025 · Apr 23, 2025 · Open, Classified
  Palindrome Precision H Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.
• Z-1889-2025 · Apr 23, 2025 · Open, Classified
  MAHURKAR Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.
• Z-1887-2025 · Apr 23, 2025 · Open, Classified
  Palindrome Precision SI Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.
• Z-1886-2025 · Apr 23, 2025 · Open, Classified
  Palindrome Precision HSI Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.
• Z-1634-2024 · Mar 15, 2024 · Open, Classified
  Palindrome Precision HSI Chronic Catheter Sport Pack 14.5 Fr/Ch (4.8mm) x 19 cm (Symmetrical Tip, Heparin Coating, Silver Ion Sleeve and Tal VenaTrac Stylet- Intended for acute a
• Z-1635-2024 · Mar 15, 2024 · Open, Classified
  Palindrome Precision H Chronic Catheter Kit 14.5 Fr/Ch (4.8mm) x 23 cm (Symmetrical Tip, Heparin Coating and Tal VenaTrac Stylet- Intended for acute and chronic hemodialysis, aph
• Z-1313-2022 · Jun 8, 2022 · Open, Classified
  Palindrome Precision H Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access for acute and chronic hemodialysis, apheresis, and infusion.
• Z-1314-2022 · Jun 8, 2022 · Open, Classified
  Palindrome Precision SI Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access for acute and chronic hemodialysis, apheresis, and infusion.
• Z-1315-2022 · Jun 8, 2022 · Open, Classified
  Palindrome Precision HSI Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and infusion.
• Z-2372-2021 · May 28, 2021 · Open, Classified
  Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 28 cm, Item Code 8888541028P
• Z-2374-2021 · May 28, 2021 · Open, Classified
  Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 44 cm, Item Code 8888541044P
• Z-2375-2021 · May 28, 2021 · Open, Classified
  Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 55 cm, Item Code 8888541055P
• Z-2373-2021 · May 28, 2021 · Open, Classified
  Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 33 cm, Item Code 8888541033P
• Z-2371-2021 · May 28, 2021 · Open, Classified
  Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 23 cm, Item Code 8888541023P
• Z-0331-2016 · Oct 14, 2015 · Terminated
  Palindrome Precision Chronic Catheter Kit Symmetrical Tip, Tal VenaTrac" Stylet 14.5 Fr/Ch (4.8mm) X 33 cm Item Number: 8888145042P The Palindrome chronic catheter is intended for

…and 32 more.