Palindrome 8888541033PRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884521158528), received between May 25, 2021 and May 25, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

49 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.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 25, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRIOR TO HEMODIALYSIS TREATMENT, THE CATHETER DISLODGED BETWEEN THE SHAFT AND CONNECTOR/BIFURCATE. THE NURSE FOUND OUT THE DISLODGE WHEN THE PATIENT WAS READY TO DO HEMODIALYSIS. THE HUB AND ASSEMBLY WERE REPLACED AS AN INTERVENTION TO RESOLVE THE ISSUE. IT WAS STATED THAT THE DEVICE WAS USED SUCCESSFULLY AND THE TREATMENT WAS COMPLETED. THERE WAS NO BLOOD LOSS AND NO BLOOD TRANSFUSION REQUIRED. THERE WAS NO LEAK, NO TEGO UTILIZED, AND NO LUER ADAPTER ISSUE. THE CATHETER WAS NOT INTENTIONALLY OR ACCIDENTALLY REMOVED BY THE PATIENT. THERE WAS NO DEFECT/DAMAGE ON THE REPLACEABLE BIFURCATE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11880352 ↗

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-1889-2025 · Apr 23, 2025 · Open, Classified
  MAHURKAR 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-1885-2025 · Apr 23, 2025 · Open, Classified
  Palindrome Precision Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.
• Z-1888-2025 · Apr 23, 2025 · Open, Classified
  Palindrome Precision H 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-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-1312-2022 · Jun 8, 2022 · Open, Classified
  Palindrome Precision 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-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-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-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-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

…and 34 more.