Palindrome 8888145045CPRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521158108), received between Mar 17, 2021 and Aug 23, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

48 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. 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-1313-2022 · 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.

• MalfunctionAug 23, 2022Break; Break

  ACCORDING TO THE REPORTER, BEFORE DIALYSIS DURING TEGO CHANGE, IT WAS NOTED THAT THE CATHETER HAD CRACKED AT THE LUER ADAPTER CONNECTOR (BOTH VENOUS: BLUE, ARTERIAL: RED). IT WAS STATED THAT THE CATHETER HAS BEEN IN PLACE FOR SEVEN MONTHS. THERE WAS NO LEAK, THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE BEFORE USE, THE DEVICE WAS FLUSHED PRIOR TO USE AND EVERYTHING WENT NORMALLY. THE CLEANING AGENT USED ON THE DEVICE IS OCTENISEPT, OCTENISEPT WAS ALSO THE CLEANING AGENT TYPICALLY USED TO CLEAN THE ADAPTERS, AND THE CLEANING AGENT EXPOSURE TIME WAS ONE MINUTE (WHETHER IT ALWAYS DRIED IN ANY CASE WAS UNKNOWN) BEFORE APPLYING THE OINTMENT TO THE AREA. THE METHOD USED TO TIGHTEN THE ADAPTERS WAS HAND-HELD, NO OTHER PRODUCT WAS USED ON THE DEVICE, NO EXCESSIVE FORCE WAS USED ON THE DEVICE, AND THE CATHETER CANNOT BE REPAIRED BECAUSE THERE WAS NO REPAIR KIT AVAILABLE. IT WAS STATED THAT THE CORRECTIVE ACTION WAS POWERED BY TEGO (TEGO WAS UTILIZED) AND THE PROCEDURE WAS CONTINUED AND COMPLETED AFTER THE CORRECTIVE ACTION WAS DONE. INTERVENTION/TREATMENT WAS NOT REQUIRED DUE TO ADAPTER ISSUE. THERE WAS NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. THERE WAS NO BLOOD L

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15278838 ↗
• MalfunctionMar 17, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, ON FLUSHING AT THE END OF A TREATMENT, THE LINE FELL APART FROM THE TRIANGLE PLASTIC THAT HAD THE HOLES FOR ANCHORING STITCHES. IT SNAPPED ON THE ARTERIAL LUMEN SIDE. THE CATHETER WAS NOT REPAIRED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11504990 ↗

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-1887-2025 · Apr 23, 2025 · Open, Classified
  Palindrome Precision SI 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-1886-2025 · Apr 23, 2025 · Open, Classified
  Palindrome Precision HSI 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-1889-2025 · Apr 23, 2025 · Open, Classified
  MAHURKAR Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.
• 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-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-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-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-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-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-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
• 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

…and 33 more.