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Palindrome 8888145063CPRecalls & reported problems

Mozarc Medical US LLC · Precision SI Chronic Catheter Kit,Symmetrical Tip, Silver Ion Sleeve and Tal VenaTrac Stylet,14.5 Fr/Ch (4.8 mm) x 23 cm · Class 2 · Implant

All models of Palindrome (133)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884521158344), received between Dec 6, 2017 and Dec 6, 2017 — classified as 1 injury.

The most frequently reported specific device problem is “Detachment Of 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

Device problems

  • Detachment Of Device Component1

Patient problems

  • Blood Loss1

Recent adverse event reports

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

  • InjuryDec 6, 2017Detachment Of Device Component; Detachment Of Device Component

    ACCORDING TO THE REPORTER, THERE WAS A VENOUS ALARM 30 MINUTES BEFORE THE END OF THE HEMODIALYSIS TREATMENT. THE DEVICE¿S ADAPTERS WERE STILL ATTACHED TO THE PALINDROME CONNECTORS AND THE BLOOD WAS FLOWING OUT OF THE VENOUS SIDE. THE PATIENT WAS DIZZY AND HAD LOST AN UNMEASURABLE AMOUNT OF BLOOD. THE DOCTOR WAS INFORMED, AND THE PATIENT HAD TO BE RESUSCITATED. AFTER RESUSCITATION MEASURES IN INTENSIVE CARE, THE PATIENT WAS STABLE. THE PATIENT IS ALIVE WITH CEREBRAL DAMAGE DUE TO BLOOD LOSS AND LACK OF OXYGEN.

    Patient problems: Blood Loss

    MAUDE report 7086767 ↗

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-1885-2025 · Apr 23, 2025 · Open, Classified
    Palindrome Precision 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-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-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-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-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-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-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.

Other Catheter, hemodialysis, implanted devices

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Sources and updates

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