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Palindrome 8888145064PRecalls & 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 28 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
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884521158375), received between Jun 8, 2018 and Jun 8, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Failure To Adhere Or Bond” (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

  • Failure To Adhere Or Bond1

Patient problems

  • No Consequences Or Impact To Patient1

Recent adverse event reports

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

  • MalfunctionJun 8, 2018Failure To Adhere Or Bond; Failure To Adhere Or Bond

    ACCORDING TO THE REPORTER, THE CATHETER FELL OUT. IT WAS STATED THAT THE TISSUE ATTENUATION INTO THE CUFF SEEMED TO BE DELAYED OR ABSENT. THE CATHETER WAS SECURED WITH SUTURES FOR AN EXTENDED PERIOD OF TIME BUT IN THIS SITUATION, IT WAS STATED THAT THE CUFF WAS CLEARLY EXPOSED. THE CATHETER WAS INSERTED AND WAS REMOVED. THERE WAS NO PATIENT INJURY.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7582911 ↗

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-1889-2025 · Apr 23, 2025 · Open, Classified
    MAHURKAR 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-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-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-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-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-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

…and 34 more.

Other Catheter, hemodialysis, implanted devices

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Sources and updates

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