Palindrome 8888123405PRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521157781), received between Jun 8, 2018 and Aug 22, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Failure To Adhere Or Bond” (1 report).

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-1888-2025 · 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-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 22, 2022Migration; Migration

  ACCORDING TO THE REPORTER, THE WRITER DID A CHECK ON PATIENT AND NOTICED THAT THERE WAS A BIT OF BLOOD ON PATIENT¿S SHIRT THAT WAS NOT REMEMBERED BEING THERE. WRITER THEN ATTEMPTED TO CHECK THE CVC (CENTRAL VENOUS CATHETER) AND NOTICED THAT IT HAS MIGRATED (SITE TO HUB MEASURED 4CM). THE PUMP STOPPED AND THE ACCESS NURSE WAS MADE AWARE. AS PER ACCESS NURSE, MAY RETURN BLOOD. BLOOD WAS RETURNED, ENDED THE ULTRA-FILTRATION AND RINSED BACK. THERE WAS NO INVASIVE PROCEDURE DONE. ACCESS NURSE WILL ARRANGE FOR LINE EXCHANGE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15269918 ↗
• 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 REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7583080 ↗

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-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-1887-2025 · Apr 23, 2025 · Open, Classified
  Palindrome Precision SI 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-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-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-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-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-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-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-0330-2016 · Oct 14, 2015 · Terminated
  Palindrome Precision Chronic Catheter Kit Symmetrical Tip 14.5 Fr/Ch (4.8mm) X 33 cm Item Number: 8888145017P The Palindrome chronic catheter is intended for acute and chronic he

…and 32 more.