Palindrome 8888541055Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884521135529), received between Jan 12, 2023 and Jan 12, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Markings/Labelling Problem” (1 report).

13 other recalls cover devices cleared under the same FDA submission (K111817); 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 16, 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.

• MalfunctionJan 12, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem

  ACCORDING TO THE REPORTER, THE PRODUCT WAS EXPIRED AT THE TIME OF IMPLANTATION. THE PRODUCT DID NOT REFLECT ON CONSIGNMENT AND WAS NOT ON ANY EXPIRED OR SHORT DATED STOCK REPORTS. THE CUSTOMER INFORMED THE SALES REPRESENTATIVE THAT THEY DID NOT KEEP THIS ITEM IN THEIR THEATRES IN (B)(6) 2022. THE SALES REPRESENTATIVE WAS ONLY MADE AWARE OF THIS INCIDENT WHEN THE CUSTOMER SENT AN ORDER, AND THEY ESTABLISHED THE PRODUCT WAS EXPIRED BUT IT DID NOT APPEAR ON THE SYSTEM. THE DEVICE WAS IMPLANTED, AND THE DOCTOR (SURGEON) INFORMED THE SALES REPRESENTATIVE THAT THEY ALREADY PLANNED TO REMOVE THE DEVICE IN +/- 2 WEEKS. THE CATHETER WAS NOT REPAIRED, THERE WAS NOLEAK, TEGO WAS NOT UTILIZED, THERE WAS NO LUER ADAPTER ISSUE AND THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. THERE WAS NO PATIENT SYMPTOMS OR COMPLICATION ASSOCIATED WITH THIS EVENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16154598 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K111817. One submission often covers many models, so check the product and lot details in each record.

• Z-2358-2021 · May 28, 2021 · Open, Classified
  Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 19 cm, Item Code 8888541019
• Z-2361-2021 · May 28, 2021 · Open, Classified
  Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 33cm, Item Code 8888541033
• Z-2370-2021 · May 28, 2021 · Open, Classified
  Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 19 cm, Item Code 8888541019P
• Z-2369-2021 · May 28, 2021 · Open, Classified
  Palindrome RT Repair Kit 15 FR TAL 55cm, Sterile, Item Code 8888541155
• Z-2365-2021 · May 28, 2021 · Open, Classified
  Palindrome RT Repair Kit 15 FR TAL 23cm, Sterile, Item Code 8888541123
• Z-2368-2021 · May 28, 2021 · Open, Classified
  Palindrome RT Repair Kit 15 FR TAL 44cm, Sterile, Item Code 8888541144
• Z-2367-2021 · May 28, 2021 · Open, Classified
  Palindrome RT Repair Kit 15 FR TAL 33cm, Sterile, Item Code 8888541133
• Z-2364-2021 · May 28, 2021 · Open, Classified
  Palindrome RT Repair Kit 15 FR TAL 19cm, Sterile, Item Code 8888541119
• Z-2366-2021 · May 28, 2021 · Open, Classified
  Palindrome RT Repair Kit 15 FR TAL 28cm, Sterile, Item Code 8888541128
• Z-2362-2021 · May 28, 2021 · Open, Classified
  Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 44cm, Item Code 8888541044
• Z-2359-2021 · May 28, 2021 · Open, Classified
  Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 23 cm, Item Code 8888541023
• Z-2363-2021 · May 28, 2021 · Open, Classified
  Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 55cm, Item Code 8888541055
• Z-2360-2021 · May 28, 2021 · Open, Classified
  Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 28 cm, Item Code 8888541028