Palindrome 8888541033Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884521135505), received between Oct 22, 2018 and Oct 22, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (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 18, 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.

• MalfunctionOct 22, 2018Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  ACCORDING TO THE REPORTER, DURING USE, THERE WERE LEAKAGE AND FISSURE AT THE BLUE CONNECTOR OF THE PALINDROME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7991934 ↗

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-2368-2021 · May 28, 2021 · Open, Classified
  Palindrome RT Repair Kit 15 FR TAL 44cm, Sterile, Item Code 8888541144
• Z-2364-2021 · May 28, 2021 · Open, Classified
  Palindrome RT Repair Kit 15 FR TAL 19cm, Sterile, Item Code 8888541119
• Z-2365-2021 · May 28, 2021 · Open, Classified
  Palindrome RT Repair Kit 15 FR TAL 23cm, Sterile, Item Code 8888541123
• 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
• 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-2366-2021 · May 28, 2021 · Open, Classified
  Palindrome RT Repair Kit 15 FR TAL 28cm, Sterile, Item Code 8888541128
• 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-2367-2021 · May 28, 2021 · Open, Classified
  Palindrome RT Repair Kit 15 FR TAL 33cm, Sterile, Item Code 8888541133
• 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-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-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-2369-2021 · May 28, 2021 · Open, Classified
  Palindrome RT Repair Kit 15 FR TAL 55cm, Sterile, Item Code 8888541155