Palindrome 8888133504Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884521056633), received between May 6, 2019 and May 6, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

3 other recalls cover devices cleared under the same FDA submission (K111372); 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.

• MalfunctionMay 6, 2019Break; Break

  ACCORDING TO THE REPORTER, WHILE INSERTING THE CATHETER, THE PHYSICIAN HAD DIFFICULTY REMOVING ONE OF THE STYLETS FROM THE CATHETER. THE MIDDLE PART OF THE STYLET BROKE IN HALF WITH THE ATTEMPTED REMOVAL AFTER THE CATHETER PLACEMENT; WHEREIN 1/2 WAS IN THE PHYSICIAN¿S HANDS AND THE OTHER HALF WAS STUCK INSIDE THE CATHETER, SO IT HAD TO BE REMOVED AND ANOTHER CATHETER WAS PLACED WITH NO ISSUES NOTED. NO BROKEN FRAGMENTS WERE LEFT INSIDE THE PATIENT. NO CLEANING AGENT WAS USED ON THE DEVICE, BUT CHLORO-PREP WAS USED TO CLEAN THE INSERTION SITE BEFORE THE PROCEDURE/PRODUCT PLACEMENT. IT WAS ALSO STATED THAT THE CATHETER WAS NOT REPAIRED, THERE WAS NO LEAK, TEGO WAS NOT UTILIZED, AND THERE WAS NO LUER ADAPTER ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8584873 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K111372. One submission often covers many models, so check the product and lot details in each record.

• Z-2632-2023 · Aug 22, 2023 · Open, Classified
  Palindrome Chronic Catheter Kit Symmetrical Tip14.5 Fr/Ch(4.8mm)x23cm
• Z-1320-2022 · Jun 8, 2022 · Open, Classified
  Mahurkar Chronic Carbothane (Maxid) Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and infusion.
• Z-1316-2022 · Jun 8, 2022 · Open, Classified
  Palindrome Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access for acute and chronic hemodialysis, apheresis, and infusion.