MAHURKAR 8888145254Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20884521014326), received between Jan 29, 2020 and Jan 29, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Puncture/Hole” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

2 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.

Recalls naming this device

1. 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-1320-2022 · Root cause: Process control · Recall details · FDA record ↗

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 29, 2020Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, DURING MANIPULATION TO THE START OF THE TREATMENT, IT WAS NECESSARY TO DO A FLUSHING WITH A SOLUTION IN THE CATHETER PATHWAYS, WHICH BROKE THE EXTENSION TUBE DURING THE MANEUVER. THE CATHETER WAS NOT REPAIRED AND THERE WAS NO LEAK. TEGO WAS NOT UTILIZED AND THERE WAS NO LUER ADAPTER ISSUE. REPLACEMENT OF CATHETER WAS DONE AS MEDICAL OR SURGICAL INTERVENTION TO PREVENT PERMANENT IMPAIRMENT. POVIDINE IODINE WAS USED AS THE CLEANING AGENT FOR THE DEVICE AND FOR CLEANING THE INSERTION SITE PRIOR TO PRODUCT PLACEMENT. THE TREATMENT WAS PROCEEDED AND COMPLETED AFTER CATHETER REPLACEMENT. THERE WAS NO MEDICAL INTERVENTION DONE TO THE PATIENT. IT WAS ALSO STATED THAT THE EVENT DID NOT LEAD TO OR EXTEND PATIENT HOSPITALIZATION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9641871 ↗

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-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.