Nephro-Cath Nephrostomy Drainage Catheter NCL2-0835HBRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI H862NCL20835HB0), received between Dec 28, 2016 and Dec 28, 2016 — classified as 1 malfunction.

The most frequently reported specific device problem is “Detachment Of Device Component” (1 report).

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.

• MalfunctionDec 28, 2016Detachment Of Device Component; Expulsion; Detachment Of Device Component; Expulsion

  INCIDENT OCCURRED (B)(6) 2016 AND WAS REPORTED TO URESIL DISTRIBUTOR BY (B)(6) REPORT ON 2016-11-25. URESIL RECEIVED REPORT 2016-11-29. FROM INFORMATION PROVIDED IN THE ORIGINAL REPORT AND ADDITIONAL INFORMATION PROVIDED BY OUR DISTRIBUTOR, WE HAVE GATHERED THAT THE PHYSICIAN WAS ADVISED BY PATIENT'S FAMILY THAT THE STRESS RELIEF, OR BLUE COLLAR UNDER [DISTAL TO] THE HUB, DETACHED FROM THE HUB AND MIGRATED DOWN THE SHAFT OF THE CATHETER TO THE PIGTAIL, WHERE IT WAS STOPPED BY THE SUTURE/LOCKING MECHANISM AND BECAME LODGED UNDER THE PATIENT'S SKIN. PHYSICIAN DETERMINED BASED ON PATIENT CONDITION THAT NO ACTION WAS REQUIRED. REPORT INDICATES THAT THE PATIENT DEVELOPED CELLULITIS AND DISCHARGE AT THE WOUND SITE; IT IS UNCLEAR THE REASON FOR THE INFECTION AT THE WOUND SITE. THE STRESS RELIEF LATER CAME OUT OF THE CATHETER INSERTION SITE AND WAS DISCARDED.

  Patient problems: Cellulitis

  MAUDE report 6211566 ↗