Deltec 21-4025-24Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10610586023804), received between Jul 28, 2017 and Jul 28, 2017 — classified as 2 injuries.

The most frequently reported specific device problem is “Disconnection” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K830730); 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJul 28, 2017Disconnection; Disconnection

  IT WAS REPORTED THAT THE CATHETER OF A DELTEC® PORT-A-CATH® IMPLANTABLE VENOUS ACCESS SYSTEM SEPARATED FROM THE PORT. THE PORT AND THE CATHETER WERE SURGICALLY REMOVED. NO PERMANENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6751803 ↗
• InjuryJul 28, 2017Disconnection; Disconnection

  IT WAS REPORTED THAT THE CATHETER OF A DELTEC® PORT-A-CATH® IMPLANTABLE VENOUS ACCESS SYSTEM SEPARATED FROM THE PORT. THE PORT AND THE CATHETER WERE SURGICALLY REMOVED. NO PERMANENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6751798 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K830730. One submission often covers many models, so check the product and lot details in each record.

• Z-0152-2016 · Sep 14, 2015 · Terminated
  PORT-A-CATH Plastic Hub Needles, 0.9mm (20G) x 19mm (3/4 in.) 90-degree. REF 21-2287-24 The Plastic hub PORT-A-CATH (PAC) needles are intended to access the implantable portal sy