Deltec 21-4023-24Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10610586023781), received between Aug 12, 2021 and Aug 12, 2021 — classified as 1 injury.

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

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 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.

• InjuryAug 12, 2021Separation Failure; Separation Failure

  INFORMATION RECEIVED A SMITHS MEDICAL IMPLANTABLE PORTS/DELTEC PORT-A-CATH PORTS CATHETER WAS INTERNALLY TORN AT CONNECTION PIECE BETWEEN PORT CHAMBER AND CATHETER. CATHETER PLACED IN 2003. THE CATHETER HAD NOT BEEN USED FOR YEARS, ONLY FLUSHING EVERY 3 MONTHS. NO BLOOD COULD BE ASPIRATED DURING THE LAST FLUSHING ATTEMPT BY THE HOME NURSE. THE GATE WAS RE-PIERCED SEVERAL TIMES AT HOME, STILL IN1AS3. MADE AN APPOINTMENT WITH THE PATIENT IN THE HOSPITAL TO LOOK AT THE FUNCTIONAL PROBLEM. PORT CATHETER WAS PUNCTURED WITH A 15MM HUBER POINT NEEDLE, SMOOTH PUNCTURE, IN1AS3. HOWEVER, UPON INFUSION SWELLING IS VISIBLE ABOVE THE PORT. CATHETER WAS REMOVED ON (B)(6) 2021, INTERNALLY TORN AT CONNECTION PIECE BETWEEN PORT CHAMBER AND CATHETER.

  Patient problems: Swelling/ Edema

  MAUDE report 12314478 ↗

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