Deltec 21-4051-24Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10610586023514), received between Jan 20, 2021 and Jan 20, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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.

• InjuryJan 20, 2021Peeled/Delaminated; Device Dislodged or Dislocated; Material Integrity Problem; Peeled/Delaminated; Device Dislodged or Dislocated; Material Integrity Problem

  INFORMATION RECEIVED A SMITHS MEDICAL IMPLANTABLE PORTS/DELTEC PORT-A-CATH II PORTS WAS IMPLANTED ON THE RIGHT SIDE OF JUGULAR VEIN, SUBCLAVIAN VEIN, OR SUPERIOR VENA CAVA. NOT SPECIFIED. WHICH VEIN. A PATIENT WAS EXPERIENCING GENERAL MALAISE, COUGH AND CHEST AGITATION, SO AN X-RAY WAS PERFORMED AND THE DOCTOR INDICTED THE CATHETER SHOULD BE TAKEN OUT AND PLACED ON THE LEFT SIDE. UPON SURGICAL INTERVENTION TO REMOVE THE CATHETER, IS WAS REPORTED NOT SUCCESSFUL AND THE CATHETER WAS BROKEN OFF 10-12 CM FROM THE PORT WITHOUT A VISIBLE STUMP FOR EXTRACTION. REPORTED ON (B)(6) 2020 CATHETER WAS EXTRACTED BY INTERVENTION RADIOLOGY. THE COMPLAINT TALKED ABOUT PATIENT SUFFERING FROM HICCUPS ON GOING AND BEING TREATED WITH METOCLOPORAMIDE. UNKNOWN PATIENT STATUS AT THIS TIME

  Patient problems: Chest Pain; Weakness

  MAUDE report 11202455 ↗

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