Deltec 21-4183-24Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10610586012778), received between Oct 3, 2019 and Jul 18, 2025 — classified as 3 injuries.

The most frequently reported specific device problem is “Fluid/Blood Leak” (1 report).

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

10 other recalls cover devices cleared under the same FDA submission (K994216); 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.

Recalls naming this device

1. Feb 13, 2025Open, Classified

   The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.

   Z-1287-2025 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJul 18, 2025Fracture; Fracture

  A PRODUCT LIABILITY LAWSUIT WAS RECEIVED THROUGH A WATCH SERVICE. THE LAWSUIT ALLEGES THE FOLLOWING: ON OR ABOUT (B)(6) 2023, THE PATIENT'S POWER PORT-A-CATH, 21-4483-24, LOT NUMBER 3894409 WAS EXPLANTED DUE TO FRACTURE IN THE CATHETER RESULTING IN EMBOLIZATION TO THE RIGHT ATRIUM AND VENTRICLE OF HER HEART. THIS DEVICE WAS IMPLANTED FOR THE PURPOSE OF ADMINISTERING CHEMOTHERAPY AND OTHER TREATMENTS ASSOCIATED WITH STAGE III NODE-POSITIVE MELANOMA OF THE SKIN ON A LOWER LIMB ON OR ABOUT (B)(6) 2020.

  Patient problems: Embolism/Embolus

  MAUDE report 22546462 ↗
• InjuryNov 20, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT WHEN THE IMPLANTABLE PORT WAS BEING REMOVED, THE CATHETER BROKE AND PART OF IT REMAINED LODGED IN THE SUPERIOR VENA CAVA. VASCULAR SURGERY WAS REQUIRED TO REMOVE THE CATHETER. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20738759 ↗
• InjuryOct 3, 2019Fluid/Blood Leak; Fluid/Blood Leak

  INFORMATION WAS RECEIVED INDICATING THAT A PATIENT EXPERIENCED EXTRAVASATION DURING THE USE OF A SMITHS MEDICAL SINGLE-LUMEN LOW PROFILE PORTAL. IT WAS REPORTED THAT AN ANGIOGRAPHY WITH CONTRAST MEDIUM WAS PERFORMED AND THAT THE CATHETER WAS SUBSEQUENTLY REPLACED. PER REPORTER AFTER ITS REMOVAL AND ON REVIEW, THE PORTAL WAS FOUND TO BE LEAKING FROM THE BASE OF THE CATHETER PORT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Extravasation

  MAUDE report 9153078 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K994216. One submission often covers many models, so check the product and lot details in each record.

• Z-1282-2025 · Feb 13, 2025 · Open, Classified
  smiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter, 2.6mm (7.8Fr) O.D. x 1.6mm I.D., 8.6Fr Introducer, REF 21-4165-24
• Z-1283-2025 · Feb 13, 2025 · Open, Classified
  smiths medical ProPort Plastic Venous Access System, PolyFlow Catheter, 2.6 (7.8Fr) O.D. x 1.6mm I.D., 8.5Fr Introducer, REF 21-4171-24
• Z-1288-2025 · Feb 13, 2025 · Open, Classified
  smiths medical ProPort Low Profile Plastic Venous Access System, Silicone Catheter, 2.8mm (8.4Fr) O.D. x 1.0mm I.D., 9Fr Introducer, REF 21-4187-24
• Z-1280-2025 · Feb 13, 2025 · Open, Classified
  smiths medical ProPort Plastic Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm (5.8Fr) O.D. x 1.0mm I.D., 6Fr Introducer, REF 21-4153-24
• Z-1281-2025 · Feb 13, 2025 · Open, Classified
  smiths medical ProPort Plastic Venous Access System, PolyFlow Polyurethane Catheter, 2.6mm O.D. (7.8Fr) x 1.6mm I.D., REF 21-4155-24
• Z-0874-04 · Mar 29, 2004 · Terminated
  ProPort Low Profile Plastic Venous Access System, with PolyFlow Polyurethane Catheter, 1.9mm O.D. x 1.0mm I.D., 6 French Introducer Set, REF 21-4183-24
• Z-0871-04 · Mar 29, 2004 · Terminated
  ProPort Plastic Venous Access System, with PolyFlow Polyurethane Catheter, 2.6mm O.D. x 1.6mm I.D., 8.5 French Introducer Set, REF 21-4155-24
• Z-0875-04 · Mar 29, 2004 · Terminated
  Port-A-Cath P.A.S. Port T2 Titanium Venous Access System, with PolyFlow Polyurethane Catheter, 1.9mm O.D. x 1.0mm I.D., 6 French Introducer Set, REF 21-4573-24
• Z-0872-04 · Mar 29, 2004 · Terminated
  ProPort Plastic Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter, 2.6mm O.D. x 1.6mm I.D., 8.5 French Introducer Set, REF 21-4165-24
• Z-0873-04 · Mar 29, 2004 · Terminated
  ProPort Low Profile Plastic Venous Access System, with PolyFlow Polyurethane Catheter, 2.6mm O.D. x 1.6mm I.D., 8.5 French Introducer Set, REF 21-4171-24