Deltec 21-4152-24Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10610586012549), received between Dec 6, 2024 and Dec 6, 2024 — classified as 1 injury.

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

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

11 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. How this data works · Data updated Oct 13, 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-1279-2025 · Root cause: Process control · FDA record ↗

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.

• InjuryDec 6, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT THE PROPORT CATHETER DECOUPLED ONCE INSTALLED, AND A PART OF IT REMAINED INSIDE THE PATIENT. THE EVENT OCCURRED DURING USE WITH A PATIENT IN VITAL RISK. SINCE PART OF THE CATHETER WAS FOUND INTRAPULMONARY, INSTALLATION OF A NEW CATHETER HAD TO BE POSTPONED. INTERVENTION FOR SURGICAL REMOVAL WAS SCHEDULED FOR THE FOLLOWING WEEK. THE PATIENT ALSO SUFFERED A DELAY TO THEIR TREATMENT FOR BREAST CANCER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20864164 ↗

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-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-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-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-1287-2025 · Feb 13, 2025 · Open, Classified
  smiths medical ProPort Low Profile Plastic Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm (5.8Fr) O.D. x 1.0mm., 6Fr Introducer, REF 21-4183-24
• 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-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-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
• 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-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-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