Deltec 21-4187-24Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10610586012839), received between Nov 2, 2017 and Nov 8, 2024 — classified as 1 injury, 2 malfunctions.

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

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. 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-1288-2025 · Root cause: Process control · 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.

• MalfunctionNov 8, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT WHEN THE SPECIALIST WAS ASSEMBLING THE IMPLANTABLE DEVICE, A RUPTURE IN THE BASE OF THE IMPLANTABLE CHAMBER WAS DETECTED. THIS OCCURRED DURING THE PRETEST. THERE WAS NO PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20640585 ↗
• MalfunctionOct 21, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A RUPTURE IN THE BASE OF THE IMPLANTABLE CHAMBER WAS DETECTED. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20500221 ↗
• InjuryNov 2, 2017Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED ONE MONTH FOLLOWING IMPLANT OF A SMITHS MEDICAL DELTEC® PORT-A-CATH® IMPLANTABLE VENOUS ACCESS SYSTEM THE PATIENT WAS NOTED TO HAVE EXTRAVASATION OF THE CHEMOTHERAPY. THE PATIENT HAD BEEN RECEIVING CHEMOTHERAPY FOR HEPATIC BILIARY CANCER. A CHEST X-RAY WAS ORDERED AND RESULTED THAT THE DEVICE HAD POSSIBLY MIGRATED INTO THE RIGHT VENTRICLE / ATRIUM. SUBSEQUENTLY, DUE TO THE RISK OF EMBOLIZATION, IT WAS REQUIRED THAT THE DEVICE BE EXPLANTED IN INTERVENTIONAL RADIOLOGY (IR). THE PATIENT RECOVERED WITH NO FURTHER ADVERSE EFFECTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6997733 ↗

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-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-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-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-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-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