Deltec 21-4170-24Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10610586012693), received between Aug 16, 2023 and Aug 16, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (1 report).

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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 16, 2023Patient Device Interaction Problem; Physical Resistance/Sticking; Patient Device Interaction Problem; Physical Resistance/Sticking

  IT WAS REPORTED THAT A PATIENT HAD PORTA CATH INSERTION ON (B)(6) 2015 AND WAS SCHEDULED FOR PORTA CATH REMOVAL ON (B)(6) 2023. UPON ATTEMPTED REMOVAL, DIFFICULTY WAS ENCOUNTERED. THE PORT WAS SUCCESSFULLY REMOVED AT CHEST INCISION. NECK INCISION WAS MADE, AND THE CATHETER WAS FOUND TO BE DENSELY ADHERENT AND UNABLE TO BE FREED DESPITE EXPLORATION DOWN TO RETRO CLAVICULAR AREA. EXPLORATION OF RIGHT UPPER CHEST WOUND. PORT SUCCESSFULLY REMOVED, CATHETER REMOVAL WITH RESISTANCE PLUS EXPLORATION OF NECK WOUND: CATHETER WAS DENSELY ADHERENT, UNABLE TO FREE ADHESION DESPITE EXPLORATION DOWN TO RETRO CLAVICULAR AREA. EVENT OCCURRED WHILE IN USE WITH THE PATIENT, BUT NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17560180 ↗

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-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-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-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-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-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-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-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-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-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