Deltec 21-4069-24Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10610586039935), received between Oct 15, 2024 and Oct 15, 2024 — classified as 1 injury.

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

6 other recalls cover devices cleared under the same FDA submission (K962695); 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.

• InjuryOct 15, 2024Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT WENT TO EMERGENCY DEPARTMENT WITH COMPLAINTS OF ABDOMINAL PAIN AND NAUSEA. BLOOD CULTURES WERE DRAWN ON AND WERE POSITIVE FOR VRE BACTEREMIA. PATIENT'S MEDICAL TEAM DETERMINED THAT THE PORT-A-CATH WAS THE SOURCE OF THE INFECTION, AND THE DEFECTIVE PORT HAD TO BE REMOVED. INFECTION, NAUSEA AND SEVERE PERSISTENT PAIN WAS EXPERIENCED BY THE PATIENT ALONG WITH THE ADDITIONAL SURGERY.

  Patient problems: Nausea; Pain; Respiratory Tract Infection

  MAUDE report 20453590 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K962695. One submission often covers many models, so check the product and lot details in each record.

• Z-0869-04 · Mar 29, 2004 · Terminated
  Port-A-Cath II Low Profile Polysulfone/Titanium Venous Access System, with PolyFlow Polyurethane Catheter, 1.9mm O.D. x 1.0mm I.D., 6 Fr Introducer Set, REF 21-4083-24
• Z-0867-04 · Mar 29, 2004 · Terminated
  Port-A-Cath II Low Profile Polysulfone/Titanium Venous Access System, with PolyFlow Polyurethane Catheter, 2.6mm O.D. x 1.6mm I.D., 8.5 Fr Introducer Set, REF 21-4071-24
• Z-0868-04 · Mar 29, 2004 · Terminated
  Port-A-Cath II Low Profile Polysulfone/Titanium Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter, 2.6mm O.D. x 1.6mm I.D., 8.5 Fr Introducer Set, REF 21-4073
• Z-0866-04 · Mar 29, 2004 · Terminated
  Port-A-Cath II Polysulfone/Titanium Venous Access System, with PolyFlow Polyurethane Catheter, 2.6mm O.D. x 1.6mm I.D., 8.5 Fr Introducer Set, REF 21-4055-24
• Z-0876-04 · Mar 29, 2004 · Terminated
  Port-A-Cath II Fluoro-Free Low Profile Venous Access System, with PolyFlow Polyurethane Catheter, 2.6mm O.D. x 1.6mm I.D., and with CATH-FINDER Sensor Wire, REF 21-4685-24
• Z-0870-04 · Mar 29, 2004 · Terminated
  Port-A-Cath II Low Profile Polysulfone/Titanium Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter, 1.9mm O.D. x 1.0mm I.D., 6 Fr Introducer Set, REF 21-4085-2