Deltec 21-4063-24Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10610586023576), received between Mar 27, 2020 and Mar 27, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Leak/Splash” (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 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.

• InjuryMar 27, 2020Leak/Splash; Leak/Splash

  INFORMATION WAS RECEIVED INDICATING THAT A PHYSICIAN WAS UNABLE TO DRAW BLOOD FROM A SMITHS MEDICAL DELTEC® PORT-A-CATH®II IMPLANTABLE ACCESS SYSTEM. THE PATIENT WAS THEN SENT TO THE HOSPITAL FOR A PORT CHECK AND WAS OBSERVED TO HAVE EXTRAVASATION TO THE LEFT CLAVICLE REGION UNDER FLUOROSCOPY. SUBSEQUENTLY, THE PORT WAS EXPLANTED, DISCARDED AND REPLACED WITH A NEW ONE IN INTERVENTIONAL RADIOLOGY. THERE WERE NO FURTHER REPORTED ADVERSE PATIENT EFFECTS.

  Patient problems: Extravasation

  MAUDE report 9887343 ↗

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-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-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-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-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
• 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-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