Deltec 21-4436-24Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10610586032653), received between Sep 28, 2020 and Sep 28, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Difficult to Advance” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K072657); 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.

• InjurySep 28, 2020Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT WHILE FLUSHING THE SMITHS MEDICAL PORT SYSTEM THERE WAS AN USUAL RESISTANCE, THE RESISTANCE SUDDENLY INCREASED ABRUPTLY. A PERFORMED X RAY SHOWED A RUPTURE OF THE INTRAVASCULAR TUBE. THE DETACHED TUBE WAS RECOVERED BY AN INTERVENTIONAL RADIOLOGY AND THE REMAINING PORT SYSTEM IS STILL IN SITU. A SONOGRAPHICALLY PROVEN THROMBOSIS OF THE RIGHT SUBCLAVIAN VEIN. NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10591695 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K072657. One submission often covers many models, so check the product and lot details in each record.

• Z-2499-2020 · Jun 11, 2020 · Terminated
  PORT-A-CATH II POWER P.A.C. Low Profile" system.
• Z-0190-2020 · Jul 8, 2019 · Terminated
  GRIPPER Needles sold as part of PORT-A-CATH II SINGLE LUMEN SYSTEM. Labeled as the following item descriptions: 1. TRAY, PAC, VEN, TI, PU, 1.9MM, UL, 6FR/INTRO 1/EA;