Deltec 21-4482-24Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10610586032769), received between Aug 18, 2017 and Aug 18, 2017 — classified as 1 injury.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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 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 18, 2017Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT FOLLOWING IMPLANT OF THIS DELTEC® PORT® POWER P.A.C. II, THE CATHETER WAS FOUND TO BE LEAKING, REQUIRING SURGICAL INTERVENTION. UPON IMPLANT, MULTIPLE NEEDLE PRICKS WERE MADE. SUBSEQUENTLY, A LEAK WAS OBSERVED 2 CM FROM THE TIP. THE DEVICE WAS EXPLANTED AND REPLACED WITH ANOTHER DEVICE, CAUSING A DELAY IN CHEMOTHERAPY. NO PERMANENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6804982 ↗

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; 2.