Deltec 21-4452-24Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10610586032677), received between Jan 9, 2025 and Feb 16, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 16, 2026Break; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT DURING SURGERY THAT THE PORT CHAMBER WAS DEFECTIVE AND COULD NOT BE USED. THE VALVE PROTRUDING FROM THE PORT CHAMBER WAS LOOSE. THE INCIDENT OCCURRED INTRAOPERATIVELY DURING THE PORT INSERTION PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT, NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24344348 ↗
• MalfunctionMar 7, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THREE DAYS AFTER BEING ADMINISTERED CHEMOTHERAPY THE PORT CHAMBER SEEMED TO BE LEAKING. THE PORT WAS INITIALLY IMPLANTED IN NOVEMBER OF 2024 WITH NO ISSUES VIA THE RIGHT CEPHALIC VEIN FOR A LEFT BREAST CARCINOMA. THE PORT WAS ACCESSED ON (B)(6) 2025 AND LOCAL SWELLING AND PAIN IN THE AREA WAS SEEN. THE INFUSION WAS STOPPED AND RADIOLOGICAL IMAGING WAS ORDERED. AFTER FLUIDS WERE INJECTED, A LARGE CONTRAST EXTRAVASATION WAS DETECTED. THE NEXT DAY, THE PATIENT PRESENTED WITH LEAKAGE AROUND THE PORT CHAMBER. ON (B)(6) 2025 THE PORT WAS REMOVED FROM THE PATIENT. DURING THE OPERATION, IT WAS OBSERVED THAT THE PORT SEEMED TO BE IN THE RIGHT POSITION WITH CORRECT FLOW. ONCE THE PORT WAS REMOVED, IT WAS FOUND THAT THE PORT CATHETER ON THE DORSAL SIDE WAS RUPTURED. THE SYSTEM WAS FULLY REMOVED AND A NEW PORT SYSTEM WAS IMPLANTED TO RESOLVE THE ISSUE.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 21553061 ↗
• MalfunctionJan 9, 2025Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  IT WAS REPORTED THAT THERE WAS A MATERIAL DEFECT, AND THE CUSTOMER HAD TO EXPLANT THE PORT AND IMPLANT A NEW ONE. THERE WAS PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21118146 ↗

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;