Deltec 21-4437-24Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00610586032663), received between Jul 31, 2018 and Jun 2, 2022 — classified as 2 injuries.

The most frequently reported specific device problem is “Crack” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJun 2, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PORT DEVICE WAS IMPLANTED IN (B)(6) 2017 FOR ADJUVANT SYSTEMIC ANTINEOPLASTIC THERAPY FOR COLON CANCER, WITH A HIGH RISK OF RECURRENCE. CHEMOTHERAPY COMPLETED IN (B)(6) 2017, DEVICE KEPT IN PLACE SINCE THEN AND REGULARLY SUBJECTED TO MAINTENANCE WASHINGS DURING THE FIVE YEARS OF FLUOROURACIL. IN (B)(6) 2022 (LAST VISIT), REMOVAL WAS REQUESTED DUE TO THE MALFUNCTION AND AFTER 5 YEARS FROM THE INSTALLATION. DURING THE REMOVAL PROCEDURE, EVIDENCE OF CVC DISLOCATION FROM THE BODY WAS NOTED, REQUIRING REMOVAL WITH AN ANGIOGRAPHIC PROCEDURE.

  Patient problems: Reaction to Medicinal Component of Device

  MAUDE report 14575493 ↗
• InjuryJul 31, 2018Crack; Crack

  INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL IMPLANTABLE PORT-A-CATH HAD A TEAR FOLLOWING PLACEMENT. THIS REQUIRED A REPLACEMENT PORT FOR THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7736487 ↗

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;