Deltec 21-4474-24Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10610586039966), received between Jul 24, 2017 and Jun 15, 2022 — classified as 4 injuries, 1 malfunction.

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 15, 2022Partial Blockage; Obstruction of Flow; Partial Blockage; Obstruction of Flow

  IT WAS REPORTED THAT UPON OPENING IT WAS NOTICED THAT THE TIP OF THE CATHETER IS CLOSED ON THE PORT SIDE. NO INJURY OR PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14704385 ↗
• InjurySep 6, 2018Crack; Crack

  INFORMATION WAS RECEIVED INDICATING THAT A PATIENT WITH A SMITHS MEDICAL DELTEC® PORT-A-CATH®II WAS FOUND TO HAVE PAIN UPON FLUSHING. A VENOGRAM WAS ORDERED AND PERFORMED THAT DAY NOTING CRACKED TUBING. SUBSEQUENTLY, THE PORT WAS REQUIRED TO BE EXPLANTED AND REPLACED. NO FURTHER ADVERSE EFFECTS WERE REPORTED.

  Patient problems: Pain

  MAUDE report 7851612 ↗
• InjurySep 5, 2018Disconnection; Leak/Splash; Disconnection; Leak/Splash

  INFORMATION WAS RECEIVED INDICATING THAT FOLLOWING IMPLANT PROCEDURE OF A SMITHS MEDICAL DELTEC® PORT-A-CATH®II, THE PORT BECAME DISCONNECTED. THE PROCEDURE WAS UNABLE TO BE COMPLETED AS THE PATIENT HAD NOTED BLOOD LOSS AND MEDICATION INFUSED INTO THE TISSUE. SUBSEQUENTLY, THE PORT WAS EXPLANTED AND REPLACED WITH A NEW ONE. THERE WERE NO FURTHER ADVERSE EFFECTS.

  Patient problems: Blood Loss; Extravasation

  MAUDE report 7848369 ↗
• InjurySep 5, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED INDICATING THAT A PATIENT WITH A SMITHS MEDICAL DELTEC® PORT-A-CATH®II WAS FOUND TO HAVE AN INFECTED PORT POCKETS. SUBSEQUENTLY, IT WAS REQUIRED TO EXPLANT THE PORT AND REPLACE IT WITH A NEW ONE. NO FURTHER ADVERSE EFFECTS WERE REPORTED.

  Patient problems: Unspecified Infection

  MAUDE report 7848129 ↗
• InjuryJul 24, 2017Kinked; Kinked

  IT WAS REPORTED THAT APPROXIMATELY THREE MONTHS AFTER IMPLANTATION, A PORT STUDY SHOWED A KINK IN A DELTEC® PORT-A-CATH® II IMPLANTABLE VENOUS ACCESS SYSTEM. THE CATHETER WAS SURGICALLY REMOVED AND REPLACED WITH A NEW ONE. NO PERMANENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6736093 ↗

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;