Deltec 21-4454-24Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10610586032691), received between Feb 11, 2020 and Apr 29, 2022 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Defective Component” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 29, 2022Device Alarm System; Device Alarm System

  IT WAS REPORTED THAT A PATIENT REPORTED AN ISSUE WITH ONE OF HER CASSETTES LAST WEEK, PATIENT'S INFUSION WAS RUNNING, THEN A COUPLE HOURS LATER IT BEGAN TO ALARM WITH A NOT SPECIFIED ALARM. PATIENT TRIED RUNNING THE CASSETTE ON THE ALTERNATE PUMP AND IT HAD SAME ISSUE. PATIENT MIXED NEW CASSETTE AND WAS ABLE TO RESUME INFUSION. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14256018 ↗
• MalfunctionFeb 11, 2020Defective Component; Installation-Related Problem; Defective Component; Installation-Related Problem

  INFORMATION RECEIVED A SMITHS MEDICAL IMPLANTABLE PORTS/DELTEC POWER PORT-A-CATH II PORTS TUBE WAS DEFECTIVE. THIS WAS DISCOVERED DURING A OPERATION TO IMPLANT THE DEVICE. THE COMPLAINT STATES ANOTHER DEVICE WAS IMPLANTED AND NO PATIENT HARM. UNKNOWN IF THE DEFECT WAS NOTICED BEFORE IMPLANTATION AND ANOTHER KIT WAS OPENED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9694328 ↗
• MalfunctionFeb 11, 2020Defective Component; Installation-Related Problem; Defective Component; Installation-Related Problem

  INFORMATION RECEIVED A SMITHS MEDICAL IMPLANTABLE PORTS/DELTEC POWER PORT-A-CATH II PORTS TUBE WAS DEFECTIVE. THIS WAS DISCOVERED DURING A OPERATION TO IMPLANT THE DEVICE. THE COMPLAINT STATES ANOTHER DEVICE WAS IMPLANTED AND NO PATIENT HARM. UNKNOWN IF THE DEFECT WAS NOTICED BEFORE IMPLANTATION AND ANOTHER KIT WAS OPENED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9694327 ↗
• MalfunctionFeb 11, 2020Defective Component; Installation-Related Problem; Defective Component; Installation-Related Problem

  INFORMATION RECEIVED A SMITHS MEDICAL IMPLANTABLE PORTS/DELTEC POWER PORT-A-CATH II PORTS TUBE WAS DEFECTIVE. THIS WAS DISCOVERED DURING A OPERATION TO IMPLANT THE DEVICE. THE COMPLAINT STATES ANOTHER DEVICE WAS IMPLANTED AND NO PATIENT HARM. UNKNOWN IF THE DEFECT WAS NOTICED BEFORE IMPLANTATION AND ANOTHER KIT WAS OPENED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9694319 ↗
• MalfunctionFeb 11, 2020Defective Component; Installation-Related Problem; Defective Component; Installation-Related Problem

  INFORMATION RECEIVED A SMITHS MEDICAL IMPLANTABLE PORTS/DELTEC POWER PORT-A-CATH II PORTS TUBE WAS DEFECTIVE. THIS WAS DISCOVERED DURING A OPERATION TO IMPLANT THE DEVICE. THE COMPLAINT STATES ANOTHER DEVICE WAS IMPLANTED AND NO PATIENT HARM. UNKNOWN IF THE DEFECT WAS NOTICED BEFORE IMPLANTATION AND ANOTHER KIT WAS OPENED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9694318 ↗

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;