Deltec 21-4473-24Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10610586032752), received between Oct 20, 2017 and Oct 20, 2017 — classified as 2 injuries.

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

• InjuryOct 20, 2017Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping

  IT WAS REPORTED THAT A PRE-ATTACHED DELTEC® PORT-A-CATH® POWER P.A.C. WAS ASSEMBLED IN REVERSE. THE INCREMENTS STARTED AT 70 AT PORT INSTEAD OF 10. SURGEON IMPLANTED ONE PORT AND CUT THE CATHETER TOO SHORT BECAUSE OF THE CATHETER BEING REVERSED. THE PATIENT HAD TO RETURN TO SURGERY FOR THE PORT TO BE EXPLANTED. NO PERMANENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6966332 ↗
• InjuryOct 20, 2017Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping

  IT WAS REPORTED THAT A PRE-ATTACHED DELTEC® PORT-A-CATH® POWER P.A.C. WAS ASSEMBLED IN REVERSE. THE INCREMENTS STARTED AT 70 AT PORT INSTEAD OF 10. SURGEON IMPLANTED ONE PORT AND CUT THE CATHETER TOO SHORT BECAUSE OF THE CATHETER BEING REVERSED. THE PATIENT HAD TO RETURN TO SURGERY FOR THE PORT TO BE EXPLANTED. NO PERMANENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient; No Patient Involvement

  MAUDE report 6966331 ↗

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;