Deltec 21-4052-24Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10610586023521), received between Nov 5, 2024 and Dec 12, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Air/Gas in Device” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K830730); 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 16, 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.

• MalfunctionDec 12, 2024Crack; Air/Gas in Device; Crack; Air/Gas in Device

  IT WAS REPORTED THAT THE IRRIGATION CANNULA WAS CONNECTED TO THE CATHETER, AND WHEN ASPIRATION OCCURRED, AIR CAME BACK INSTEAD OF LIQUID. THEY NOTICED THAT THE END OF THE CATHETER WAS CRACKED. THE DEVICE WAS OPERATED BY THE PHYSICIAN. THE EVENT OCCURRED INTRAOPERATIVELY; THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20915341 ↗
• MalfunctionNov 5, 2024Material Split, Cut or Torn; Air/Gas in Device; Material Split, Cut or Torn; Air/Gas in Device

  IT WAS REPORTED THAT WHEN THE CATHETER WAS INSERTED AND ASPIRATION WAS ATTEMPTED, AIR RESURFACED INSTEAD OF BLOOD. IT WAS NOTICED THAT THE COATING OF THE CATHETER WAS TORN. A NEW CATHETER WAS USED AND THERE WERE NO NEGATIVE CONSEQUENCES FOR THE PATIENT. THE EVENT OCCURRED IN THE HOSPITAL, WHILE IN USE WITH THE PATIENT. THE OPERATOR OF THE DEVICE WAS A HEALTHCARE PROFESSIONAL. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20613318 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K830730. One submission often covers many models, so check the product and lot details in each record.

• Z-0152-2016 · Sep 14, 2015 · Terminated
  PORT-A-CATH Plastic Hub Needles, 0.9mm (20G) x 19mm (3/4 in.) 90-degree. REF 21-2287-24 The Plastic hub PORT-A-CATH (PAC) needles are intended to access the implantable portal sy