Deltec 21-4453-24Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10610586032684), received between Sep 3, 2020 and Jan 24, 2025 — classified as 3 injuries, 1 malfunction.

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

• InjuryJan 24, 2025Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED THAT DURING THE OPERATION IT WAS DISCOVERED THAT THE CATHETER HAD A SMALL HOLE AT THE TRANSITION TO THE VENTRICLE. THERE WAS PATIENT INVOLVEMENT. THE PATIENT DETAILS: 57 YEARS OLD, GENDER: MALE. IT WAS REPORTED THAT THE PATIENT EXPERIENCED EXTRAVASATION OF CHEMOTHERAPEUTIC AGENT (OXALIPLATIN) INTO THE RIGHT DELTOIDEOPECTORAL REGION. THERE WAS PORT EXPLANTATION WITH LAVAGE ON (B)(6) 2024 WITH INTENDED SECONDARY WOUND HEALING. THE PATIENT ALSO EXPERIENCED TISSUE NECROSIS CAUSED BY THE LONG EFFECT OF THE TOXICITY OF THE CHEMOTHERAPY DRUG.

  Patient problems: Extravasation; Necrosis; Tissue Breakdown

  MAUDE report 21229476 ↗
• InjuryNov 4, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE TUBE FROM THE CATHETER TORE OFF RIGHT AT THE CONNECTION POINT. THE HOSE WAS INSERTED CORRECTLY UP TO THE STOP AND IS CLEARLY VISIBLE THROUGH THE SMALL HOLE. THE CATHETER HAD TO BE RETRIEVED VIA THE GROIN, WHICH REQUIRED A PARTIAL HOSPITALIZATION. THERE WAS PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20600131 ↗
• InjuryMay 9, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING REMOVAL, THE CATHETER BROKE OFF FROM THE CHAMBER AND MOVED TOWARDS THE HEART. THAT SAME DAY, THE PATIENT WAS TRANSFERRED TO A CLINIC FOR A MINIMALLY INVASIVE CATHETER INTERVENTION (MIKI) TO REMOVE THE FOREIGN BODY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16898662 ↗
• MalfunctionSep 3, 2020Leak/Splash; Mechanical Problem; Leak/Splash; Mechanical Problem

  IT WAS REPORTED THAT THE DELTEC POWER PORT-A-CATH II WAS SET ON THE 22-JULY. THERE WAS NO INDICATION OF A CONTRAST MEDIUM EXTRAVASATION IN THE C-ARM. THIS WAS NOT OBSERVED ON 22-JULY. ON 23-JULY CHEMOTHERAPY (EPIRUBICIN) WAS STARTED. THE PATIENT COMPLAINED OF A PRONOUNCED PAIN IN THE PORT AREA. A CLEAR EXTRAVASATION WAS FOUND DURING A FUNCTIONAL TEST WITH A MOBILE X-RAY. THE PORT WAS REMOVED ON THE SAME DAY AS A RESULT OF THIS. NO FURTHER PATIENT COMPLICATIONS WERE NOTED. THERE WAS NO DISCOLORATION OF THE CATHETER, HOWEVER A LEAK WAS VERIFIED ON THE CATHETER JUST TWO CM DISTAL TO THE AFOREMENTIONED SITE. THE OPERATOR NOTED A SLIT-SHAPED LESION IN THE CATHETER. THE DEFECTIVE PRODUCT WAS RETURNED TO THE MANUFACTURER FOR FURTHER DEVICE INVESTIGATION.

  Patient problems: Extravasation; Patient Problem/Medical Problem

  MAUDE report 10488246 ↗

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;