Deltec 21-4071-24Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10610586017841), received between Apr 21, 2020 and Sep 3, 2025 — classified as 3 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Crack” (3 reports).

8 other recalls cover devices cleared under the same FDA submission (K942024); 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 3, 2025Partial Blockage; Partial Blockage

  IT WAS REPORTED THAT THE INFUSION PORT CATHETER WAS BLOCKED, AND THE INFUSION WAS NOT SMOOTH. NO ADVERSE EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22951621 ↗
• InjuryFeb 7, 2022Fracture; Fracture

  IT WAS REPORTED FROM (B)(6) AE MONITORING SYSTEM, THAT 2 MONTHS AFTER THE INSTALLATION OF THE PORT, THE PATIENT FELT SWELLING AND PAIN WHEN FLUSHING FLUID. THE DOCTOR EXPLANTED THE PORT, AND FOUND CRACKS ALL AROUND THE CATHETER.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 13471771 ↗
• InjuryJun 21, 2021Crack; Crack

  INFORMATION RECEIVED A SMITHS MEDICAL IMPLANTABLE PORTS/DELTEC PORT-A-CATH II PORTS REQUIRED INTERVENTION OF SURGICAL REMOVAL. REPORTED TWO MONTHS AFTER THE PORT WAS INSTALLED, THE PATIENT FELT SWELLING. THE DOCTOR TOOK OUT THE PORT, AND FOUND THAT THERE WERE CRACKS AROUND THE CATHETER. PHOTO ATTACHED.

  Patient problems: Extravasation

  MAUDE report 12033831 ↗
• MalfunctionJun 21, 2021Crack; Crack

  INFORMATION RECEIVED A SMITHS MEDICAL IMPLANTABLE PORTS DELTEC PORT-A-CATH II PORTS REQUIRED INTERVENTION OF SURGICAL REMOVAL. REPORTED TWO MONTHS AFTER THE PORT WAS INSTALLED, THE PATIENT FELT SWELLING. THE DOCTOR TOOK OUT THE PORT, AND FOUND THAT THERE WERE CRACKS AROUND THE CATHETER. PHOTO ATTACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12033375 ↗
• InjuryJan 7, 2021Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  REPORTED AN ADVERSE EVENT OCCURRED WITH A SMITHS MEDICAL IMPLANTABLE PORTS/DELTEC PORT-A-CATH II PORTS . THE FACILITY REPORTED ON JULY 2ND JULY 2020 PER THIER WORDS. "THE PATIENT WAS HOSPITALIZED FOR CHEMOTHERAPY. AFTER USE THE PORTS INFUSED, THE PATIENT FELT PAIN AND SWELLED AROUND THE INFUSION PORT. 7-6 LINES OF ANGIOGRAPHY SHOWED THAT AT THE HORIZONTAL OF THE CERVICAL ROOT ABOUT THE C5 VERTEBRAL BODY, A SMALL AMOUNT OF CONTRAST AGENT EXUDED IN A FILAMENTOUS FORM, AND THE CONTRAST AGENT COULD BE SEEN ENTERING THE SUPERIOR VENA CAVA. CONSIDER CRACKS IN THE PIPELINE OF THE INFUSION PORT. DEEP VEIN THROMBOSIS AROUND THE LUMEN OF THE PATIENT REQUIRES ANTICOAGULATION THERAPY. THIS EVENT IS RISKY. IF IT IS NOT DISCOVERED AND HANDLED IN TIME, IT MAY CAUSE SERIOUS INJURY."

  Patient problems: Thrombosis

  MAUDE report 11137341 ↗
• MalfunctionApr 21, 2020Incorrect Measurement; Inadequacy of Device Shape and/or Size; Incorrect Measurement; Inadequacy of Device Shape and/or Size

  INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL DELTEC PORT-A-CATH II IMPLANTABLE ACCESS SYSTEM WAS NOTED TO HAVE INCONSISTENT SIZES THAN WHAT WAS PRINTED ON THE PACKAGING. IT WAS REPORTED THAT THE PACKAGING HAD THE CHINESE LOGO ON IT. SUBSEQUENTLY, THE SURGEON HAD TO RE-PUNCTURE THE PATIENT WITH THE CORRECT SIZE. THERE WERE NO REPORTED ADVERSE EFFECTS.

  Patient problems: Anxiety

  MAUDE report 9983073 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K942024. One submission often covers many models, so check the product and lot details in each record.

• Z-0064-2007 · Sep 27, 2006 · Terminated
  Locator-Wand Cover that is sold in a shelf carton (unit packaging) separate to the sterile tray containing and identified as PORT-A-CATH P.A.S. PORT T2 Fluoro-Free, Venous Access
• Z-0066-2007 · Sep 27, 2006 · Terminated
  Locator-Wand Cover that is sold in a shelf carton (unit packaging) separate to the sterile tray containing and identified as PORT-A-CATH II Fluoro-Free, Low Profile Venous Access S
• Z-0065-2007 · Sep 27, 2006 · Terminated
  Locator-Wand Cover that is sold in a shelf carton (unit packaging) separate to the sterile tray containing and identified as PORT-A-CATH P.A.S. PORT T2 Fluoro-Free, Venous Access
• Z-0804-06 · Mar 29, 2006 · Terminated
  Locator-Wand Cover that is sold in a shelf carton (unit packaging) separate to the sterile tray containing and identified as PORT-A-CATH II Fluoro-Free, Low Profile Venous Access
• Z-0802-06 · Mar 29, 2006 · Terminated
  Locator-Wand Cover that is sold in a shelf carton (unit packaging) separate to the sterile tray containing and identified as PORT-A-CATH P.A.S. PORT T2 Fluoro-Free, Venous Access
• Z-0805-06 · Mar 29, 2006 · Terminated
  Locator-Wand Cover that is sold in a shelf carton (unit packaging) separate to the sterile tray containing and identified as PORT-A-CATH II Fluoro-Free, Low Profile Venous Access
• Z-0803-06 · Mar 29, 2006 · Terminated
  Locator-Wand Cover that is sold in a shelf carton (unit packaging) separate to the sterile tray containing and identified as PORT-A-CATH P.A.S. PORT T2 Fluoro-Free, Venous Access
• Z-0442-05 · Nov 11, 2004 · Terminated
  Deltec branded PORT-A-CATH II Single-Lumen Low Profile Polysulfone/Titanium Venous Access System, Pre-assembled with PolyFlow, Ployurethane Catheter, 2.6 mm (7.8 Fr) O.D. x 1.6 mm