Deltec 21-4153-24Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10610586012563), received between Nov 8, 2018 and May 7, 2025 — classified as 7 injuries, 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (4 reports).

1 FDA recall record name this device's identifier, 1 still open.

10 other recalls cover devices cleared under the same FDA submission (K994216); 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Feb 13, 2025Open, Classified

   The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.

   Z-1280-2025 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryMay 7, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT DURING THE INSTALLATION THE SURGEON EXAMINED THE PRODUCT, AND THE RESERVOIR WAS FOUND DETACHED FROM THE CAPSULE BASE. THERE WAS PATIENT INVOLVEMENT, AND A NEW DEVICE HAD TO BE IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21979730 ↗
• MalfunctionFeb 7, 2025Fluid/Blood Leak; Detachment of Device or Device Component; Fluid/Blood Leak; Detachment of Device or Device Component

  IT WAS REPORTED THAT AFTER THE CATHETER'S RESERVOIR WAS INSTALLED, IT LEAKED AND COMPLETELY FELL APART UNDER THE SUBCUTANEOUS TISSUE. IT WAS NECESSARY TO COMPLETELY REMOVE IT AND REINSTALLED A NEW ONE. THERE WERE PATIENT HARM OR ADVERSE EVENTS REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21337650 ↗
• InjuryFeb 4, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT DURING THE INSTALLATION THE SURGEON EXAMINED THE PRODUCT, AND THE RESERVOIR WAS FOUND DETACHED FROM THE CAPSULE BASE. THERE WAS PATIENT INVOLVEMENT, AND A NEW DEVICE HAD TO BE IMPLANTED.

  Patient problems: Insufficient Information

  MAUDE report 21307632 ↗
• InjuryApr 8, 2024Disconnection; Disconnection

  IT WAS REPORTED THAT THE CATHETER DETACHED FROM THE PORT, AND AN EMERGENCY INTERVENTION WAS REQUIRED TO REMOVE THE CATHETER THAT HAD BEEN DISPLACED TOWARDS THE HEART. THIS OCCURRED WITH TWO SEPARATE PATIENTS. THE PRODUCT WAS A SINGLE USE PRODUCT, USED ONE TIME FOR TWO WEEKS. THE OCCURRENCE OF THIS ISSUE WAS NOTICED AFTER THE INSERTION OF THE CATHETER. TWO PICTURES OF THE X-RAYS OF THE PATIENTS WERE PROVIDED. THE PATIENTS' GENDERS ARE UNKNOWN, AGED BETWEEN 60 TO 80 YEARS AND WITH CANCER IN THEIR MEDICAL HISTORY. THERE WAS MEDICAL INTERVENTION TO REMOVE THE CATHETER FROM THE PATIENTS. THERE WAS NO PATIENT HARM AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19067098 ↗
• InjuryFeb 24, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THE DEVICE WAS IMPLANTED IN PATIENT FOR VENOUS ACCESS DURING CHEMOTHERAPY. THE REPORTER STATED THAT ON THE SIXTH ROUND OF CHEMOTHERAPY INFUSIONS THE DRUG WAS ADMINISTERED AS PER USUAL AND SIX DAYS LATER PATIENT REPORTED PAIN AND REDNESS NEAR THE ACCESS SITE. IT WAS DETERMINED THE DEVICE WAS LEAKING AND EXTRAVASATION HAD OCCURRED CAUSING THE PAIN AND REDNESS. THE PORTAL SYSTEM WAS SURGICALLY REMOVED FROM PATIENT. NO FURTHER ADVERSE EFFECTS REPORTED.

  Patient problems: Pain; Skin Inflammation

  MAUDE report 11373742 ↗
• InjuryApr 23, 2020Detachment of Device or Device Component; Insufficient Device Problem Information; Detachment of Device or Device Component; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED INDICATING THAT UPON REMOVAL OF A SMITHS MEDICAL DELTEC PROPORT PORT FROM A PATIENT, PROBLEM AT THE LEVEL OF THE RESERVOIR WAS NOTED. IT WAS REPORTED THAT INJURY OCCURRED DUE TO THE NEED FOR EXTRACTION OF THE RESERVOIR. SUBSEQUENTLY, THE PORT WAS REMOVED, DISCARDED, AND REPLACED WITH ANOTHER. THERE WERE NO FURTHER ADVERSE EFFECTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9990136 ↗
• InjuryMar 10, 2020Leak/Splash; Detachment of Device or Device Component; Leak/Splash; Detachment of Device or Device Component

  INFORMATION WAS RECEIVED INDICATING THAT A FILTRATION PROBLEM OCCURRED TO A SMITHS MEDICAL DELTEC® PORT-A-CATH® PROPORT. IT WAS DECIDED TO NOT USE THE PORT FOR CHEMOTHERAPY ADMINISTRATION AND THE PORT WAS THEN EXPLANTED. UPON EXPLANT OF THE PORT, IT REPORTED THAT THE BASE OF THE RESERVOIR HAD DETACHED CAUSING SERUM EXTRAVASATION. THE PATIENT REQUIRED SURGICAL INTERVENTION AND HAD A NEW PORT PLACED. NO FURTHER ADVERSE EFFECTS WERE REPORTED.

  Patient problems: Extravasation

  MAUDE report 9810967 ↗
• InjuryNov 8, 2018Material Fragmentation; Detachment of Device or Device Component; Filtration Problem; Material Fragmentation; Detachment of Device or Device Component; Filtration Problem

  INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL DELTEC PROPORT IMPLANTABLE PORT HAD A FILTRATION ISSUE DURING CHEMOTHERAPY TREATMENT AND REQUIRED A CATHETER CHANGE. IT WAS REPORTED THE PATIENT EXPERIENCED DISCOMFORT AND WHILE ATTEMPTING TO REMOVE THE CATHETER, THE SURGEON NOTED THE BASE OF THE RESERVOIR WAS DETACHED. SUBSEQUENTLY, THE PATIENT NEEDED SURGICAL INTERVENTION TO REMOVE THE DEVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Discomfort

  MAUDE report 8053120 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K994216. One submission often covers many models, so check the product and lot details in each record.

• Z-1288-2025 · Feb 13, 2025 · Open, Classified
  smiths medical ProPort Low Profile Plastic Venous Access System, Silicone Catheter, 2.8mm (8.4Fr) O.D. x 1.0mm I.D., 9Fr Introducer, REF 21-4187-24
• Z-1281-2025 · Feb 13, 2025 · Open, Classified
  smiths medical ProPort Plastic Venous Access System, PolyFlow Polyurethane Catheter, 2.6mm O.D. (7.8Fr) x 1.6mm I.D., REF 21-4155-24
• Z-1283-2025 · Feb 13, 2025 · Open, Classified
  smiths medical ProPort Plastic Venous Access System, PolyFlow Catheter, 2.6 (7.8Fr) O.D. x 1.6mm I.D., 8.5Fr Introducer, REF 21-4171-24
• Z-1287-2025 · Feb 13, 2025 · Open, Classified
  smiths medical ProPort Low Profile Plastic Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm (5.8Fr) O.D. x 1.0mm., 6Fr Introducer, REF 21-4183-24
• Z-1282-2025 · Feb 13, 2025 · Open, Classified
  smiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter, 2.6mm (7.8Fr) O.D. x 1.6mm I.D., 8.6Fr Introducer, REF 21-4165-24
• Z-0872-04 · Mar 29, 2004 · Terminated
  ProPort Plastic Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter, 2.6mm O.D. x 1.6mm I.D., 8.5 French Introducer Set, REF 21-4165-24
• Z-0871-04 · Mar 29, 2004 · Terminated
  ProPort Plastic Venous Access System, with PolyFlow Polyurethane Catheter, 2.6mm O.D. x 1.6mm I.D., 8.5 French Introducer Set, REF 21-4155-24
• Z-0875-04 · Mar 29, 2004 · Terminated
  Port-A-Cath P.A.S. Port T2 Titanium Venous Access System, with PolyFlow Polyurethane Catheter, 1.9mm O.D. x 1.0mm I.D., 6 French Introducer Set, REF 21-4573-24
• Z-0874-04 · Mar 29, 2004 · Terminated
  ProPort Low Profile Plastic Venous Access System, with PolyFlow Polyurethane Catheter, 1.9mm O.D. x 1.0mm I.D., 6 French Introducer Set, REF 21-4183-24
• Z-0873-04 · Mar 29, 2004 · Terminated
  ProPort Low Profile Plastic Venous Access System, with PolyFlow Polyurethane Catheter, 2.6mm O.D. x 1.6mm I.D., 8.5 French Introducer Set, REF 21-4171-24