Deltec 21-4155-24Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10610586012594), received between Jan 22, 2020 and Jul 14, 2025 — classified as 9 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (3 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-1281-2025 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryJul 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PRODUCT LIABILITY LAWSUIT WAS RECEIVED THROUGH A WATCH SERVICE. THE LAWSUIT ALLEGES THE FOLLOWING: ON OR ABOUT (B)(6) 2023, THE PATIENT'S PROPORT, 21-4155-24, LOT NUMBER 4307473 WAS EXPLANTED DUE TO INFECTION AND CHEST WALL ABSCESS. THIS DEVICE WAS IMPLANTED FOR THE PURPOSE OF ADMINISTERING CHEMOTHERAPY AND OTHER TREATMENTS ASSOCIATED WITH TESTICULAR SEMINOMA AND LYMPHOMA ON OR ABOUT (B)(6) 2023.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 22498966 ↗
• InjuryMay 1, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE PORT LEAKED CAUSING SHOULDER PAIN. THERE WAS PATIENT INVOLVEMENT, AS THE PATIENT WOKE UP FROM SLEEP WITH PAIN TO THE LEFT SHOULDER AND NOTICED THE DRESSING AROUND THE PORT WAS LEAKING. THE PATIENT REPORTED TO THE EMERGENCY ROOM (ER) AND HAD EXPERIENCED SLIGHT RAISED EDEMA AROUND THE PORT. THERE WAS A MEDICAL INTERVENTION, CHEMOTHERAPY INFUSION WAS STOPPED, REMOVED THE NEEDLE FROM THE PORT, AND FLUSHED THE PORT. THE OUTCOME OF THE EVENT WAS THE PATIENT SHOWED UP TO THE ER, FOUR DAYS AFTER, WITH LEFT SHOULDER AND ARM PAIN. PAIN WORSE WITH MOVEMENT AND DEEP BREATHS. THE PORT WAS REMOVED BY THE SURGEON. PATIENT DATE OF BIRTH IS (B)(6) 1997. THE DATE OF EVENT WAS ON (B)(6) 2025 AND (B)(6) 2025.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 21942962 ↗
• InjuryMay 1, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE PORT LEAKED CAUSING SHOULDER PAIN. THERE WAS PATIENT INVOLVEMENT, AS THE PATIENT WOKE UP FROM SLEEP WITH PAIN TO THE LEFT SHOULDER AND NOTICED THE DRESSING AROUND THE PORT WAS LEAKING. THE PATIENT REPORTED TO THE EMERGENCY ROOM (ER) AND HAD EXPERIENCED SLIGHT RAISED EDEMA AROUND THE PORT. THERE WAS A MEDICAL INTERVENTION, CHEMOTHERAPY INFUSION WAS STOPPED, REMOVED THE NEEDLE FROM THE PORT, AND FLUSHED THE PORT. THE OUTCOME OF THE EVENT WAS THE PATIENT SHOWED UP TO THE ER, FOUR DAYS AFTER, WITH LEFT SHOULDER AND ARM PAIN. PAIN WORSE WITH MOVEMENT AND DEEP BREATHS. THE PORT WAS REMOVED BY THE SURGEON. PATIENT DATE OF BIRTH IS (B)(6) 1997. THE DATE OF EVENT WAS ON 3-APR-2025 AND 7-APR-2025.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 21942927 ↗
• MalfunctionApr 23, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE PORT LEAKED. AS THE PORT WAS DE-ACCESSED SWELLING WAS NOTED IN THE AREA ABOVE THE PORT NEAR THE PATIENT¿S LEFT SHOULDER AND AN ERYTHEMATOUS HALO WAS NOTED ABOVE THE PORT. THERE WAS NO MEDICAL INTERVENTION REQUIRED. THE SWELLING AND REDNESS AROUND THE PORT RESOLVED.

  Patient problems: Erythema; Swelling/ Edema

  MAUDE report 21892707 ↗
• MalfunctionOct 7, 2024Break; Break

  IT WAS REPORTED THAT THE FAULTY END OF CATHETER, HOSPITAL STATES THAT THE DEFECT AT THE END OF CATHETER WAS VISIBLE UPON OPENING THE BOX. THERE WAS NO PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20390661 ↗
• MalfunctionAug 31, 2022Disconnection; Disconnection

  IT WAS REPORTED THAT DEVICE WAS INSTALLED IN PATIENT ON (B)(6) 2019. ON (B)(6) 2019, PROBLEMS WERE DETECTED AFTER THE DEVICE WAS PUNCTURED, DETECTING FILTRATION. CHEST X-RAY PERFORMED. UPON REMOVAL OF DEVICE, IT WAS FOUND THAT THE BASE WAS NOT ATTACHED TO THE REST OF THE RESERVOIR. A NEW DEVICE WAS INSTALLED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15327571 ↗
• InjuryFeb 21, 2020Leak/Splash; Leak/Splash

  INFORMATION WAS RECEIVED THAT UPON ADMINISTRATION OF CHEMOTHERAPY THROUGH A SMITHS MEDICAL DELTEC IMPLANTABLE PORT, FILTRATION AND EXTRAVASATION OCCURRED. A PERIPHERAL ROUTE WAS INSTALLED AS A RESULT TO ADMINISTER PENDING CHEMOTHERAPY TREATMENT.

  Patient problems: Extravasation; Infiltration into Tissue

  MAUDE report 9740028 ↗
• InjuryFeb 19, 2020Leak/Splash; Leak/Splash

  INFORMATION WAS RECEIVED INDICATING THAT A PATIENT RECEIVING CHEMOTHERAPY THROUGH A SMITHS MEDICAL DELTEC® PROPORT PORTS IMPLANTABLE ACCESS SYSTEM WAS NOTED TO HAVE EXTRAVASATION. WITHDRAWAL WAS EFFECTIVELY PERFORMED TO VERIFY THAT STRUCTURAL FAILURE OCCURRED AT THE LEVEL OF THE UNION AT THE BASE OF THE RESERVOIR AND THAT IT EASILY UNCLOGS. THE PORT WAS LEFT IN PLACE AND CHEMO HAS BEEN CONTINUED VIA PERIPHERAL IV ROUTE. THERE WERE NO FURTHER REPORTED ADVERSE EFFECTS.

  Patient problems: Extravasation; Infiltration into Tissue

  MAUDE report 9730096 ↗
• InjuryFeb 19, 2020Leak/Splash; Leak/Splash

  INFORMATION WAS RECEIVED INDICATING THAT A PATIENT RECEIVING CHEMOTHERAPY THROUGH A SMITHS MEDICAL DELTEC® PROPORT PORTS IMPLANTABLE ACCESS SYSTEM WAS NOTED TO HAVE INFILTRATION AND LEAKAGE INTO THEIR TISSUE. SUBSEQUENTLY, THE PORT WAS EXPLANTED AND DISCARDED WITH NO FURTHER ADVERSE EFFECTS.

  Patient problems: Extravasation; Infiltration into Tissue

  MAUDE report 9730095 ↗
• InjuryFeb 19, 2020Decoupling; Connection Problem; Decoupling; Connection Problem

  IT WAS REPORTED THAT UPON ADMINISTRATION OF THE CHEMOTHERAPY, FILTRATION AND EXTRAVASATION (DAMAGE TO THE TISSUE) OCCURRED. THE OPERATOR SUSPECTED THAT THERE WAS A STRUCTURAL FAILURE FORM THE BASE OF THE RESERVOIR (EASILY DECOUPLES). THE OPERATOR STOPPED USING THE CATHETERS, AND PERIPHERAL ROUTES WERE ADMINISTERED IN ORDER TO DELIVER THE REMAINING VOLUME OF TREATMENT. THE PREVIOUS CATHETERS WERE LEFT IN PLACE HOWEVER. NO FURTHER COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.

  Patient problems: Extravasation; Patient Problem/Medical Problem

  MAUDE report 9728783 ↗
• MalfunctionJan 22, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED INDICATING THAT ONE MONTH FOLLOWING IMPLANT OF A SMITHS MEDICAL DELTEC® PROPORT PORT, IT WAS FOUND IN POOR CONDITION. THE PATIENT WENT TO THE OPERATING ROOM TO VERIFY PORT FUNCTION UNDER X-RAY. CHEMOTHERAPY WAS DISCONTINUED AND THE PORT WAS EXPLANTED. NO FURTHER ADVERSE EFFECTS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9618351 ↗
• InjuryJan 22, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED INDICATING THAT 14 WEEKS FOLLOWING IMPLANT OF A SMITHS MEDICAL DELTEC® PROPORT PORT, IT WAS FOUND IN POOR CONDITION. THE PATIENT WENT TO THE OPERATING ROOM TO VERIFY PORT FUNCTION UNDER X-RAY. CHEMOTHERAPY WAS DISCONTINUED AND THE PORT WAS EXPLANTED. NO FURTHER ADVERSE EFFECTS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9618350 ↗
• InjuryJan 22, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED INDICATING THAT FOUR MONTHS FOLLOWING IMPLANT OF A SMITHS MEDICAL DELTEC® PROPORT PORT, IT WAS FOUND IN POOR CONDITION. THE PATIENT WENT TO THE OPERATING ROOM TO VERIFY PORT FUNCTION UNDER X-RAY. CHEMOTHERAPY WAS DISCONTINUED AND THE PORT WAS EXPLANTED. NO FURTHER ADVERSE EFFECTS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9618349 ↗

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-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-1280-2025 · Feb 13, 2025 · Open, Classified
  smiths medical ProPort Plastic Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm (5.8Fr) O.D. x 1.0mm I.D., 6Fr Introducer, REF 21-4153-24
• 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-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-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-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-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
• 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-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-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