Deltec 21-4083-24Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 10610586023613), received between Jun 21, 2018 and Jul 14, 2025 — classified as 15 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (7 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 28 reports, in the reporter's own words as published by the FDA.

• InjuryJul 14, 2025Break; Migration; Break; Migration

  IT WAS REPORTED THAT A CHEST COMPUTERIZED TOMOGRAPHY (CT) SCAN WAS SHOWED A FOREIGN BODY IN THE PATIENT'S HEART. WHEN THE CLINICIAN REMOVED THE PORT, THEY FOUND THAT THE CATHETER HAD BROKEN NEAR THE CONNECTION WITH THE PORT. THE DOCTOR DISCOVERED THE PROBLEM AND PERFORMED AN INTERVENTIONAL SURGERY TO REMOVE THE CATHETER IN TIME. THERE WAS PATIENT INVOLVEMENT, AND THERE WERE UNKNOWN SIGNS OR SYMPTOMS EXPERIENCED, AND NO CASUALTIES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22494730 ↗
• MalfunctionJun 18, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  IT WAS REPORTED THAT A 69-YEAR-OLD-MALE PATIENT IN THE DEPARTMENT OF RADIOTHERAPY FOR ABDOMINAL TUMORS EXPERIENCED A 10CM 8CM SWELLING WITH TENDERNESS APPEARED AROUND THE INFUSION PORT. THE SKIN COLOR AROUND THE INFUSION PORT WAS NORMAL, AND THE SKIN TEMPERATURE WAS NORMAL. THE REPORTER NOTED THAT THE PATIENT HAD AN INFUSION PORT INSERTED ON (B)(6) 2023 AND HAD EXPERIENCED NO REACTIONS FOR MORE THAN A YEAR OF USE. ON (B)(6) 2025, THE PATIENT'S INFUSION PORT WAS FIXED AND UNOBSTRUCTED AND BLOOD COULD BE DRAWN BACK. ANTI-TUMOR PRETREATMENT WAS PERFORMED AT 9:59 WITHOUT ANY SPECIAL DISCOMFORT. AT 16:38, 500ML OF 5% GLUCOSE INJECTION PLUS 130MG OF OXALIPLATIN INJECTION WAS INTRAVENOUSLY INFUSED FOR ANTI-TUMOR TREATMENT AND THE PATIENT REACTED 10 MINUTES LATER. THE INFUSION WAS STOPPED IMMEDIATELY, AND THE ATTENDING PHYSICIAN AND NURSING TEAM LEADER WERE NOTIFIED, AND THE PATIENT WAS ADVISED TO REST IN BED. AFTER THE ACTING HEAD NURSE CONSULTED WITH THE EXPERTS OF THE INTRAVENOUS THERAPY SPECIALIST TEAM, THE NEEDLE WAS REMOVED AFTER BLOOD WAS RETURNED THROUGH THE ORIGINAL NEEDLE, THE SITE AND RANGE OF THE EXTRAVASATION WERE RECORDED, AND LIDOCAINE + DEXAMETHASONE INJECTION WAS GIVEN FOR

  Patient problems: Extravasation; Swelling/ Edema

  MAUDE report 22287819 ↗
• MalfunctionJun 13, 2025Connection Problem; Connection Problem

  IT WAS REPORTED THAT THE TUBING HAD BROKEN AND COULD NOT BE USED PROPERLY. THERE WAS NO REPORT OF ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22204128 ↗
• InjuryJun 13, 2025Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

  IT WAS REPORTED THAT WHEN CHEMOTHERAPY DRUGS WERE INFUSED, A 10CN*8CN SWELLING AND PAIN WERE FOUND AROUND THE INFUSION PORT. THE DEVICE WAS FOUND TO BE BROKEN. THEY IMMEDIATELY STOPPED THE INFUSION AND PERFORMED THE BLOCKADE TREATMENT.

  Patient problems: Extravasation

  MAUDE report 22204042 ↗
• MalfunctionMay 2, 2025Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT THE CATHETER COULD BE EASILY REMOVED AFTER THE CATHETER WAS CONNECTED TO THE LOCK DURING THE OPERATION. THERE WAS PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21953625 ↗
• MalfunctionMar 17, 2025Break; Break

  IT WAS REPORTED THAT WHEN THE CATHETER WAS ATTACHED TO THE LATCH, THE CATHETER BROKE IN THE LOCK. THERE WAS NO PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED. THERE IS ONE QUANTITY AFFECTED, AND ONE SAMPLE IS RETURNING FOR INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21626095 ↗
• MalfunctionJan 9, 2025Break; Break

  IT WAS REPORTED THAT DURING THE OPERATION, THE CATHETER BROKE WHILE THE DOCTOR WAS CONNECTING IT. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21118138 ↗
• MalfunctionOct 21, 2024Break; Break

  IT WAS REPORTED THAT THE CATHETER WAS FOUND TO BE BROKEN, AND THE PORT END WAS REMOVED BY SURGERY. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20495145 ↗
• MalfunctionOct 11, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT DEVELOPED REDNESS AND SWELLING OF THE SKIN AROUND THE NECK CATHETERIZATION SITE, AND PURULENT DISCHARGE WAS VISIBLE WHEN SQUEEZING. THE SKIN AROUND THE PATIENT'S CHEST WALL INFUSION PORT WAS SLIGHTLY RED AND SWOLLEN, AND SQUEEZING WAS PAINLESS. COLOR DOPPLER ULTRASONOGRAPHY OF BILATERAL INTERNAL JUGULAR VEINS SHOWED THAT THE RIGHT INTERNAL JUGULAR VEIN THROMBOSIS WAS GIVEN THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20432632 ↗
• MalfunctionJun 19, 2024Defective Device; Defective Device

  IT WAS REPORTED THAT DURING THE INFUSION PORT INSERTION OPERATION, IT WAS FOUND THAT THE CATHETER TIP WAS DAMAGED AND NOTCHED DURING THE PORT AND CATHETER WAS FLUSHED, A NEW SET OF INFUSION PORT WAS REPLACED. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19567059 ↗
• InjuryJun 5, 2024Fracture; Fracture

  IT WAS REPORTED THAT AN INTERVENTIONALIST PERFORMS AN INFUSION PORT IMPLANTATION PROCEDURE ON THE PATIENT, AND THE PATIENT UNDERWENT CHEMOTHERAPY FOR NEARLY A YEAR AFTER SURGERY. RECENT FINDINGS OF PATIENT DISCOMFORT AND POOR INFUSION, AND IMAGING REVEALED A BROKEN CATHETER AND SUBSEQUENT INTERVENTION WAS PERFORMED TO REMOVE THE CATHETER AND REMOVE THE PORT. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19469503 ↗
• InjuryJun 5, 2024Fracture; Material Separation; Fracture; Material Separation

  IT WAS REPORTED THAT AN INTERVENTIONALIST PERFORMS AN INFUSION PORT IMPLANTATION PROCEDURE ON THE PATIENT, AND THE PATIENT UNDERWENT CHEMOTHERAPY AND RADIOTHERAPY FOR NEARLY A YEAR AFTER SURGERY. RECENTLY, A POOR INFUSION WAS NOTED, AND IMAGING REVEALED A BROKEN CATHETER AND THAT THE BROKEN END HAD SLIPPED THROUGH THE SUPERIOR VENA CAVA INTO THE HEART. SUBSEQUENT INTERVENTION WAS PERFORMED TO REMOVE THE CATHETER AND REMOVE THE PORT. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19469292 ↗
• MalfunctionMay 22, 2024Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT AFTER PORT INSERTION, AN ATTEMPT WAS MADE TO ASPIRATE THE PORT CHAMBER, WHICH WAS UNSUCCESSFUL. RE-EXPOSURE OF THE PORT CHAMBER CONFIRMED THAT THE PORT CHAMBER WAS NOT FUNCTIONAL, PRESUMABLY THE CHAMBER CONTENTS HAD COAGULATED. THE PORT CHAMBER WAS THEN REPLACED. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19370480 ↗
• MalfunctionAug 11, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AFTER THE INFUSION PORT WAS IMPLANTED ON THE PATIENT, THE PORT MEMBRANE LEAKED. NO ADVERSE EFFECTS HAVE BEEN REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 17515607 ↗
• InjuryAug 8, 2023Fluid/Blood Leak; Material Separation; Fluid/Blood Leak; Material Separation

  IT WAS REPORTED THAT THE ONCOLOGY NURSE STATION RECEIVED A RETURN VISIT FROM A PATIENT. UPON INSPECTION, THE PATIENT'S INFUSION PORT AND PORT BODY WERE NOT ACCESSIBLE. THE "HONG KONG BODY" WAS BROKEN, WHICH WAS CONFIRMED WITH FILM ANALYSIS. IT WAS THEN REMOVED FROM THE PORT IN THE DIGITAL SUBTRACTION ANGIOGRAPHY (DSA) OPERATING ROOM. THE BREAK OCCURRED AT THE JUNCTION BETWEEN THE PORT BODY AND THE CATHETER. THE PATIENT INFUSION PORT WAS INSTALLED 4 YEARS AGO, AND THE SURGICAL LOCATION WAS ON THE UPPER ARM. SINCE THE HOSPITAL AND THE PATIENT'S OWN IMPLANT FILES ARE NOT KEPT, THE SPECIFIC BATCH NUMBER AND SPECIFIC SALES DATE CANNOT BE KNOWN. THE INCIDENT RESULTED IN NO "PATIENT CASUALTIES". THE FINAL RESULT WAS THAT THE "HONG KONG BODY" WAS REMOVED AND A NEW INFUSION PORT WAS IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17482152 ↗
• InjuryJul 13, 2023Fluid/Blood Leak; Material Separation; Fluid/Blood Leak; Material Separation

  IT WAS REPORTED, THAT THE TUBING WAS FOUND DAMAGED CAUSING LEAKAGE. THE PORT HAD BEEN IMPLANTED IN THE PATIENT FOR ABOUT 1.5 YEAR. THE PRODUCT WAS REMOVED BY SURGERY. AT THAT TIME, THE TUBING WAS FOUND SEPARATED FROM PORT.

  Patient problems: Insufficient Information

  MAUDE report 17317964 ↗
• MalfunctionJul 5, 2023Blocked Connection; Blocked Connection

  IT WAS REPORTED THAT, WHEN ATTEMPTING TO CONNECT THE CATHETER WITH THE INFUSION PORT SEAT, THE DOCTOR FOUND THAT THE CONNECTION OF THE INFUSION PORT SEAT WAS BLOCKED BY FOREIGN MATTERS AND COULD NOT BE CONNECTED WITH THE CATHETER; SO HE DID AN EMERGENCY REPLACEMENT OF THE CONSUMABLES AND THE OPERATION WAS COMPLETED SUCCESSFULLY. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17255083 ↗
• InjuryJun 8, 2023Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT ON (B)(6) 2018, THE ?SEAT" WAS BURIED IN THE CHEST WALL, AND ON (B)(6) 23, 2023, THE PATIENT REPORTED THAT HE WAS ?UNWELL". THE CONNECTION BETWEEN THE CATHETER AND THE PORT SEAT WAS FOUND TO BE BROKEN IN THE EMERGENCY DEPARTMENT. THE BROKEN END OF THE CATHETER SLIPPED TO THE BRACHIOCEPHALIC VEIN, AND THE TIP FELL TO THE HEART POSITION. THE RUPTURED CATHETER WAS REMOVED BY INTERVENTIONAL VENA CAVA FOREIGN BODY REMOVAL IN THE INTERVENTIONAL DEPARTMENT.

  Patient problems: Insufficient Information

  MAUDE report 17092396 ↗
• InjuryFeb 7, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THE PATIENT HAS A HISTORY OF INFUSION PORT DRUG IMPORTATION, SWELLING AND PAIN IN THE RIGHT BREAST AND SIDE CHEST AFTER INFUSION IN THE HOSPITAL, ACCOMPANIED BY SLIGHT PAIN; AT PHYSICAL EXAMINATION, EDEMA IN THE OUTER QUADRANT OF THE RIGHT BREAST AND SIDE CHEST AND ADNEXAL TISSUE OF THE PORT OF INFUSION PORT, NO REDNESS AND SWELLING OF THE SKIN, MILD TENDERNESS; CONTRAST EXAMINATION TO SEE A SMALL AMOUNT OF CONTRAST AGENT AROUND THE PORT SEAT; AFTER LOCAL TREATMENT, LOCAL PAIN, SWELLING AND OTHER SYMPTOMS ARE RELIEVED, EXPERT IDENTIFICATION: 1 DRUG EXTRAVASATION 2 INFUSION PORT SEAT LEAKAGE.

  Patient problems: Extravasation; Pain; Swelling/ Edema

  MAUDE report 16315257 ↗
• InjuryNov 23, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AFTER THE PATIENT WAS IMPLANTED IN THE INFUSION PORT, HE FOUND THAT THE RIGHT BREAST AND SIDE OF THE CHEST WERE SWOLLEN WITH SLIGHT PAIN, AND PHYSICAL EXAMINATION: THE OUTER QUADRANT OF THE RIGHT BREAST AND THE TISSUE NEAR THE PORT SEAT OF THE SIDE CHEST NEAR THE PORT OF INFUSION WERE EDEMATOUS, THE SKIN WAS NOT RED AND SWOLLEN, AND IT WAS MILDLY TENDER. CONTRAST EXAMINATION SHOWS THAT THERE IS A SMALL AMOUNT OF CONTRAST AGENT IN THE CATHETER PART, AND AFTER LOCAL TREATMENT, LOCAL PAIN, SWELLING AND OTHER SYMPTOMS ARE RELIEVED. EXPERT IDENTIFICATION: 1 DRUG EXTRAVASATION 2 CATHETER LEAKAGE.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 15854472 ↗
• InjuryDec 17, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE NEEDLE OF THE IMPLANTABLE INTRAVENOUS DRUG DELIVERY SYSTEM WAS BENT. THE NEEDLE WILL NOT GO INTO THE PATIENTS PORT. THE HOSPITAL ANALYZED THE CAUSE OF THE INCIDENT AND WAS UNABLE TO DETERMINE. IT WAS REPLACED.

  Patient problems: Insufficient Information

  MAUDE report 13030946 ↗
• MalfunctionSep 1, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE POSITION OF THE CAPSULE AFTER THE FLUID REPLACEMENT WAS SWOLLEN. AFTER THE CATHETER WAS REMOVED, LEAKAGE WAS FOUND BY ANGIOGRAPHY, THE DOCTOR REPLACED THE PORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12407492 ↗
• InjuryNov 9, 2020Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT THE PORT-A-CATH II PORT WAS IMPLANTED ON (B)(6) 2019 WITHOUT ANY COMPLICATIONS. THE DEVICE WAS BEING USED TO ADMINISTER CHEMOTHERAPY FOR OVARIAN CANCER. THE DEVICE FUNCTIONED AS INTENDED UNTIL (B)(6) 2020. A CHEST X-RAY WAS THEN TAKEN ON (B)(6) 2020. ACCORDING TO THE OPERATOR, THE X-RAY REVEALED THAT THERE WAS NOW AN UNSPECIFIED QUALITY ISSUE WITH DEVICE. THE DEVICE WAS EXPLANTED AS A RESULT. NO FURTHER COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.

  Patient problems: Therapeutic Response, Decreased

  MAUDE report 10810096 ↗
• MalfunctionSep 3, 2020Sharp Edges; Sharp Edges

  IT WAS REPORTED THAT WHILE IN USE, THE TIP OF THE INFUSION NEEDLE HAS A BARB. NO ADVERSE EFFECTS REPORTED.

  Patient problems: No Information

  MAUDE report 10489701 ↗
• InjuryJul 13, 2020Material Rupture; Material Rupture

  INFORMATION WAS RECEIVED INDICATING THAT DURING IMPLANT OF A SMITHS MEDICAL DELTEC PORT IMPLANTABLE ACCESS SYSTEM, THE SHEATH WAS REPORTED TO RUPTURE. THE INFUSION PORT WAS IMMEDIATELY STOPPED, AND NEW PORT WAS PLACED. THERE WERE NO REPORTED ADVERSE EFFECTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10264998 ↗

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-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-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-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