Deltec 21-4483-24Recalls & reported problems

Summary

The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 10610586032776), received between Feb 16, 2018 and Apr 24, 2026 — classified as 26 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (9 reports).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 42 reports, in the reporter's own words as published by the FDA.

• InjuryApr 24, 2026Device Appears to Trigger Rejection

  A PRODUCT LIABILITY LAWSUIT WAS RECEIVED THROUGH A WATCH SERVICE. THE LAWSUIT ALLEGES THE FOLLOWING: ON OR ABOUT (B)(6) 2024, THE PATIENT¿S PORT-A-CATH II POWER P.A.C., ITEM NUMBER 21-4483-24, AND LOT NUMBER 4420780, WAS EXPLANTED DUE TO REDNESS, SWELLING, AND TENDERNESS AT THE PORT SITE. THE DEVICE WAS IMPLANTED FOR THE PURPOSE OF ADMINISTERING CHEMOTHERAPY AND INTRAVENOUS ACCESS TO TREAT METASTATIC ANAL CANCER ON OR ABOUT (B)(6) 2023.

  Patient problems: Cellulitis; Erythema; Swelling/ Edema

  MAUDE report 24983923 ↗
• MalfunctionDec 4, 2025Break; Leak/Splash; Break; Leak/Splash

  IT WAS STATED IN THE REPORT THAT EXPERIENCED SUBCUTANEOUS LEAKAGE FROM THE INFUSION THE DAY AFTER PORT PLACEMENT, AFTER THE DOCTOR EXAMINED THE SITUATION AND REOPENED THE SURGICAL INCISION TO REMOVE THE PORT, IT WAS FOUND THAT THE CATHETER WAS BROKEN, SO THE PRODUCT WAS REPLACED FOR USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23715416 ↗
• InjuryNov 12, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  A LAWSUIT WAS RECEIVED REGARDING PORT-A-CATH IMPLANTABLE ACCESS SYSTEM WITH LIST NUMBER 21-4483-24 AND LOT NUMBER 4163578 CONTAINING THE FOLLOWING ALLEGATIONS. ON (B)(6) 2021 THE PATIENT UNDERWENT PLACEMENT OF THE DEVICE FOR THE PURPOSE OF ONGOING TREATMENT FOR ADMINISTERING CHEMOTHERAPY. ON OR ABOUT (B)(6) 2023, PATIENT DEVELOPED A BLOOD CLOT ALONG WITH SEVERE PAIN AND PERSISTENT PAIN AROUND THE POWERPAC. PATIENT WAS TREATED FOR THE BLOOD CLOT WITH BLOOD THINNERS AND ON OR AROUND (B)(6) 2023 THE PORT WAS REMOVED.

  Patient problems: Pain; Thrombosis/Thrombus

  MAUDE report 23534308 ↗
• MalfunctionNov 4, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE PATIENT HAD AN INFUSION PORT INSERTED IN THE MEDIAL SIDE OF THE LEFT UPPER ARM. DURING THE INFUSION OF SUPPORTIVE FLUIDS, THE PATIENT EXPERIENCED PAIN AND SWELLING IN THE LEFT UPPER ARM, AND THE SKIN APPEARED PALE. THE NURSE IMMEDIATELY STOPPED THE INFUSION AND FOUND NO BLOOD RETURNED UPON ASPIRATION. THE INFUSION WAS THEN CONTINUED THROUGH A PERIPHERAL VEIN INSTEAD. UPON REMOVAL, LEAKAGE WAS OBSERVED IN THE INFUSION PORT TUBING. THERE WAS PATIENT INVOLVEMENT, BUT NO HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23465524 ↗
• MalfunctionOct 16, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THE CATHETER HAD BURST AND WAS REMOVED. THERE WAS PATIENT INVOLVEMENT, NO INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23310460 ↗
• InjurySep 15, 2025Break; Break

  IT WAS REPORTED THAT SEVERAL PLASTIC PARTS OF THE SYSTEM DETACHED AND ENTERED THE PATIENT'S BLOOD VESSELS. THE PATIENT RECEIVED A PORT-A-CATH AND CAME IN FOR A CHECK-UP BECAUSE THE TUBE APPEARED TO HAVE DETACHED FROM THE CHAMBER. HOWEVER, THE X-RAY SHOWED THAT THE CATHETER WAS BROKEN IN SEVERAL PLACES AND THAT PIECES OF THE CATHETER WERE IN THE LUNG. THE PORT COULD NOT BE REMOVED BECAUSE THERE WAS A HIGH RISK OF MORE PIECES OF TUBING EMBOLIZING INTO THE LUNGS. THE PORT MUST BE REMOVED SURGICALLY. AS IMMEDIATE MEASURES THE REPORTER ENUMERATES THE FOLLOWING: THE PATIENT WAS ADMITTED TO THE HOSPITAL. THE DETACHED PIECES OF TUBING FROM THE LUNGS WERE RETRIEVED USING CATHETER TECHNOLOGY VIA A TRANSFEMORAL VENOUS ACCESS IN THE CARDIAC CATHETERIZATION LABORATORY (CCL). THE REMOVED PARTS WERE PRESERVED AND SECURED IN TUBES. ADDITIONALLY, FURTHER ACTION TAKEN WAS SURGICAL REMOVAL OF THE REMAINING DEFECTIVE PORT-A-CATH SYSTEM IS PLANNED AND THE PATIENT WILL BE CALLED IN FOR THIS. THE INCIDENT HAPPENED DURING THE REVISION OF THE PORT A CATH. THIS PRODUCT WAS INSERTED INTO THE PATIENT ON (B)(6) 2024. THERE WAS PATIENT INVOLVEMENT AND ADVERSE EVENT REPORTED.

  Patient problems: Airway Obstruction; Device Embedded In Tissue or Plaque

  MAUDE report 23058103 ↗
• InjurySep 10, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING THE PORT-A-CATHETER EXPLANTATION PROCEDURE, IT WAS DETERMINED THAT THE CATHETER HAD BEEN TORN OFF. THE CATHETER FRAGMENT HAD TO BE REMOVED THROUGH THE GROIN DURING A FOLLOW-UP SURGICAL PROCEDURE. THERE WAS PATIENT INVOLVEMENT, AND THERE WAS NO DELAY IN THERAPY.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23015769 ↗
• MalfunctionAug 6, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE CATHETER HAD A HOLE, CAUSING IT TO LEAK. THE FLUID LIKELY ENTERED THE SURROUNDING TISSUE INSTEAD OF THE VEIN, LEADING TO SWELLING AND EDEMA. THE PATIENT WAS INVOLVED, BUT NO INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22726169 ↗
• InjuryJun 11, 2025Device Appears to Trigger Rejection; Adverse Event Without Identified Device or Use Problem; Device Appears to Trigger Rejection; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE MEDICAL DEVICE WAS IMPLANTED WITHOUT CONSENT FOR BREAST CANCER AWARENESS RESEARCH AND STARTED SENDING SHARP PAINS THROUGHOUT THE PATIENTS NECK AND CHEST.

  Patient problems: Chest Pain; Neck Pain; Pain

  MAUDE report 22188487 ↗
• MalfunctionMay 30, 2025Separation Problem; Separation Problem

  IT WAS REPORTED THAT DURING THE CATHETERIZATION PROCESS THE TIP OF THE PUNCTURE SHEATH WAS SPLIT WHEN IT WAS BEING INSERTED. THERE WERE NO PATIENT HARM OR ADVERSE EVENTS REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22118652 ↗
• MalfunctionApr 3, 2025Break; Disconnection; Break; Disconnection

  IT WAS REPORTED THAT FEMALE-BREAST-CANCER-PATIENT UNDERWENT CHEMOTHERAPY AFTER SURGERY, HAD AN INFUSION PORT IMPLANTATION VIA THE JUGULAR VEIN UNDER ULTRASOUND IN MARCH AND WAS READMITTED FOR FOUR CHEMOTHERAPY CYCLES. UPON RE-ADMISSION AFTER COMPLETING FOUR CYCLES OF CHEMOTHERAPY, SHE WAS ADMITTED TO THE HOSPITAL FOR ANOTHER EXAMINATION. A CHEST X-RAY SHOWED THAT THE INFUSION PORT CATHETER HAD BROKEN AND FALLEN INTO THE RIGHT ATRIUM. THE CATHETER WAS THEN REMOVED VIA THE INFERIOR VENA CAVA. IT WAS MENTIONED IN THE COMPLAINT THAT THE DEVICE IS AVAILABLE FOR RETURN. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21766116 ↗
• MalfunctionMar 28, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT IT WAS FOUND THAT THE CHEMOTHERAPY DRUGS WERE LEAKING FROM THE DEVICE. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21721053 ↗
• MalfunctionFeb 18, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE PAC SYSTEM (A CAPSULE THAT IS PLACED UNDER THE SKIN FOR IV TREATMENT) WAS DEFECTIVE AND PRODUCED LEAKING IN THE TUBING APPROXIMATELY 10 CM FROM THE CAPSULE. THE PATIENT WAS REPORTED TO EXPERIENCE DISCOMFORT AND PAIN AFTER THE INFUSION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21399105 ↗
• MalfunctionFeb 18, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE PAC SYSTEM (A CAPSULE THAT IS PLACED UNDER THE SKIN FOR IV TREATMENT) WAS DEFECTIVE AND PRODUCED LEAKING IN THE TUBING APPROXIMATELY 10 CM FROM THE CAPSULE. THE PATIENT WAS REPORTED TO EXPERIENCE DISCOMFORT AND PAIN AFTER THE INFUSION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21392902 ↗
• MalfunctionFeb 18, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE PAC SYSTEM (A CAPSULE THAT IS PLACED UNDER THE SKIN FOR IV TREATMENT) WAS DEFECTIVE AND PRODUCED LEAKING IN THE TUBING APPROXIMATELY 10 CM FROM THE CAPSULE. THE PATIENT WAS REPORTED TO EXPERIENCE DISCOMFORT AND PAIN AFTER THE INFUSION

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21392734 ↗
• MalfunctionFeb 13, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE PAC SYSTEM (A CAPSULE THAT IS PLACED UNDER THE SKIN FOR IV TREATMENT) WAS DEFECTIVE AND PRODUCED LEAKING IN THE TUBING APPROXIMATELY 10 CM FROM THE CAPSULE. THE PATIENT WAS REPORTED TO EXPERIENCE DISCOMFORT AND PAIN AFTER THE INFUSION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21379769 ↗
• MalfunctionFeb 10, 2025Separation Problem; Separation Problem

  IT WAS REPORTED THAT DURING THE CATHETERIZATION PROCESS THE TIP OF THE PUNCTURE SHEATH WAS SPLIT WHEN IT WAS BEING INSERTED. THERE WERE NO PATIENT HARM OR ADVERSE EVENTS REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21343524 ↗
• InjuryFeb 7, 2025Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

  IT WAS REPORTED THAT THERE WAS AN EXTRAVASATION DUE TO A DOUBLE TEAR, 10CM FROM THE PORT CHAMBER. THE PATIENT DEVELOPED SUB CLAVICULAR SWELLING, PLUS INFECTION AS PART OF THE FOLLOW-UP, SMALL EXTRAVASATION, NOT EXCLUDING THE CHEMOTHERAPY. THE FIRST SYMPTOM DEVELOPED ON (B)(6) 2024. THE EVENT OCCURRED DURING CHEMOTHERAPY AND THE PRODUCT WAS HANDLED BY THE PERSONNEL. THE PORT WAS CHANGED ON (B)(6) 2025 AND ANOTHER ONE WAS INSTALLED FOR THE RESIDUAL INFECTION. AS A RESULT OF THE INCIDENT, THE PATIENT WAS SUBJECTED TO TOPICAL OPEN WOUND TREATMENT, PORT REMOVAL, AB-THERAPY AND WAS ADMITTED TO THE (B)(6) HOSPITAL BETWEEN (B)(6) 2025. THE EVENT CAUSED A DELAY IN THE PALLIATIVE CHEMOTHERAPY.

  Patient problems: Extravasation; Localized Skin Lesion

  MAUDE report 21333388 ↗
• MalfunctionDec 26, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT DURING SURGERY A FOREIGN MATTER WAS FOUND INSIDE THE LOCK PORT. THERE WAS NO PATIENT HARM/ADVERSE EVENT REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21021175 ↗
• InjuryDec 6, 2024Unexpected Therapeutic Results; Unexpected Therapeutic Results

  IT IS STATED THAT THE PATIENT UNDERWENT AN ULTRASOUND-GUIDED RIGHT INTERNAL JUGULAR VEIN CATHETERIZATION AND RIGHT CHEST WALL INFUSION PORT PLACEMENT, AND ON THE THIRD DAY AFTER SURGERY, THERE WAS LOCAL SWELLING AND PAIN OCCURRED AT THE INCISION OF THE PART BODY. THE PATIENT WAS RE-INCISED, AND THE WOUNDS WERE RE-CLEANED AND THEN UNDERWENT PORT IMPLANTATION TO IMPLANT A NEW ONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20866197 ↗
• InjuryOct 9, 2023Material Fragmentation; Material Fragmentation

  ADDITIONAL INFORMATION RECEIVED BY EMAIL, THE PATIENT RECEIVED TREATMENT WITH PACLITAXEL, ADRAIMYCIN AND CYCLOPHOSPHAMIDE AND CURRENTLY CARRIES ANOTHER PORT-A-CATH.

  Patient problems: Foreign Body In Patient

  MAUDE report 17898979 ↗
• InjurySep 18, 2023Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  IT WAS REPORTED THAT THE PATIENT HAD AN IMPLANTABLE PORT PLACED ON (B)(6) 2019. ON (B)(6) 2023, AT THE CANCER CENTER, THE PORT WAS ACCESSED WITH NO BLOOD RETURN. TPA INJECTED DUE TO POSSIBLE CLOT BY INTAKE NURSE. AFTER 1 HOUR BLOOD RETURN NOT OBTAINED. ON (B)(6) 2023, "IVR-IR CONTRAST INJECTION CHECK CV ACCESS PERFORMED". CUSTOMER STATED "THERE WAS AT LEAST PARTIAL DISCONTINUITY OF THE CATHETER TUBING AT THE CONNECTING WITH THE PORT POCKET, WITH SPILLAGE OF CONTRAST INTO THE SUBCUTANEOUS TISSUES OF THE LEFT NECK. CONTRAST DID OPACITY THE ENTIRE LENGTH OF THE CATHETER." ON (B)(6) 2023, DUE TO THE MALFUNCTION AND DISCONTINUITY OF THE PORT, THE PORT WAS REMOVED IN A SURGICAL ONCOLOGY OUTPATIENT OFFICE. THE PATIENT WAS A 65-YEAR-OLD FEMALE WITH METASTIC MELANOMA FOUND TO HAVE A NONFUNCTIONAL PORT. STUDY WAS FOUND TO HAVE THE CATHETER DISCONNECTED FROM THE TIP OF THE PORT. PATIENT STATUS POST TREATMENT: PATIENT SUPINE, THE LEFT CHEST SKIN WAS PREPPED AND DRAPED IN STERILE FASHION. THE SKIN WAS ANESTHETIZED WITH 1% LIDOCAINE WITH EPINEPHRINE. AN INCISION THROUGH THE PRIOR INSERTION SITE WAS MADE WITH A SCALPEL BLADE. THE MEDIPORT WAS SHARPLY DISSECTED AND REMOVED GROSSLY INTACT. THE COUN

  Patient problems: Insufficient Information

  MAUDE report 17769451 ↗
• InjuryAug 9, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT HAD A CT SCAN WITH CONTRAST UTILIZING PORT A CATH II POWERPAC WITHOUT NOTED DIFFICULTY. ON (B)(6) 2023, PATIENT VISITED ONCOLOGY FOR LAB DRAW. THE REGISTERED NURSE (RN) WAS UNABLE TO OBTAIN BLOOD RETURN LABS. IR CONTRAST INJECTION, IVR AND CHEST X-RAY PERFORMED AND INDICATED DISLODGED PORT A CATH WITH THE TUBING IN THE R ATRIUM AND R VENTRICLE. PATIENT WAS TRANSFERRED TO ANOTHER HEALTHCARE FACILITY FOR SURGICAL REMOVAL. ADVERSE PATIENT EFFECTS ARE UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 17494337 ↗
• InjuryAug 9, 2023Detachment of Device or Device Component; Separation Problem; Detachment of Device or Device Component; Separation Problem

  IT WAS REPORTED THAT A PATIENT HAD A PORT A CATH PLACED ON (B)(6)2020. ON (B)(6)2023 MEDICAL FACILITY NOTES INDICATES THE FOLLOWING: PATIENT FOR CVC MEDIPORT FLUSH IN FAST TRACK. PORT IN R CHEST ACCESSED WITHOUT DIFFICULTY, NO BLOOD RETURN AFTER 1 CC FLUSH, FLUSHED WITH 4 CC OF NSS AND AREA ABOVE PORT ACCESS BECAME EDEMATOUS AND COOL TO TOUCH?. PATIENT DENIED PAIN WITH FLUSHING, BUT SLIGHT DISCOMFORT WITH PALPITATION OF AREA. CHARGE RN AND NP NOTIFIED FOR ASSESSMENT. STAT CHEST X-RAY WAS ORDERED, AND THE PORT DE-ACCESSED. CHEST X-RAY RESULTS: THERE IS A RIGHT SIDED MEDIPORT. THERE IS A SEPARATION OF THE CATHETER FROM THE PORT MEASURING 1.1 CM. THERE IS NO DISTAL MIGRATION OF THE CATHETER. THE CATHETER TIP OVERLIES THE SVC. PATIENT WAS TRANSFERRED TO THE ED WHERE THE PORT A CATH WAS REMOVED BEDSIDE BY THE SURGEON. ADVERSE PATIENT EFFECTS ARE UNKNOWN.

  Patient problems: Discomfort

  MAUDE report 17494254 ↗
• InjuryAug 9, 2023Detachment of Device or Device Component; Separation Problem; Detachment of Device or Device Component; Separation Problem

  IT WAS REPORTED THAT A PATIENT HAD A PORT A CATH PLACED ON (B)(6) 2019. ON (B)(6) 2023 A CHEST X-RAY WAS COMPLETED DUE TO DEVICE DIFFICULTIES WHICH NOTED "RIGHT SIDED MEDIPORT CATHETER IS NOTED". THE TUBE HAS SEPARATED FROM THE PORT AND MIGRATED APPROXIMATELY 5 CM. THE TIP WAS NOW IN THE REGION OF THE CAVOATRIAL JUNCTION WERE PREVIOUSLY IT WAS OVERLYING THE SVC. VASCULAR SURGERY CONSULT WAS RECOMMENDED, PATIENT TRANSFERRED TO THE ED WHERE THE SURGEON REMOVED THE DEVICE BEDSIDE. ADVERSE PATIENT EFFECTS ARE UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 17494214 ↗

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; 2.