DeltecRecalls & reported problems across all models

We found 97 models of Deltec by Icu Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 637 adverse event reports in the FDA's MAUDE database, received between May 23, 2016 and Sep 18, 2026 — classified as 2 deaths, 175 injuries, 460 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (103 reports).

12 FDA recall records name at least one of these models by its device identifier, 12 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Deltec recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

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-1288-2025 · Root cause: Process control · Recall details · FDA record ↗

2. 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-1287-2025 · Root cause: Process control · Recall details · FDA record ↗

3. 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-1286-2025 · Root cause: Process control · Recall details · FDA record ↗

4. 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-1285-2025 · Root cause: Process control · Recall details · FDA record ↗

5. 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-1284-2025 · Root cause: Process control · Recall details · FDA record ↗

6. 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-1283-2025 · Root cause: Process control · Recall details · FDA record ↗

7. 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-1282-2025 · Root cause: Process control · Recall details · FDA record ↗

8. 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 · Recall details · FDA record ↗

9. 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 · Recall details · FDA record ↗

10. 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-1279-2025 · Root cause: Process control · Recall details · FDA record ↗

11. 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-1278-2025 · Root cause: Process control · Recall details · FDA record ↗

12. 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-1277-2025 · Root cause: Process control · Recall details · FDA record ↗

Most reported Deltec problems

Deltec models

97 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Deltec 21-4155-24

  PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
  1 recall13 reports
• Deltec 21-4153-24

  PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
  1 recall8 reports
• Deltec 21-4183-24

  PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
  1 recall3 reports
• Deltec 21-4187-24

  PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
  1 recall3 reports
• Deltec 21-4152-24

  PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
  1 recall1 report
• Deltec 21-4150-24

  PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
  1 recall0 reports
• Deltec 21-4151-24

  PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
  1 recall0 reports
• Deltec 21-4165-24

  PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
  1 recall0 reports
• Deltec 21-4171-24

  PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
  1 recall0 reports
• Deltec 21-4172-24

  PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
  1 recall0 reports
• Deltec 21-4173-24

  PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
  1 recall0 reports
• Deltec 21-4182-24

  PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
  1 recall0 reports
• Deltec 21-4483-24

  PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
  42 reports
• Deltec 21-2767-24

  Set, administration, intravascular
  41 reports
• Deltec 21-3465-24

  Set, administration, intravascular
  37 reports
• Deltec 21-2947-24

  Set, administration, intravascular
  28 reports
• Deltec 21-4083-24

  PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
  28 reports
• Deltec 21-2766-24

  Set, administration, intravascular
  28 reports
• Deltec 21-4475-24

  PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
  27 reports
• Deltec 21-2965-24

  Set, administration, intravascular
  24 reports
• Deltec 21-2764-24

  Set, administration, intravascular
  21 reports
• Deltec 21-3367-24

  Set, administration, intravascular
  21 reports
• Deltec 21-4455-24

  PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
  1 death20 reports
• Deltec 21-4055-24

  PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
  19 reports
• Deltec 21-2770-24

  Needle, hypodermic, single lumen
  16 reports
• Deltec 21-3468-24

  Set, administration, intravascular
  15 reports
• Deltec 21-2961-24

  Set, administration, intravascular
  13 reports
• Deltec 21-2966-24

  Set, administration, intravascular
  12 reports
• Deltec 21-4471-24

  PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
  12 reports
• Deltec 21-3271-24

  Set, administration, intravascular
  9 reports
• Deltec 21-2733-24

  Set, administration, intravascular
  8 reports
• Deltec 21-3256-24

  Set, administration, intravascular
  8 reports
• Deltec 21-4591-24

  PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
  7 reports
• Deltec 21-2762-24

  Set, administration, intravascular
  7 reports
• Deltec 21-2865-24

  Set, administration, intravascular
  7 reports
• Deltec 21-3251-24

  Set, administration, intravascular
  7 reports
• Deltec 21-4477-24

  PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
  7 reports
• Deltec 21-4071-24

  PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
  6 reports
• Deltec 21-4590-24

  PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
  6 reports
• Deltec 21-2968-24

  Set, administration, intravascular
  6 reports
• Deltec 21-2960-24

  Set, administration, intravascular
  5 reports
• Deltec 21-4454-24

  PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
  5 reports
• Deltec 21-4485-24

  PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
  5 reports
• Deltec 21-3369-24

  Set, administration, intravascular
  5 reports
• Deltec 21-4474-24

  PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
  5 reports
• Deltec 21-2714-24

  Set, administration, intravascular
  4 reports
• Deltec 21-2734-24

  Set, administration, intravascular
  4 reports
• Deltec 21-2735-24

  Set, administration, intravascular
  4 reports
• Deltec 21-2939-24

  Set, administration, intravascular
  1 death4 reports
• Deltec 21-2768-24

  Set, administration, intravascular
  4 reports
• Deltec 21-2860-24

  Set, administration, intravascular
  4 reports
• Deltec 21-3276-24

  Set, administration, intravascular
  4 reports
• Deltec 21-4453-24

  PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
  4 reports
• Deltec 21-2715-24

  Set, administration, intravascular
  3 reports
• Deltec 21-3277-24

  Set, administration, intravascular
  3 reports
• Deltec 21-4425-24

  PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
  3 reports
• Deltec 21-4452-24

  PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
  3 reports
• Deltec 21-3368-24

  Set, administration, intravascular
  3 reports
• Deltec 21-4437-24

  PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
  2 reports
• Deltec 21-4052-24

  PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
  2 reports
• Deltec 21-4009-24

  PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
  2 reports
• Deltec 21-4025-24

  PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
  2 reports
• Deltec 21-2760-24

  Set, administration, intravascular
  2 reports
• Deltec 21-2861-24

  Set, administration, intravascular
  2 reports
• Deltec 21-2863-24

  Set, administration, intravascular
  2 reports
• Deltec 21-2864-24

  Set, administration, intravascular
  2 reports
• Deltec 21-2868-24

  Set, administration, intravascular
  2 reports
• Deltec 21-3257-24

  Set, administration, intravascular
  2 reports
• Deltec 21-3261-24

  Set, administration, intravascular
  2 reports
• Deltec 21-4473-24

  PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
  2 reports
• Deltec 21-8466-24

  PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
  2 reports
• Deltec 21-3362-24

  Set, administration, intravascular
  2 reports
• Deltec 21-3364-24

  Set, administration, intravascular
  2 reports
• Deltec 21-3466-24

  Set, administration, intravascular
  2 reports
• Deltec 21-2005-24

  PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
  1 report
• Deltec 21-4170-24

  PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
  1 report
• Deltec 21-2718-24

  Set, administration, intravascular
  1 report
• Deltec 21-2720-24

  Set, administration, intravascular
  1 report
• Deltec 21-2948-24

  Set, administration, intravascular
  1 report
• Deltec 21-2737-24

  Set, administration, intravascular
  1 report
• Deltec 21-2938-24

  Set, administration, intravascular
  1 report
• Deltec 21-2736-24

  Set, administration, intravascular
  1 report
• Deltec 21-4051-24

  PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
  1 report
• Deltec 21-4063-24

  PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
  1 report
• Deltec 21-4003-24

  PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
  1 report
• Deltec 21-4023-24

  PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
  1 report
• Deltec 21-4034-24

  PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
  1 report
• Deltec 21-4035-24

  PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
  1 report
• Deltec 21-2340-24

  INTRODUCER, CATHETER
  1 report
• Deltec 21-2765-24

  Set, administration, intravascular
  1 report
• Deltec 21-2866-24

  Set, administration, intravascular
  1 report
• Deltec 21-3260-24

  Set, administration, intravascular
  1 report
• Deltec 21-4436-24

  PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
  1 report
• Deltec 21-4482-24

  PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
  1 report
• Deltec 21-3467-24

  Set, administration, intravascular
  1 report
• Deltec 21-4069-24

  PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
  1 report
• Deltec 21-4476-24

  PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
  1 report

Recent Deltec adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2026Obstruction of Flow

  It was stated in the report that the doctor found the tube was blocked and couldn't push it through.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50818222 ↗
• MalfunctionSep 11, 2026Fluid/Blood Leak; Detachment of Device or Device Component

  Patient problems: Extravasation; Pain; Swelling/ Edema

  MAUDE report 50741329 ↗
• MalfunctionSep 10, 2026Patient Device Interaction Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50719114 ↗
• MalfunctionSep 8, 2026Obstruction of Flow

  It was reported that during infusion with Deltec Gripper Plus Needle, the gripper was clamped and did not infuse. There was patient involvement and no patient harm.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50668054 ↗
• MalfunctionSep 7, 2026Obstruction of Flow

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50657262 ↗
• MalfunctionSep 7, 2026Obstruction of Flow

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50652286 ↗
• MalfunctionJul 3, 2026Fluid/Blood Leak; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PORT NEEDLE COULDN'T BE INJECTED PROPERLY. DURING NEEDLE REMOVAL, IT WAS SUSPECTED THAT THE SAFETY DEVICE ACTIVATED DUE TO DAMAGE TO THE MAIN BODY. THE PATIENT WAS RECEIVING AN INFUSION THROUGH AN IMPLANTABLE INTRAVENOUS DRUG DELIVERY SYSTEM. AFTER 30 MINUTES OF INFUSION, THE NEEDLE REBOUNDED AND THE RIGHT-ANGLE NEEDLE BECAME DISLODGED, RESULTING IN PARTIAL EXTRAVASATION OF ONDANSETRON HYDROCHLORIDE INJECTION. A LOCAL SODIUM SULFATE COLD COMPRESS WAS APPLIED, AND A CHEST X-RAY WAS REPEATED TO CONFIRM THE PORT POSITION. THE EXTRAVASATION MAY REDUCE TREATMENT EFFECTIVENESS, INCREASE THE RISK OF INFECTION, CAUSE PATIENT ANXIETY, REQUIRE PORT CATHETER REMOVAL AND REIMPLANTATION, AND INCREASE PATIENT DISCOMFORT. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25707460 ↗
• MalfunctionJun 24, 2026Obstruction of Flow

  IT WAS REPORTED THAT WHEN THE NURSE INTENDED TO MAINTAIN THE INFUSION FOR THE PATIENT AND CHECK THE PATENCY AND THE INTEGRITY OF THE IMPLANTED INTRAVENOUS DRUG DELIVERY SYSTEM, FOUND THAT IT CANNOT BE PROPERLY FLUSHED WITH THE MATERIAL, SO NURSE IMMEDIATELY REPLACED THE IMPLANTABLE INTRAVENOUS INFUSION SYSTEM. THERE WAS A PATIENT INVOLVEMENT AND THERE WERE NO ADDITIONAL ADVERSE CONSEQUENCES. HOWEVER, IF THIS FAILURE MODE REOCCURS DURING INFUSION, IT WILL INTERRUPT THERAPY AND IMPACT PATIENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25611184 ↗
• MalfunctionJun 23, 2026Contamination

  IT WAS REPORTED THAT DURING NEEDLE INSERTION, THE PORT-A-CATH IMPLANTABLE ACCESS PORT, A WHITE FLAKE WAS NOTICED DURING ASPIRATION ON THE VENOUS PORT AND NO LONGER USED. THE PATIENT REQUIRED REPLACEMENT OF THE VENOUS PORT AND UNDERWENT ADDITIONAL SURGERY IN WHICH THESE FLAKES WERE FOUND. THERE WAS PATIENT INVOLVEMENT; HOWEVER, UNKNOWN HARM/ADVERSE EVENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25598031 ↗
• MalfunctionJun 12, 2026Detachment of Device or Device Component

  AN EVENT INVOLVED A DELTEC GRIPPER PLUS NEEDLE WHERE IT WAS STATED THAT DURING THE REMOVAL OF THE DEVICE USED FOR ADMINISTERING ANTI-CANCER THERAPY, FROM THE PATIENT¿S PORT-A-CATH, A TAB FUNCTIONING AS THE PIVOT MECHANISM FOR NEEDLE ROTATION FAILED. THIS MALFUNCTION PREVENTED PROPER ENGAGEMENT WITH THE SAFETY SYSTEM AND RESULTED IN AN INJURY TO THE OPERATOR. THIS HAS THE POTENTIAL FOR EXPOSURE TO BLOODBORNE PATHOGENS. THERE WAS PATIENT INVOLVEMENT, AND UNKNOWN HARM REPORTED.

  Patient problems: Needle Stick/Puncture

  MAUDE report 25484770 ↗
• MalfunctionMay 21, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT A PATIENT ARRIVED AT THE PEDIATRIC EMERGENCY DEPARTMENT AT APPROXIMATELY 2030 WITH LEAKAGE OBSERVED FROM THE PORT TUBING WHILE A HOME BLINATUMOMAB INFUSION WAS RUNNING. THE LEAKAGE WAS IDENTIFIED AT THE BOTTOM OF THE PORT NEEDLE LINE BEFORE CONNECTION TO THE CHEMOTHERAPY ADAPTER, AND THE INFUSION WAS CLOSELY MONITORED AND SUBSEQUENTLY PAUSED AT APPROXIMATELY 2125 FOR PORT REACCESS. BLOOD RETURN WAS VERIFIED, AND BLINATUMOMAB WAS RESTARTED AT 2145 AT A RATE OF 5 ML PER HOUR BY S. MORRIS, RN, AND D. HOPKINS, RN. THE LEAKING PORT NEEDLE HAD BEEN PLACED AT THE OUTPATIENT CLINIC ON 20-APR-26, AND THE CLINIC NEEDLE WAS RETAINED WITH THIS REPORT. THERE WAS A PATIENT INVOLVEMENT WITH NO HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25243173 ↗
• MalfunctionMay 1, 2026Fluid/Blood Leak; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE SIDE PORT CAP DISCONNECTED DURING INFUSION. THERE WAS PATIENT INVOLVEMENT AND NO REPORTED HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25060385 ↗
• InjuryApr 24, 2026Migration

  A PRODUCT LIABILITY LAWSUIT WAS RECEIVED THROUGH A WATCH SERVICE. THE LAWSUIT ALLEGES THE FOLLOWING: ON OR ABOUT (B)(6) 2005, THE PATIENT¿S DELTEC LOW PROFILE PORT A CATH, ITEM NUMBER 21 4034 24 AND LOT NUMBER M21192, WAS EXPLANTED DUE TO A CATHETER COMPONENT OF THE IMPLANTED PORT HAVING FRACTURED AND EMBOLIZED, MIGRATED THROUGH THE HEART, AND LODGED IN THE LEFT DESCENDING PULMONARY ARTERY. THE DEVICE WAS IMPLANTED FOR THE PURPOSE OF ADMINISTERING CHEMOTHERAPY AS TREATMENT FOR BREAST CANCER ON OR ABOUT (B)(6) 2005.

  Patient problems: Device Embedded In Tissue or Plaque; Thrombosis/Thrombus

  MAUDE report 24983936 ↗
• 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 ↗
• MalfunctionApr 21, 2026Leak/Splash

  IT WAS STATED A CHEMICAL LEAK HAS OCCURRED. THE OPERATOR IS REQUESTING TO INVESTIGATE WHERE AND HOW IT IS LEAKING. THE EVENT OCCURRED DURING USE. THERE WAS NO REPORTED PATIENT HARM/ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24937908 ↗

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