Deltec 21-2947-24Recalls & reported problems
Icu Medical, Inc. · Class 2
Quick summary
This ICU Medical implanted venous access port and its tubing are used to deliver IV drugs and draw blood. The 27 reports mostly describe the line being blocked or clogged so fluid or medication cannot pass, leaking or bleeding at the connection, and needles bending or breaking during flushing and maintenance. No deaths and1 injury were reported; most events needed the port replaced or re-punctured to restore flow.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 28
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 10610586016776), received between May 19, 2022 and Sep 18, 2026 — classified as 1 injury, 27 malfunctions.
The most frequently reported specific device problem is “Complete Blockage” (9 reports).
1 other recall cover devices cleared under the same FDA submission (K870866); 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.
Reports received per month
Most reported problems
Device problems
- Complete Blockage9
- Obstruction of Flow6
- Fluid/Blood Leak5
- Break3
- Blocked Connection2
- Disconnection2
- Leak/Splash2
- Crack1
Patient problems
- No Clinical Signs, Symptoms or Conditions27
- Failure of Implant1
Recent adverse event reports
The 25 most recent of 28 reports, 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 ↗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 ↗MalfunctionMar 12, 2026Complete Blockage
IT WAS STATED IN THE REPORT THAT THERE WAS NO BLOOD RETURN UPON ASPIRATION. UPON REMOVING THE TROCAR, IT WAS FOUND THAT THE NEEDLE SHAFT WAS BENT AND THE NEEDLE TIP WAS CURVED. THERE WAS A PATIENT INVOLVEMENT AND NO HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24586333 ↗MalfunctionFeb 4, 2026Complete Blockage; Obstruction of Flow
IT WAS REPORTED THAT THE SERVICE DECLARES AN EPISODE OF DYSPNEA AT THE ARTIFICIAL NOSE, PARTIALLY RELIEVED AFTER ASPIRATION, WITH A TRANSIENT IMPROVEMENT IN VENTILATION. SECONDARILY, OCCURRENCE OF MAJOR DYSPNEA WITH VERY LOW VENTILATORY VOLUMES. IT WAS FOUND THAT THE CANNULA WAS ALMOST COMPLETELY OBSTRUCTED. A CANNULA CHANGE WAS CARRIED OUT URGENTLY FOR OBSTRUCTION, ALLOWING RAPID CLINICAL IMPROVEMENT. THERE WAS PATIENT INVOLVEMENT. THE PATIENT PRESENTED WITH SEVERE DYSPNEA RELATED TO AN ALMOST COMPLETE OBSTRUCTION OF THE CANNULA. THE PATIENT RECEIVED MEDICAL TREATMENT. THE MEDICAL TREATMENT CONSISTED OF AN URGENT INTERVENTION WITH CANNULA REPLACEMENT AND RESPIRATORY MANAGEMENT. NO SPECIFIC DRUGS HAVE BEEN REPORTED AT THIS STAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24258199 ↗MalfunctionFeb 4, 2026Leak/Splash
IT WAS STATED IN THE REPORT THAT A PRODUCT LEAKAGE IN THE HEMATOLOGY DEPARTMENT DURING USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24258182 ↗MalfunctionDec 3, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT NURSE PERFORMED A PORT NEEDLE INSERTION PROCEDURE. IT WAS FOUND THAT THERE WAS SLIGHT BLEEDING FROM THE IMPLANTED VENOUS ACCESS SYSTEM. AFTER WIPING WITH A COTTON SWAB, THE BLEEDING PERSISTED. THE NURSE EXPLAINED THE SITUATION TO THE PATIENT, REMOVED THE NEEDLE, REPLACED IT WITH A NEW IMPLANTED VENOUS ACCESS SYSTEM, AND PERFORMED THE PUNCTURE AGAIN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23710440 ↗MalfunctionNov 12, 2025Obstruction of Flow; Obstruction of Flow
IT WAS REPORTED THAT A NURSE WAS PREPARING TO PERFORM MAINTENANCE ON A PATIENT'S INFUSION PORT. WHILE PRIMING, SHE SUDDENLY STOPPED USING IT AFTER DISCOVERING THAT IT WAS CLOGGED. SHE THEN REPLACED IT WITH A NEW IMPLANTABLE INTRAVENOUS DRUG DELIVERY SYSTEM. NO SIMILAR ADVERSE EVENTS WERE OBSERVED, AND NO HARM WAS CAUSED TO THE PATIENT. THERE WAS PATIENT INVOLVEMENT, BUT NO HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23529635 ↗MalfunctionJun 13, 2025Blocked Connection; Blocked Connection
IT WAS REPORTED THAT THE TUBING WAS BLOCKED AND COULD NOT INFUSE. THERE WAS NO REPORT OF ADVERSE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22204139 ↗MalfunctionJun 9, 2025Complete Blockage; Complete Blockage
IT WAS REPORTED THAT WHEN THE NEEDLE WAS CONNECTED TO THE SYRINGE FOR PRIMING, THERE WAS RESISTANCE AND IT COULD NOT BE PUSHED. THE EVENT OCCURRED DURING PRIMING AND NO PATIENT HARM WAS REPORTED. IT WAS STATED IN THE REPORT THAT THE PATIENT, A 51-YEAR-OLD FEMALE BORN ON (B)(6) 1973, WAS GIVEN INFUSION THERAPY ACCORDING TO THE DOCTOR'S INSTRUCTIONS, AND WHEN THE NEEDLE WAS CONNECTED TO THE SYRINGE FOR PRIMING, IT WAS FOUND THAT THERE WAS RESISTANCE AND COULD NOT BE PUSHED. THE EVENT OCCURRED DURING PRIMING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22167640 ↗MalfunctionJun 4, 2025Complete Blockage; Complete Blockage
IT WAS REPORTED THAT THE INTERFACE STRUCTURE OF THE INFUSION PORT OF THE IMPLANTED INTRAVENOUS DRUG DELIVERY SYSTEM WAS BLOCKED AND WAS IMMEDIATELY REPLACED WITH A NEW IMPLANTED INTRAVENOUS DRUG DELIVERY SYSTEM TO CONTINUE TREATMENT, DELAYING THE TREATMENT TIME OF THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22142381 ↗MalfunctionMay 15, 2025Complete Blockage; Complete Blockage
IT WAS REPORTED THAT THE INTERFACE STRUCTURE OF THE INFUSION PORT OF THE IMPLANTED INTRAVENOUS DRUG DELIVERY SYSTEM WAS BLOCKED AND WAS IMMEDIATELY REPLACED WITH A NEW IMPLANTED INTRAVENOUS DRUG DELIVERY SYSTEM TO CONTINUE TREATMENT, DELAYING THE TREATMENT TIME OF THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22031117 ↗MalfunctionMay 12, 2025Flushing Problem; Flushing Problem
IT WAS REPORTED THAT THE PATIENT FLUSHED THE PORT IN THE CATHETERIZATION CLINIC. WHEN OPERATING THE SALTWATER EXHAUST, IT WAS FOUND THAT THE EXHAUST COULD NOT BE DONE. THE NEEDLE WAS REPLACED WITH A NEW ONE, AND NO SIMILAR ADVERSE EVENTS OCCURRED, AND THERE WAS NO PATIENT HARM/ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22002932 ↗MalfunctionMar 21, 2025Break; Break
IT WAS REPORTED THE CATHETER FAILED AT THE INFUSION PORT. THE PATIENT WAS IMPLANTED WITH AN INFUSION PORT UNDER THE RIGHT COLLARBONE DUE TO OVARIAN CANCER. LATER, DUE TO A RECURRENCE OF CANCER, THE INFUSION PORT WAS FOUND TO BE UNUSABLE AT THE HOSPITAL. SCREENING REVEALED THAT THE CATHETER HAD DETACHED, AND IT WAS REMOVED THROUGH VASCULAR INTERVENTION SURGERY AT THE INTERVENTIONAL DEPARTMENT IN THE EVENING. IT WAS DISCOVERED THAT THE CATHETER HAD DETACHED AT THE LATCH CONNECTION. THERE WAS NO HARM OR ADVERSE EFFECTS REPORTED AS A RESULT OF THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21662461 ↗MalfunctionMar 20, 2025Complete Blockage; Complete Blockage
IT WAS REPORTED THAT NURSE FROM THE NASOPHARYNGEAL/CHEST TUMOR RADIOTHERAPY DEPARTMENT WAS PREPARING TO INSTALL AN IMPLANTABLE INTRAVENOUS DRUG DELIVERY SYSTEM FOR THE PATIENT. UPON PRE-CHARGING, SHE DISCOVERED A NEEDLE BLOCKAGE, PREVENTING THE PRE-FILLED FLUID FROM PASSING THROUGH PIPES, AND SHE IMMEDIATELY DISCONTINUED IT. THERE WAS UNKNOWN PATIENT HARM OR ADVERSE EFFECTS REPORTED AS A RESULT OF THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21657913 ↗MalfunctionJan 6, 2025Crack; Leak/Splash; Crack; Leak/Splash
IT WAS REPORTED THAT UPON INSERTING THE PORT TO THE PATIENT, THE INFUSION CONNECTOR KEPT LEAKING WHEN PRIMING THE SYRINGE. UPON INSPECTION, IT WAS FOUND THAT THE INFUSION CONNECTOR WAS CRUSHED AND CRACKED AND COULD NOT BE USED AND WAS THEN REPLACED WITH A NEW ONE. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21079889 ↗MalfunctionNov 19, 2024Complete Blockage; Complete Blockage
IT WAS REPORTED THAT DURING NORMAL CLINICAL USE AT THE HOSPITAL, IT WAS FOUND THAT THE NEEDLE HAD A BLOCKAGE AND COULDN¿T BE USED. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT HARM/ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20724998 ↗MalfunctionOct 7, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE INFUSION WAS LEAKING. UPON INSPECTION IT WAS FOUND THAT THERE WAS A CRACK IN THE HEPARIN CAP ON THE CONNECTING LOCK PART OF THE DRUG DELIVERY DEVICE. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT HARM/ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20389789 ↗MalfunctionAug 22, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT WHEN THE PORT NEEDLE WAS PRIMING, IT WAS FOUND THAT THE HEPARIN CAP CONNECTOR OF THE PORT NEEDLE WAS LEAKING. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT HARM/ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20039280 ↗MalfunctionJul 12, 2024Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT DURING USE NEEDLE TIP BARBS WERE FOUND. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19735774 ↗MalfunctionMay 23, 2024Complete Blockage; Complete Blockage
IT WAS REPORTED THAT THE IMPLANTABLE INTRAVENOUS DRUG DELIVERY SYSTEM NEEDLE WAS OBSTRUCTED AFTER FLUSHING THE TUBE, AND IT COULD NOT BE PUSHED WHEN THE PRESSURE WAS BEING PUSHED. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19380716 ↗MalfunctionMay 3, 2024Complete Blockage; Packaging Problem; Complete Blockage; Packaging Problem
IT WAS REPORTED THAT BEFORE THE PATIENT WAS GIVEN THE INFUSION PORT MAINTENANCE, THE IMPLANTED INTRAVENOUS DRUG DELIVERY SYSTEM WAS VENTED, AND THE DRUG SOLUTION COULD NOT BE DISCHARGED. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19243441 ↗MalfunctionJan 26, 2024Disconnection; Disconnection
IT WAS REPORTED THAT AFTER MAINTENANCE ON THE INFUSION PORT, THE HEPARIN CAP WAS FOUND DISCONNECTED WHEN THE STERILE, IMPLANTABLE, INTRAVENOUS DRUG DELIVERY SYSTEM WAS OPENED. THE POSITIVE PRESSURE CONNECTOR WAS IMMEDIATELY CONNECTED IN A STERILE ENVIRONMENT, AND THE INFUSION PORT WAS MAINTAINED AGAIN. THERE WAS PATIENT INVOLVEMENT, BUT NO HARM ADVERSE EVENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18588980 ↗MalfunctionApr 17, 2023Break; Fluid/Blood Leak; Break; Fluid/Blood Leak
IT WAS REPORTED THAT ON THE THIRD DAY OF AN INFUSION, THE PATIENT FELT A LEAK IN THE INFUSION, AND SAW THAT THE EXTENSION TUBE WAS BROKEN, THE NURSE TURNED OFF THE INFUSION IN TIME AND REMOVED THE NEEDLE, AND REPLACED IT WITH A NEW NEEDLE TO CONTINUE THE INFUSION. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16755749 ↗MalfunctionSep 9, 2022Obstruction of Flow; Obstruction of Flow
IT WAS REPORTED THAT, DURING THE MAINTENANCE OF THE INFUSION PORT, WHEN REMOVING THE PACKAGE OF THE IMPLANTABLE INTRAVENOUS DRUG DELIVERY SYSTEM AND GIVING EXHAUST, IT WAS FOUND THAT THE NORMAL EXHAUST CANNOT BE CARRIED OUT. THE HOSPITAL ANALYZED THE CAUSE OF THE INCIDENT AS SUSPECTED NEEDLE BLOCKAGE. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15397418 ↗MalfunctionSep 9, 2022Blocked Connection; Blocked Connection
IT WAS REPORTED THAT, DURING THE MAINTENANCE PROCESS OF THE INFUSION PORT, WHEN THE IMPLANTABLE INTRAVENOUS DRUG DELIVERY SYSTEM PACKAGE WAS REMOVED TO GIVE EXHAUST, IT WAS FOUND THAT IT COULD NOT BE EXHAUSTED NORMALLY. OTHER LOOPS ON THE IMPLANTED INTRAVENOUS DRUG DELIVERY SYSTEM WERE CHECKED. THERE IS NO PROBLEM WITH THE JOINTS, AND THE NEEDLE IS SUSPECTED TO BE CLOGGED. IT WAS REPLACED WITH A NEW IMPLANTABLE DRUG DELIVERY SYSTEM WITH NO ISSUES. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15397416 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K870866. One submission often covers many models, so check the product and lot details in each record.
- Z-0189-2020 · Jul 8, 2019 · TerminatedGRIPPER Needles sold individually. Labeled as the following item descriptions: 1. NDL, GRIPPER, 22G X 1" (25MM), 12/BX; 2. NDL, GRIPPER, 22G X 1.25" (32MM), 12/BX; 3. NDL
Other Set, administration, intravascular devices
- Autosoft XC 1001680Unomedical A/S · Set, Administration, Intravascular1 death16,105 reports
- Autosoft90™ 1002817Unomedical A/S · Set, Administration, Intravascular1 recall11,907 reports
- Minimed™ Quick-set™ MMT-399AUnomedical A/S · Set, Administration, Intravascular9 deaths8,669 reports
- Medtronic Extended MMT-431AUnomedical A/S · Set, Administration, Intravascular3 deaths8,574 reports
- MiniMed™ Mio™ Advance MMT-242AUnomedical A/S · Set, Administration, Intravascular15 deaths8,164 reports
- CADD 21-7302-24Icu Medical, Inc. · Set, administration, intravascular4 recalls1 death4,657 reports
- Autosoft XC 1001681Unomedical A/S · Set, Administration, Intravascular1 death4,216 reports
- Minimed™ Quick-set™ MMT-397AUnomedical A/S · Set, Administration, Intravascular19 deaths4,134 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.