Deltec 21-4455-24Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 10610586032707), received between Dec 12, 2017 and Jul 9, 2025 — classified as 1 death, 11 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (4 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• DeathJul 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ICU MEDICAL LEARNED OF A CIVIL LAWSUIT FILED IMPLICATING A PORT-A-CATH II, 21-4455-24, LOT 3829680. THE LAWSUIT ALLEGES THE FOLLOWING. THE PATIENT, (B)(6), UNDERWENT PLACEMENT OF A PORT IN THE LEFT CHEST, ON (B)(6) 2021 FOR VEIN ACCESS. THE PATIENT PRESENTED TO (B)(6) WITH SHORTNESS OF BREATH. DOCTORS DETERMINED SHE HAD AN INFECTION WITH ACCUMULATION OF FLUID IN THE LUNGS. THE PATIENT'S PORT WAS EXPLANTED IMMEDIATELY AFTER THIS DETERMINATION ON OR ABOUT (B)(6) 2023. THE PATIENT PASSED AWAY ON (B)(6) 2023.

  Patient problems: Cardiac Arrest

  MAUDE report 22459677 ↗
• MalfunctionMar 7, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THERE 4-6 CASES WITH LEAKING FROM THE CATHETER WHEN GIVING CHEMOTHERAPY. THE REPORTER STATED THAT DURING INFUSION OF THE DRUGS: BEVACIZUMAB, CALCIUM FOLINATE, FLUOROURACIL AND OXALIPALTIN, PATIENTS EXPERIENCE PAIN/ DISCOMFORT. DURING THE NEXT TREATMENT WITH THE SAME DRUGS, IT WAS NOT POSSIBLE TO GET AN INLET, AND A FLUOROSCOPY IS PERFORMED IN THE X-RAY DEPARTMENT WHICH SHOWS A DEFECTIVE PAC. THERE WAS AN ONCOLOGY DOCTOR WHO ATTENDED THE PATIENT DURING THE PROCEDURE AND A SURGICAL DOCTOR WHO REMOVED THE DEFECTIVE PAC DURING SURGERY.

  Patient problems: Discomfort; Pain

  MAUDE report 21553237 ↗
• MalfunctionFeb 18, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT DURING INFUSION OF CHEMOTHERAPY THE PATIENT FELT PAIN. X-RAY REVEALED A DEFECT OF THE PORT A CATHETER DEVICE. DURING INFUSION OF CHEMOTHERAPY THE PATIENT FELT PAIN. X-RAY REVEALED A DEFECT OF THE PORT A CATHETER. THERE WAS PATIENT INVOLVEMENT, NO SERIOUS INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21399006 ↗
• MalfunctionJan 2, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING TREATMENT OF A CANCER PATIENT, RESISTANCE AT THE INLET INTO THE DEVICE WAS FOUND. THIS REPORTEDLY LED TO THE PATIENT FEELING PAIN. THE DEVICE WAS TRANSILLUMINATED WITH CONTRAST AND A LEAK WAS FOUND IN THE HOSE. DUE TO THIS, THE DEVICE WAS SURGICALLY REMOVED AND REPLACED WITH A NEW ONE TO CONTINUE TREATMENT. AFTER THE REVISION OF THE DEVICE, NO PATIENT HARM WAS REPORTED.

  Patient problems: Pain

  MAUDE report 21061044 ↗
• MalfunctionNov 14, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE PATIENT HAD A LOT OF IRRITATION IN CONNECTION WITH INFUSION OF CHEMOTHERAPY ON PORT A CATH. THE PORT A CATH WAS DISCONTINUED AND WHEN THE NURSE TRIED TO SPRAY WATER THROUGH THE CATHETER A CLEAR LEAK WAS SEEN IN THE CATHETER APPROX. 10CM FROM THE PORT. THE PORT A CATH WAS REMOVED FROM THE PATIENT. CHEMOTHERAPY HAS BEEN GIVEN ON THE PORT A CATH BUT IT HAS BEEN CLEANED AND IS AVAILABLE FOR EXAMINATION. THE CASE HAS BEEN ESTABLISHED AS AN ACCIDENTAL INCIDENT AT THE HOSPITAL. THERE WAS PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20683024 ↗
• MalfunctionSep 24, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE INPUT WAS DELIVERED FOR SURGERY (7.8FR WAS REQUESTED), INSIDE THE PAVILION THEY OPENED IT AND THE DOCTOR INSTALLED IT, WHEN HE HAD THE DEVICE, HE NOTICED THAT THE MEASUREMENT DID NOT MATCH AND CHECKED THE PACKAGING. THERE THEY NOTICED THAT THE ENVELOPE THAT CAME INSIDE THE BOX WAS A DIFFERENT SIZE (5.8FR) AND DID NOT MATCH WHAT THE BOX INDICATED. SINCE THE DEVICE WAS ALREADY INSTALLED IN THE PATIENT, THEY LEFT IT. ACCORDING TO THE FORM, THE PRODUCT WAS USED ONLY ONCE. ONE PICTURE WAS PROVIDED BY THE CUSTOMER SHOWING A BOX WITH THE LABEL OF THE PRODUCT. THE EVENT WAS CLASSIFIED AS AN ADVERSE EVENT, AN INCORRECT MEASURING DEVICE WAS INSTALLED ON THE PATIENT.. THIS EVENT HAPPENED IN TWO SURGERIES WITH THE SAME DOCTOR AND ONE PATIENT INVOLVED IN THIS EVENT. INFORMING THAT THERE WAS NO DAMAGE TO THE PATIENT, BUT A MEASURE THAT WAS NOT WHAT THE DOCTOR WANTED WAS INSTALLED. THE PRODUCT IS CURRENTLY INSTALLED IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20296544 ↗
• InjuryAug 24, 2023Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT A PATIENT WAS SENT TO HAVE THE DEVICE REMOVED DUE TO IT BREAKING. THE DEVICE WAS IMPLANTED (B)(6) 2023 AND RECENTLY DEVELOPED AN "ISSUE". ADVERSE PATIENT EFFECTS ARE UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 17616190 ↗
• InjuryMay 12, 2023Fracture; Material Separation; Fracture; Material Separation

  IT WAS REPORTED THAT A PORT-A-CATH DEVICE WAS IN USE FOR ONE YEAR WHEN IT SEPARATED FROM OR BROKEN APART FROM THE PORT AND BECAME FREE FLOATING INSIDE PATIENT. DEVICE WAS SURGICALLY REMOVED. NO ADVERSE EFFECTS REPORTED.

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 16919162 ↗
• InjuryMay 9, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PORT-A-CATH THAT WAS IN USE FOR TWO YEARS WAS FOUND SEPARATED FROM OR BROKEN APART FROM THE PORT INSIDE THE PATIENT. AN X-RAY WAS TAKEN TO SEE THE PRODUCT "FREE FLOATING" IN THE BODY. DEVICE WAS SURGICALLY REMOVED. NO ADVERSE EFFECTS REPORTED.

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 16899383 ↗
• InjuryJan 12, 2023Fracture; Fracture

  THE PATIENT REPORTED PAIN AT THE SITE AFTER UNDERGOING CHEMOTHERAPY. A PAC STUDY WAS DONE WHICH IDENTIFIED A FRACTURE IN THE DEVICE BELOW THE CLAVICLE. DURING THE DEVICE REMOVAL, THE PAC RESERVOIR WAS REMOVED AND PRESERVED FOR RETURN TO THE MANUFACTURER. A FRACTURE WAS NOTED AT THE HUB OF THE RESERVOIR WHERE THE CATHETER WAS ANCHORED TO THE DEVICE. THE REMAINING CATHETER HAD RETRACTED INTO THE VEIN, INFERIOR TO THE CLAVICLE AND THE SURGEON WAS NOT ABLE TO RETRIEVE THE CATHETER. THE PATIENT WAS REFERRED TO INTERVENTIONAL RADIOLOGY FOR REMOVAL. ADDITIONAL INFORMATION RECEIVED BY SMITHS MEDICAL/ICU ON 04-JAN-2022 VIA EMAIL: PATIENT UNDERWENT CATHETER RETRIEVAL AND PORT REPLACEMENT (TODAY) (B)(6) 2022 AT A TERTIARY CARE CENTER. PATIENT HAD A CHEST X-RAY DONE AND FLUOROSCOPY FOR THE CATHETER RETRIEVAL AND PORT INSERTION AND HAD TO GO TO A TERTIARY CARE CENTER FOR CATHETER REMOVAL IN INTERVENTIONAL RADIOLOGY AND TO HAVE A SECOND PORT PLACED.

  Patient problems: Device Embedded In Tissue or Plaque; Failure of Implant; Implant Pain; Pain

  MAUDE report 16152042 ↗
• MalfunctionSep 30, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THERE WAS DEVICE LEAKAGE. THERE HAS BEEN NO REPORT OF PATIENT INVOLVEMENT OR NO OBSERVABLE CLINICAL SYMPTOMS OR A CHANGE IN SYMPTOMS IDENTIFIED IN THE PATIENT.

  Patient problems: Discomfort; Distress; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15521066 ↗
• InjurySep 2, 2022Difficult to Flush; Fracture; Obstruction of Flow; Difficult to Flush; Fracture; Obstruction of Flow

  IT WAS REPORTED THAT A PATIENT WAS TAKEN TO THE OPERATING ROOM FOR REPLACEMENT OF THE DEVICE, SECONDARY TO THE DEVICE CLOTTING OFF, WOULD NOT FLUSH WITH EXTRAVASATION OF FLUID AROUND THE RESERVOIR. THE PATIENT HAD RECEIVED NEOADJUVANT THERAPY SINCE PLACEMENT OF THE CATHETER. UPON REMOVAL OF THE CATHETER, IT WAS NOTICED TO HAVE A FRACTURE IN THE MIDPORTION OF THE CATHETER WHICH WOULD HAVE BEEN PRESENT FROM MANUFACTURE DATE. SERIOUS INJURY DUE TO FAILURE OF IMPLANT WAS REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 15352663 ↗
• MalfunctionAug 31, 2022Leak/Splash; Material Puncture/Hole; Leak/Splash; Material Puncture/Hole

  IT WAS REPORTED THAT LEAKAGE WAS DETECTED BETWEEN MARKINGS 55 AND 60 CM OF THE CATHETER AND A JOINT WAS NOTED TO HAVE SEVERAL HOLES. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15326752 ↗
• InjuryAug 18, 2022Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

  IT WAS REPORTED THAT THE DEVICE WAS EXPLANTED ON (B)(6) 2022 AND WAS NOTED TO HAVE A FRACTURE IN THE BODY OF THE DEVICE, ALLOWING EXTRAVASATION OF INFUSED FLUIDS. UNKNOWN IF THERE WAS PATIENT INJURY. THE PATIENT RECEIVED CHEMOTHERAPY THROUGH PORT PRIOR TO AWARENESS THAT THERE WAS A DEFECT. THE DEVICE WAS REMOVED AND REPLACED. ADDITIONAL INFORMATION WAS REQUESTED; HOWEVER, NO FURTHER INFORMATION WAS RECEIVED.

  Patient problems: Extravasation

  MAUDE report 15249680 ↗
• MalfunctionApr 22, 2022Device Damaged Prior to Use; Device Damaged Prior to Use

  IT WAS REPORTED THAT THE CATHETER SCUFFED AT TIP AND NOT CONICALLY SHAPED AS USUAL. NORMALLY, THE END TO BE IMPLANTED IS CONICALLY GROUND/SHAPED. THE CATHETER WAS NOT IMPLANTED AND A NEW PORT FROM A DIFFERENT LOT WAS APPLIED. NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14186760 ↗
• InjuryDec 29, 2021Crack; Crack

  IT WAS REPORTED THAT A PORT WAS INSERTED TO A PATIENT ON (B)(6) 2018. PATIENT EXPERIENCED PAIN AT INSERTION SITE FOR FEW WEEKS. SUBSEQUENT FLUOROSCOPY EXAMINATION (ON (B)(6) 2019) REVEALED THE NEED FOR REMOVAL DUE TO DYSFUNCTION-LEAKING INTO POCKET AND ALONG THE COURSE OF THE PORT WAS NOTED ON IMAGING AND DEVICE REMOVED (B)(6) 2019. PATIENT HAD TO UNDERGO FLUOROSCOPY IMAGING AND EXTRA SURGERY FOR REMOVAL AND INSERTION OF NEW PORT A CATH. UPON REMOVAL ON THE MAYO STAND THE RESERVOIR WAS INJECTED WITH SALINE AND IT WAS SHOWN THAT THERE WAS A TEAR IN THE CATHETER ITSELF, BOUT 5 CM FROM THE HUB. NO PATIENT INJURY WAS REPORTED.

  Patient problems: Implant Pain

  MAUDE report 13114716 ↗
• InjurySep 18, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL PORT-A-CATH TRAY WAS RUBBING WHERE THE CLAVICLE IS LOCATED ON THE PATIENT. AN X-RAY WAS DONE TO REVEAL A TEN CM PIECE HAD REMAINED IN THE PATIENT UPON REMOVAL OF THE DEVICE. THE PATIENT THEN HAD THE CATHETER STUMP REMOVED FROM THE HEART VIA THE GROIN IN THE OPERATION ROOM. NO FURTHER ADVERSE EFFECTS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9084021 ↗
• InjurySep 6, 2018Crack; Crack

  INFORMATION WAS RECEIVED INDICATING THAT A PATIENT WITH A SMITHS MEDICAL DELTEC® PORT-A-CATH®II WAS FOUND TO HAVE PAIN UPON FLUSHING SIX MONTHS FOLLOWING IMPLANT. A VENOGRAM WAS ORDERED AND PERFORMED THAT DAY NOTING CRACKED TUBING. SUBSEQUENTLY, THE PORT WAS REQUIRED TO BE EXPLANTED AND REPLACED. NO FURTHER ADVERSE EFFECTS WERE REPORTED.

  Patient problems: Pain

  MAUDE report 7851760 ↗
• InjuryFeb 16, 2018Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE EXPLANTING DOCTOR NOTICED HOLES IN THE CATHETER OF A DELTEC® PORT-A-CATH®II POWER P.A.C. IMPLANTABLE ACCESS SYSTEM. ISSUES WITH THE CATHETER HAD TO BE EXPLANTED WHEN ONE PATIENT COMPLAINED OF PAIN. THERE WAS NO PATIENT INJURY ASSOCIATED WITH THIS OCCURRENCE.

  Patient problems: Pain

  MAUDE report 7278788 ↗
• InjuryDec 12, 2017Hole In Material; Hole In Material

  INFORMATION WAS RECEIVED INDICATING THAT AT THE END OF THERAPY THE EXPLANTING DOCTOR NOTICED HOLES IN THE CATHETER OF THIS PORT. THE PORT HAD TO BE EXPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7110043 ↗

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.