Deltec 21-4590-24Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10610586021541), received between Feb 23, 2021 and Jun 19, 2023 — classified as 6 injuries.

The most frequently reported specific device problem is “Fluid/Blood Leak” (5 reports).

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJun 19, 2023Fluid/Blood Leak; Radiation Leak; Fluid/Blood Leak; Radiation Leak

  IT WAS REPORTED THAT THE 8TH NEOADJUVANT CHEMOTHERAPY FOR RIGHT BREAST CANCER WAS COMPLETED. DURING THE REMOVAL OF THE BUTTERFLY WING NEEDLE BY HEPARIN SALINE SEAL, THE BOLUS INJECTION WAS NOT SMOOTH, AND THE PATIENT FELT TINGLING PAIN AND DISCOMFORT IN THE NECK, AND THE BOLUS INJECTION WAS SUSPENDED. CONTACTED THE INTERVENTIONAL DEPARTMENT TO PERFORM A DIGITAL SUBTRACTION ANGIOGRAPH (DSA) TO FIND LEAKAGE NEAR THE NECK. REPORTED TO THE DOCTOR IN CHARGE AND REMOVED THE CATHETER.

  Patient problems: Implant Pain; Neuropathy; Pain; Unintended Radiation Exposure

  MAUDE report 17157806 ↗
• InjuryMay 8, 2023Fluid/Blood Leak; Radiation Leak; Infusion or Flow Problem; Fluid/Blood Leak; Radiation Leak; Infusion or Flow Problem

  IT WAS REPORTED THAT A PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO FOURTH-DEGREE MYELOSUPPRESSION. DURING THE INFUSION OF NUTRIENT SOLUTION, THE INFUSION "SUDDENLY STOPPED", AND THE PATIENT'S NECK WAS FOUND TO BE SWOLLEN DURING THE PROCESS. THE CATHETER WAS CONFIRMED TO BE BROKEN AND CRACKED VIA DIGITAL SUBTRACTION ANGIOGRAPHY (DSA) AT THE RADIOLOGY DEPARTMENT. LEAKAGE OF CONTRAST MEDIUM FROM THE CATHETER. NO ADVERSE EFFECTS REPORTED.

  Patient problems: Swelling/ Edema

  MAUDE report 16889541 ↗
• InjuryApr 21, 2023Fluid/Blood Leak; Radiation Leak; Infusion or Flow Problem; Fluid/Blood Leak; Radiation Leak; Infusion or Flow Problem

  IT WAS REPORTED THAT THE NURSE FOUND THAT THE PATIENT'S NECK WAS SIGNIFICANTLY SWOLLEN DURING THE INFUSION OF CHEMOTHERAPY DRUGS, AND THE CHEMOTHERAPY DRUGS LEAKED OUT. THE CONNECTION OF THE PORT CATHETER WAS RUPTURED WHICH SHOWN BY CONTRAST AGENT DURING THE DIGITAL SUBTRACTION ANGIOGRAPHY (DSA) AT THE RADIOLOGY DEPARTMENT. THE DEVICE WAS THEN IMMEDIATELY REMOVED.

  Patient problems: Swelling/ Edema

  MAUDE report 16791926 ↗
• InjuryApr 21, 2023Fluid/Blood Leak; Radiation Leak; Infusion or Flow Problem; Fluid/Blood Leak; Radiation Leak; Infusion or Flow Problem

  IT WAS REPORTED THAT THE NURSE FOUND THAT THE PATIENT'S NECK WAS SIGNIFICANTLY SWOLLEN DURING THE INFUSION OF CHEMOTHERAPY DRUGS, AND THE CHEMOTHERAPY DRUGS LEAKED OUT. THE CONNECTION OF THE PORT CATHETER WAS RUPTURED WHICH SHOWN BY CONTRAST AGENT DURING THE DIGITAL SUBTRACTION ANGIOGRAPHY (DSA) AT THE RADIOLOGY DEPARTMENT. THE DEVICE WAS THEN IMMEDIATELY REMOVED.

  Patient problems: Swelling/ Edema

  MAUDE report 16791917 ↗
• InjuryApr 21, 2023Fluid/Blood Leak; Radiation Leak; Infusion or Flow Problem; Fluid/Blood Leak; Radiation Leak; Infusion or Flow Problem

  IT WAS REPORTED THAT THE NURSE FOUND THAT THE PATIENT'S NECK WAS SIGNIFICANTLY SWOLLEN DURING THE INFUSION OF CHEMOTHERAPY DRUGS, AND THE CHEMOTHERAPY DRUGS HAD LEAKED OUT. THE CONNECTION OF THE PORT CATHETER WAS RUPTURED WHICH WAS SHOWN BY CONTRAST AGENT DURING THE DIGITAL SUBTRACTION ANGIOGRAPHY (DSA) AT THE RADIOLOGY DEPARTMENT. THE DEVICE WAS THEN IMMEDIATELY REMOVED.

  Patient problems: Swelling/ Edema

  MAUDE report 16791914 ↗
• InjuryFeb 23, 2021Break; Material Fragmentation; Break; Material Fragmentation

  IT WAS REPORTED THAT THE PORT WAS IMPLANTED IN 2016, AND AFTER 5 YEARS THE CATHETER TEAR OFF. URGENT CATH LAB OPERATION REQUIRED. ACCESS POINT RIGHT SUBCLAVIAN VEIN, UNDER ULTRASOUND, DISTAL TO CLAVICLE. PATIENT FELT PAIN AT PORT WHEN FLUSHING - NO REFLUX. REMOVED UNDER LOCAL ANESTHESIA. CUT OVER PREVIOUS CUT, PORT REMOVED. PRELIMINARY RTG PC DONE AND OBSERVED CATHETER IN THE HEART. APPLICABLE ATTRIBUTES UPDATED. PATIENT INFORMATION UPDATED. CATHETER ALSO ALREADY REMOVED BY INTERVENTIONAL RADIOLOGIST.

  Patient problems: No Consequences Or Impact To Patient; Pain

  MAUDE report 11364585 ↗