Deltec 21-4591-24Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10610586021565), received between Sep 28, 2017 and Apr 6, 2026 — classified as 4 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (2 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 6, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THE TUBE EXHIBITED A LEAKAGE DURING USE. THERE WAS PATIENT INVOLVEMENT, NO INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24791049 ↗
• MalfunctionJan 23, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT DURING USE OF AN IMPLANTED VASCULAR ACCESS DEVICE, A MALFUNCTION OCCURRED AT THE CONNECTION BETWEEN THE CATHETER AND THE PORT, RESULTING IN LEAKAGE OF INFUSED FLUID INTO SURROUNDING TISSUE. THIS EVENT WAS REPORTED AS AN ADVERSE EVENT AND INVOLVED A PATIENT. THE PATIENT EXPERIENCED PAIN AND SWELLING, AND A SECOND PROCEDURE WAS REQUIRED TO REMOVE AND REPLACE THE DEVICE. DURING THE AFFECTED SESSION, ONLY SALINE WAS BEING ADMINISTERED, AND NO CHEMOTHERAPY DRUGS WERE INFUSED. THE PATIENT REMAINED STABLE, AND NO PERMANENT INJURY OR PATIENT HARM WAS REPORTED. A NEW DEVICE WAS IMPLANTED WITHOUT DIFFICULTY, AND THE PATIENT IS CURRENTLY IN GOOD CONDITION.

  Patient problems: Extravasation; Pain; Swelling/ Edema

  MAUDE report 24169056 ↗
• MalfunctionJan 10, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE PLACEMENT OF THE IMPLANTABLE DRUG DELIVERY DEVICE, THE METAL STEM AND CATHETER OF THE CONNECTION PART OF THE PORT SEAT WERE FOUND TO BE DETACHED WHEN THE CATHETER WAS CONNECTED TO THE PORT SEAT AFTER THE CATHETER WAS INSERTED, SO THE PRODUCT WAS REPLACED. THERE WAS PATIENT INVOLVEMENT REPORTED AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21129561 ↗
• InjuryMay 30, 2023Break; Crack; Break; Crack

  IT WAS REPORTED THAT A PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO FOURTH-DEGREE BONE MARROW SUPPRESSION. DURING THE INFUSION OF NUTRIENT SOLUTION, IT SUDDENLY STOPPED DRIPPING. DURING THE PROCESS OF RECONFIRMING WHETHER THE CATHETER WAS UNOBSTRUCTED, THE PATIENT'S NECK WAS FOUND TO BE SWOLLEN, AND THE CATHETER WAS INTERRUPTED. THE SWELLING WAS CONFIRMED BY DIGITAL SUBTRACTION ANGIOGRAPHY (DSA) IN THE INTERVENTIONAL DEPARTMENT AND THERE WAS A CRACK IN THE CATHETER AND THE CATHETER CONTRAST AGENT LEAKED OUT.

  Patient problems: Swelling/ Edema

  MAUDE report 17019014 ↗
• InjuryAug 16, 2021Disconnection; Disconnection

  INFORMATION RECEIVED A SMITHS MEDICAL IMPLANTABLE PORTS/DELTEC P.A.S.PORT PORTS CAUSED AND ADVERSE EVENT. REPORTED THE PATIENT WAS NORMAL UNTIL ONE MONTH OF IMPLANTATION, THE BLOOD COULD NOT BE DRAWN OUT WHEN MEDICINE WAS INJECTED AT THE HOSPITAL. FILM WAS TAKEN, AND IT WAS FOUND THAT THE CATHETER FELL INTO THE HEART. EMERGENCY REMOVAL WAS REQUIRED. PHOTOS OF PRODUCT AND XRAYS ATTACHED. THIS REQUIRED EMERGENT SURGICAL INTERVENTION TO REMOVE THE DISCONNECT PART THAT FELL IN TO THE HEART.

  Patient problems: Foreign Body In Patient

  MAUDE report 12325486 ↗
• InjuryAug 9, 2019Material Fragmentation; Material Separation; Detachment of Device or Device Component; Material Fragmentation; Material Separation; Detachment of Device or Device Component

  INFORMATION WAS RECEIVED THAT A 10 CM PORTION OF A SMITHS MEDICAL PORT TUBE WAS PULLED OUT UPON REMOVAL OF THE SYSTEM. THE POINT OF RUPTURE WAS REPORTED TO BE YELLOWISH, BOTH ENDS OF THE DEVICE ARE FEATHERED AND TORN. ADDITIONALLY, THE MATERIAL HAS BEEN REPORTED TO BE POROUS. THE REMAINING 10 CM LONG PART WAS RECOVERED ANGIOGRAPHICALLY. NO FURTHER ADVERSE EFFECTS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8879167 ↗
• InjurySep 28, 2017Break; Break

  IT WAS REPORTED THAT SEVEN DAYS AFTER PLACEMENT, A DELTEC® P.A.S. PORT® POWER P.A.C. IMPLANTABLE ACCESS SYSTEM WAS UNABLE TO HAVE BLOOD DRAWN FROM IT, AND WHEN THE NURSE FLUSHED THE PORT, EXTRAVASATION WAS OBSERVED. AN X-RAY WAS PERFORMED AND SHOWED THE PORT CONNECTOR WAS BROKEN. THE PORT WAS SURGICALLY REMOVED. THE EVENT WAS RESOLVED AFTER IMPLANTING A NEW PORT. NO PERMANENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6900120 ↗