Deltec 21-4485-24Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10610586032790), received between Apr 8, 2020 and Apr 4, 2023 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Fluid/Blood Leak” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryApr 4, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE CATHETER ATTACHED TO PORT CHAMBER LEAKED. THE LEAK WAS DISCOVERED DURING EVALUATION OF IMPLANTED DEVICE IN-SITU VIA CONTRAST INJECTION. SEDATION WAS PROVIDED, THE DEFECTIVE ASSEMBLY WAS REMOVED AND A NEW DEVICE WAS INSTALLED. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16672738 ↗
• InjurySep 13, 2021Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THE DEVICE WAS IN PATIENT USE. THE DEVICE WAS REMOVED DUE TO A HOLE FOUND IN CATHETER THAT WAS IDENTIFIED UPON FLUOROSCOPY. THE SURGICAL REMOVAL OCCURRED WITH NO FURTHER ADVERSE EFFECTS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12460846 ↗
• InjuryJan 21, 2021Contamination; Contamination

  INFORMATION FROM (B)(6) ON A DELTEC PORT A CATH. PATIENT HAD A DELTEC PORT-A-CATH POWER PAC INSERTED FOR ANTINEOPLASTIC THERAPY ADMINISTRATION BY A INTERVENTIONAL RADIOLOGY (B)(6) 2019. PORT USED FOR TREATMENT UNTIL (B)(6) 2019. ON (B)(6) 2020 PATIENT PRESENTED WITH LOCALIZED INFECTION OF PORT SITE, WITH NIL PRECEDING TRAUMA. PORT HAD NOT BEEN ACCESSED FOR 12 MONTHS PRIOR TO SPONTANEOUS DEVELOPMENT OF INFECTION. PORT-A-CATH SURGICALLY REMOVED DUE TO LOCALIZED INFECTION ON (B)(6) 2020.

  Patient problems: Infection, Direct

  MAUDE report 11211129 ↗
• InjuryApr 18, 2020Break; Fracture; Material Integrity Problem; Break; Fracture; Material Integrity Problem

  INFORMATION WAS RECEIVED THAT A PATIENT HAD A SMITHS MEDICAL DELTEC POWER PORT-A-CATH II PORT INSERTED (B)(6) 2018. ON (B)(6) 2019, INFUSAPORT COULD NOT BE ASPIRATED OR FLUSHED CT SHOWED WAS IN CORRECT POSITION BUT HAD A CATHETER FRACTURE 4CM FROM THE DISTAL APEX.. IT WAS REQUIRED TO REMOVE THE PORT AND PLACE A PICC LINE. NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9975725 ↗
• MalfunctionApr 8, 2020Fluid/Blood Leak; Defective Component; Connection Problem; Fluid/Blood Leak; Defective Component; Connection Problem

  INFORMATION RECEIVED A SMITHS MEDICAL IMPLANTABLE PORTS/DELTEC POWER PORT-A-CATH II PORTS WAS OBSERVED LEAKING AROUND DISTAL CONNECTION TO PORT. A NEW DEVICE WAS INSERTED ON PATIENT . NO PATIENT ADVERSE EVENTS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9941141 ↗

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.