Deltec 21-4475-24Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 10610586039973), received between Nov 9, 2017 and Feb 16, 2026 — classified as 4 injuries, 23 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (5 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 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 16, 2026Peeled/Delaminated

  IT WAS REPORTED THAT THE PEEL-AWAY SHEATH DEFECT (THE VALVE DOES NOT PEEL OFF PROPERLY OR PEELS OFF UNEVENLY TO ONE SIDE). EIGHT (8) PHYSICAL SAMPLES WERE RETRIEVED, AND (B)(4) UNITS WERE DISCARDED. THERE WAS PATIENT INVOLVEMENT AND THERE WAS NO PATIENT HARM. EVENT OCCURRED AT THE HOSPITAL, AND THE OPERATOR OF THE DEVICE WAS A HEALTH PROFESSIONAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24349380 ↗
• MalfunctionFeb 16, 2026Peeled/Delaminated

  IT WAS REPORTED THAT THE PEEL-AWAY SHEATH DEFECT (THE VALVE DOES NOT PEEL OFF PROPERLY OR PEELS OFF UNEVENLY TO ONE SIDE). EIGHT (8) PHYSICAL SAMPLES WERE RETRIEVED, AND TWO (2) UNITS WERE DISCARDED. THERE WAS PATIENT INVOLVEMENT AND THERE WAS NO PATIENT HARM. EVENT OCCURRED AT THE HOSPITAL, AND THE OPERATOR OF THE DEVICE WAS A HEALTH PROFESSIONAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24349379 ↗
• MalfunctionFeb 16, 2026Peeled/Delaminated

  IT WAS REPORTED THAT THE PEEL-AWAY SHEATH DEFECT (THE VALVE DOES NOT PEEL OFF PROPERLY OR PEELS OFF UNEVENLY TO ONE SIDE). EIGHT (8) PHYSICAL SAMPLES WERE RETRIEVED, AND TWO (2) UNITS WERE DISCARDED. THERE WAS PATIENT INVOLVEMENT AND THERE WAS NO PATIENT HARM. EVENT OCCURRED AT THE HOSPITAL, AND THE OPERATOR OF THE DEVICE WAS A HEALTH PROFESSIONAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24349378 ↗
• MalfunctionDec 31, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT THE PORT-A-CATH WAS NOTED TO BE SEPARATED DURING REMOVAL, WITH PART OF THE DEVICE NOT RECOVERED AT TIME OF REMOVAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23933411 ↗
• MalfunctionSep 8, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT THE PORT AND CATHETER DISCONNECTED WHILE IN USE WITH PATIENT AT THE HOSPITAL. NO PATIENT HARM/ADVERSE EVENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22998862 ↗
• MalfunctionJul 9, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE SHEATH'S OUTER SURFACE (THE SKY-BLUE PART) WAS SPLIT IN HALF NORMALLY, THE ¿SILICON VALVE¿ (TRANSPARENT ROUND VALVE) WAS LEFT ALONE, NOT SPLIT IN HALF. THE EVENT OCCURRED WHILE IN USE WITH A PATIENT, AND THERE WAS NO PATIENT INJURY, AND NO MEDICAL INTERVENTION REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22463159 ↗
• MalfunctionNov 18, 2024Fracture; Fracture

  IT WAS REPORTED THAT THE TUBING WAS BROKEN, AND THE MEDICATION WAS NOT WORKING WELL. THE EVENT OCCURRED DURING WHILE IN USE WITH A PATIENT. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20712637 ↗
• MalfunctionAug 23, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE SHEATH'S OUTER SURFACE (THE SKY-BLUE PART) WAS SPLIT IN HALF; NORMALLY, THE SILICON VALVE (TRANSPARENT ROUND VALVE) WAS LEFT ALONE, NOT SPLIT IN HALF. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20048838 ↗
• MalfunctionAug 22, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE SHEATH'S OUTER SURFACE (THE SKY-BLUE PART) WAS SPLIT IN HALF, NORMALLY, THE SILICON VALVE (TRANSPARENT ROUND VALVE) WAS LEFT ALONE, NOT SPLIT IN HALF. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20044195 ↗
• MalfunctionAug 22, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE SHEATH'S OUTER SURFACE (THE SKY-BLUE PART) WAS SPLIT IN HALF, NORMALLY, THE SILICON VALVE (TRANSPARENT ROUND VALVE) WAS LEFT ALONE, NOT SPLIT IN HALF. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20034806 ↗
• MalfunctionAug 22, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE SHEATH'S OUTER SURFACE (THE SKY-BLUE PART) WAS SPLIT IN HALF, NORMALLY, THE SILICON VALVE (TRANSPARENT ROUND VALVE) WAS LEFT ALONE, NOT SPLIT IN HALF. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20032430 ↗
• MalfunctionOct 12, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT THE CATHETER WAS CUT OFF AND THE PROCEDURE COULD NOT PROCEED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15591842 ↗
• MalfunctionOct 12, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT THE CATHETER WAS CUT OFF AND THE PROCEDURE COULD NOT PROCEED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15591821 ↗
• MalfunctionOct 12, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT THE CATHETER WAS CUT OFF AND THE PROCEDURE COULD NOT PROCEED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15591816 ↗
• MalfunctionOct 5, 2022Infusion or Flow Problem; No Flow; Infusion or Flow Problem; No Flow

  IT WAS REPORTED THAT UPON OPENING THE PORT, IT WAS DETERMINED IT HAD NO FLOW. THERE HAS BEEN NO REPORT OF PATIENT INVOLVEMENT OR NO OBSERVABLE CLINICAL SYMPTOMS OR A CHANGE IN SYMPTOMS IDENTIFIED IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15543544 ↗
• MalfunctionSep 1, 2022Device Slipped; Device Slipped

  IT WAS REPORTED THAT WHEN THE USER PULLED THE CATHETER TO COMBINE IT INTO THE CONNECTOR, THE CATHETER SLID OUT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15337065 ↗
• MalfunctionSep 1, 2022Device Slipped; Device Slipped

  IT WAS REPORTED THAT WHEN THE USER PULLED THE CATHETER TO COMBINE IT INTO THE CONNECTOR, THE CATHETER SLID OUT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15336185 ↗
• MalfunctionSep 1, 2022Device Slipped; Device Slipped

  IT WAS REPORTED THAT WHEN THE USER PULLED THE CATHETER TO COMBINE IT INTO THE CONNECTOR, THE CATHETER SLID OUT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15336128 ↗
• MalfunctionSep 1, 2022Separation Problem; Separation Problem

  IT WAS REPORTED THAT THE PROFESSOR COMBINED THE CATHETER TO THE CONNECTOR BUT WHEN HE TRIED TO PULL THE CATHETER, THE CATHETER SLID OUT OF THE CONNECTOR. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15335820 ↗
• MalfunctionFeb 4, 2022Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE DEVICE FAILED TO INSERT DUE TO HIGH PORT PROFILE DURING THE L PORT INSERTION PROCESS. NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13453464 ↗
• MalfunctionFeb 4, 2022Connection Problem; Connection Problem

  IT WAS REPORTED THAT THE PORT CONNECTOR IS DEFECTIVE. NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13453394 ↗
• MalfunctionFeb 4, 2022Connection Problem; Connection Problem

  IT WAS REPORTED THAT THE PORT CONNECTOR IS DEFECTIVE. NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13453297 ↗
• MalfunctionFeb 1, 2022Break; Break

  IT WAS REPORTED THAT THE CONNECTOR IS SMALL AND THE CATHETER CAN NOT ENTER.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 13417768 ↗
• InjuryDec 29, 2021Device Damaged Prior to Use; Device Damaged Prior to Use

  IT WAS REPORTED THE GUIDEWIRE WAS FRAYED AND BROKE DURING AN ATTEMPTED PORT PLACEMENT AT THE SUBCLAVIAN VEIN PORT, LEAVING A PIECE OF THE BROKEN WIRE IN THE PATIENT, CAUSING SURGEON'S CONCERN REGARDING REMOVAL OF THE GUIDEWIRE AND THE PATIENT'S SAFETY. A DECISION WAS MADE TO TRANSFER THE PATIENT TO THE MAIN HOSPITAL (EMS) WHERE DIAGNOSTIC IMAGING WAS AVAILABLE (CT) AND THE WIRE WAS SAFELY REMOVED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13115025 ↗
• InjurySep 6, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED INDICATING THAT A PATIENT WITH A SMITHS MEDICAL DELTEC® PORT-A-CATH®II WAS FOUND TO HAVE AN INFECTION AT THE PORT SITE. SUBSEQUENTLY, IT WAS REQUIRED TO EXPLANT THE PORT AND REPLACE IT WITH A NEW ONE. NO FURTHER ADVERSE EFFECTS WERE REPORTED.

  Patient problems: Unspecified Infection

  MAUDE report 7851679 ↗

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.