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LOCKING TITANIUM ADAPTER FOR PERITONEAL DIALYSIS CATHETER 5C4129 (UDI 07332414207946)Recalls & reported problems

Vantive US Healthcare LLC · This adapter is a double sealing female Luer lock adapter with a 2-piece, combination compression fit/barbed catheter connector. The adapter is used to connect the PD catheter to a solution transfer set with locking connector. · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
5
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07332414207946), received between Feb 12, 2026 and May 19, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Disconnection” (2 reports).

13 other recalls cover devices cleared under the same FDA submission (K152675); 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 18, 2026.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 2 reportsMar 2026: 0 reportsApr 2026: 2 reportsMay 2026: 1 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520262
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Disconnection2
  • Fluid/Blood Leak2
  • Packaging Problem1
  • Unsealed Device Packaging1

Patient problems

  • No Clinical Signs, Symptoms or Conditions5

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMay 19, 2026Unsealed Device Packaging

    IT WAS REPORTED THAT THE OUTER PACKAGING OF A LOCKING TITANIUM ADAPTER FOR PERITONEAL DIALYSIS CATHETER WAS NOT SEALED. THIS WAS IDENTIFIED IN THE HOSPITAL OPERATING ROOM PRIOR TO USE ON A PATIENT. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25219401 ↗
  • MalfunctionApr 21, 2026Fluid/Blood Leak

    IT WAS REPORTED THAT THERE WAS A LEAK BETWEEN THE TITANIUM ADAPTER AND MINICAP TRANSFER SET. THIS OCCURRED DURING USE OF THE DEVICES FOR PERITONEAL DIALYSIS THERAPY. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24941342 ↗
  • MalfunctionApr 16, 2026Disconnection

    IT WAS REPORTED THAT THERE WAS A DISCONNECTION BETWEEN THE TITANIUM ADAPTER AND NON-VANTIVE CATHETER. THIS OCCURRED DURING USE OF THE DEVICE FOR PERITONEAL DIALYSIS THERAPY. THE TITANIUM ADAPTER WAS REPLACED BECAUSE OF THE ISSUE. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT; HOWEVER, THE PATIENT WAS TREATED WITH PROPHYLACTIC ANTIBIOTICS. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24896721 ↗
  • MalfunctionFeb 27, 2026Disconnection; Fluid/Blood Leak

    IT WAS REPORTED THAT THE TITANIUM ADAPTER DISCONNECTED FROM AN UNSPECIFIED TUBE WHICH RESULTED IN A LEAK. THIS OCCURRED DURING USE OF THE DEVICE FOR PERITONEAL DIALYSIS THERAPY. THE TITANIUM ADAPTER WAS REPLACED. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT; HOWEVER, THE PATIENT WAS TREATED WITH ANCEF 1.5G. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24471573 ↗
  • MalfunctionFeb 12, 2026Packaging Problem

    IT WAS REPORTED THAT THE PACKAGING OF THE TITANIUM ADAPTER WAS DAMAGED. THIS WAS IDENTIFIED BEFORE USE OF THE DEVICE FOR PERITONEAL DIALYSIS THERAPY. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24326656 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K152675. One submission often covers many models, so check the product and lot details in each record.

  • Z-0559-2025 · Oct 23, 2024 · Open, Classified
    Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482; use in Peritoneal Dialysis
  • Z-0373-2025 · Oct 21, 2024 · Open, Classified
    Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482; use in Peritoneal Dialysis
  • Z-0572-2022 · Jan 7, 2022 · Open, Classified
    Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Short, 5C4483
  • Z-0577-2022 · Jan 7, 2022 · Open, Classified
    Baxter MiniCap Extended Life PD Transfer Set Twist Clamp - Extra Short, REF R5C4483
  • Z-0579-2022 · Jan 7, 2022 · Open, Classified
    Baxter CAPD System Transfer Set (CAPD MiniCap Transfer Set II (24cm)), Code No. T5C4482
  • Z-0580-2022 · Jan 7, 2022 · Open, Classified
    Baxter CAPD System Transfer Set (CAPD MiniCap Transfer Set II (34cm)), Code No. T5C4484
  • Z-0576-2022 · Jan 7, 2022 · Open, Classified
    Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, REF R5C4482E
  • Z-0578-2022 · Jan 7, 2022 · Open, Classified
    Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Long, REF R5C4484
  • Z-0571-2022 · Jan 7, 2022 · Open, Classified
    Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, 5C4482
  • Z-0570-2022 · Jan 7, 2022 · Open, Classified
    Baxter MiniCap Extended Life PD Transfer Set (Easy-Lock), 5C4449
  • Z-0573-2022 · Jan 7, 2022 · Open, Classified
    Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, 5C4482EJ
  • Z-0574-2022 · Jan 7, 2022 · Open, Classified
    Baxter Equipo de transferencia para DP MiniCap de vida util prolongada con pinza de torsion, 5C4482S
  • Z-0575-2022 · Jan 7, 2022 · Open, Classified
    Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, REF R5C4482

Other SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE devices

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Sources and updates

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