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
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, ClassifiedBaxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482; use in Peritoneal Dialysis
- Z-0373-2025 · Oct 21, 2024 · Open, ClassifiedBaxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482; use in Peritoneal Dialysis
- Z-0572-2022 · Jan 7, 2022 · Open, ClassifiedBaxter MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Short, 5C4483
- Z-0577-2022 · Jan 7, 2022 · Open, ClassifiedBaxter MiniCap Extended Life PD Transfer Set Twist Clamp - Extra Short, REF R5C4483
- Z-0579-2022 · Jan 7, 2022 · Open, ClassifiedBaxter CAPD System Transfer Set (CAPD MiniCap Transfer Set II (24cm)), Code No. T5C4482
- Z-0580-2022 · Jan 7, 2022 · Open, ClassifiedBaxter CAPD System Transfer Set (CAPD MiniCap Transfer Set II (34cm)), Code No. T5C4484
- Z-0576-2022 · Jan 7, 2022 · Open, ClassifiedBaxter MiniCap Extended Life PD Transfer Set with Twist Clamp, REF R5C4482E
- Z-0578-2022 · Jan 7, 2022 · Open, ClassifiedBaxter MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Long, REF R5C4484
- Z-0571-2022 · Jan 7, 2022 · Open, ClassifiedBaxter MiniCap Extended Life PD Transfer Set with Twist Clamp, 5C4482
- Z-0570-2022 · Jan 7, 2022 · Open, ClassifiedBaxter MiniCap Extended Life PD Transfer Set (Easy-Lock), 5C4449
- Z-0573-2022 · Jan 7, 2022 · Open, ClassifiedBaxter MiniCap Extended Life PD Transfer Set with Twist Clamp, 5C4482EJ
- Z-0574-2022 · Jan 7, 2022 · Open, ClassifiedBaxter Equipo de transferencia para DP MiniCap de vida util prolongada con pinza de torsion, 5C4482S
- Z-0575-2022 · Jan 7, 2022 · Open, ClassifiedBaxter MiniCap Extended Life PD Transfer Set with Twist Clamp, REF R5C4482
Other SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE devices
- MiniCap 5C4482Baxter Healthcare Corporation · SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE3 recalls5 deaths2,961 reports
- MiniCap 5C4483Baxter Healthcare Corporation · SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE4 recalls433 reports
- Safe-Lock® 050-95018Fresenius Medical Care Holdings, Inc. · SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE2 recalls509 reports
- MINICAP WITH POVIDONE-IODINE SOLUTION 5C4466PBaxter Healthcare Corporation · SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE1 recall4 deaths347 reports
- MINICAP EXTENDED LIFE PD TRNS 5C4482ABaxter Healthcare Corporation · SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE193 reports
- UltraSet CAPD Disposable Disconnect Y-Set L5C4366Baxter Healthcare Corporation · SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE100 reports
- stay.safe® 050-95012Fresenius Medical Care Holdings, Inc. · SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE1 recall48 reports
- stay.safe® 050-95004Fresenius Medical Care Holdings, Inc. · SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE1 recall43 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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