MiniCap 5C4449Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00085412050867), received between Jul 5, 2019 and Aug 13, 2025 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (4 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 13, 2025Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  IT WAS REPORTED THAT THE TWIST CLAMP OF THE MINICAP TRANSFER SET BROKE WHICH RESULTED IN A LEAK. THIS OCCURRED DURING USE OF THE DEVICE 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 22800069 ↗
• MalfunctionSep 6, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THERE WAS A SEPARATION BETWEEN THE FEMALE CONNECTOR AND MAIN BODY OF A MINICAP TRANSFER SET; FURTHER DESCRIBED AS "PATIENT'S BLUE CONNECTOR ON THE TRANSFER SET FELL APART." THIS OCCURRED DURING AN UNSPECIFIED PROCESS STEP OF PERITONEAL DIALYSIS THERAPY. THE TRANSFER SET WAS REPLACED. 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 20157460 ↗
• MalfunctionSep 6, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THERE WAS A SEPARATION BETWEEN THE FEMALE CONNECTOR AND MAIN BODY OF A MINICAP TRANSFER SET; FURTHER DESCRIBED AS "PATIENT'S BLUE CONNECTOR ON THE TRANSFER SET FELL APART." THIS OCCURRED DURING AN UNSPECIFIED PROCESS STEP OF 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 20156230 ↗
• MalfunctionSep 5, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THERE WAS A SEPARATION BETWEEN THE FEMALE CONNECTOR (BLUE CONNECTOR) AND THE MAIN BODY OF THREE (3) MINICAP TRANSFER SETS; FURTHER DESCRIBED AS ¿PATIENT'S BLUE CONNECTOR ON THE TRANSFER SET FELL APART¿. THIS OCCURRED DURING AN UNSPECIFIED PROCESS STEP OF PERITONEAL DIALYSIS THERAPY. THE TRANSFER SETS WERE REPLACED. 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 20147446 ↗
• MalfunctionOct 31, 2022Manufacturing, Packaging or Shipping Problem

  MINICAP EXTENDED LIFE PD (PERITONEAL DIALYSIS) TRANSFER SET CAN BE DAMAGED IF IT COMES INTO CONTACT WITH CLEANING PRODUCTS OR SOLVENTS. FDA SAFETY REPORT ID #(B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15708228 ↗
• MalfunctionOct 26, 2022No Apparent Adverse Event

  WE WERE NOTIFIED NOT TO CLEAN 5C4449 TRANSFER SETS WITH CERTAIN SOLVENTS. WE HAVE NOT USED ANY OF THE SOLVENTS WHICH WE MENTIONED. FDA SAFETY REPORT ID #(B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15679933 ↗
• MalfunctionApr 16, 2021Fluid/Blood Leak; Material Split, Cut or Torn; Fluid/Blood Leak; Material Split, Cut or Torn

  IT WAS REPORTED THAT A MINICAP EXTENDED LIFE PD TRANSFER SET LEAKED; FURTHER DESCRIBED AS ¿SOLUTION BEGAN TO SPRAY FROM THE TRANSFER SET¿. THIS WAS OBSERVED DURING USE OF THE DEVICE FOR PERITONEAL DIALYSIS THERAPY. IT WAS FURTHER REPORTED THE NURSE DISCOVERED A "SLICE ON THE TUBING¿. THE TRANSFER SET WAS REPLACED. THERE WAS NO REPORT OF PATIENT INJURY; HOWEVER, THE PATIENT WAS GIVEN PROPHYLACTIC ANTIBIOTICS AS A PRECAUTIONARY MEASURE. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11682171 ↗
• MalfunctionJan 21, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A MINICAP TRANSFER SET LEAKED FROM AN UNSPECIFIED LOCATION; FURTHER DESCRIBED AS ¿SOMEWHERE ALONG THE TRANSFER SET, THERE WAS A SLOW LEAK.¿ THIS OCCURRED WHEN THE PATIENT FLUSHED THE CATHETER USING A SYRINGE FILLED WITH NORMAL SALINE SOLUTION. THE TRANSFER SET WAS REPLACED. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11207532 ↗
• MalfunctionJul 5, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE CONNECTION BETWEEN THE MINICAP AND THE TRANSFER SET LEAKED. THIS WAS FOUND DURING PRODUCT TESTING. THE MINICAP WAS RE-TESTED WITH A NEW TRANSFER SET WITH NO ISSUE NOTED. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 8765323 ↗