MiniCap 5C4482Recalls & reported problems

Summary

The FDA's MAUDE database contains 2,961 adverse event reports that list this exact device (DI 00085412007731), received between Jan 2, 2018 and Jun 25, 2026 — classified as 5 deaths, 76 injuries, 2,880 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1,027 reports).

3 FDA recall records name this device's identifier, 2 still open.

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.

Recalls naming this device

1. Oct 23, 2024Open, Classified

   There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set.

   Z-0559-2025 · Root cause: Under Investigation by firm · FDA record ↗

2. Oct 21, 2024Open, Classified

   Baxter is aware of several recalls by other manufacturers related to the potential risk of exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated biphenyls (PCBs) when using certain peritoneal dialysis and hemodialysis devices.

   Z-0373-2025 · Root cause: Nonconforming Material/Component · FDA record ↗

3. Nov 10, 2020Terminated

   Potential for no-flow and leaks under the twist clamp.

   Z-0768-2021 · Root cause: Process change control · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 2,961 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 25, 2026Free or Unrestricted Flow

  IT WAS REPORTED THAT THE MINICAP TRANSFER SET LEAKED AFTER THE ¿SWITCH¿ WAS TIGHTENED AND IN PLACE. THIS OCCURRED DURING USE OF THE DEVICE FOR PERITONEAL DIALYSIS THERAPY. THE TRANSFER SET HAD BEEN IN USE FOR THREE MONTHS. 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 25620288 ↗
• MalfunctionMay 19, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THERE WAS A SEPARATION BETWEEN THE FEMALE CONNECTOR AND THE MAIN BODY OF A MINICAP TRANSFER SET. THIS OCCURRED DURING USE OF THE DEVICE FOR PERITONEAL DIALYSIS THERAPY. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25217974 ↗
• MalfunctionMay 13, 2026Free or Unrestricted Flow

  IT WAS REPORTED THAT A MINICAP TRANSFER SET LEAKED WITH THE TWIST CLAMP CLOSED. THIS OCCURRED DURING USE OF THE DEVICE FOR 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 25165083 ↗
• MalfunctionMay 13, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT A MINICAP TRANSFER SET HAD IODINE LEAKAGE. 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 25164775 ↗
• MalfunctionApr 28, 2026Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THERE WAS A SLIT IN THE PAPER SIDE OF THE PACKAGING OF THE MINICAP TRANSFER SET. THIS WAS IDENTIFIED BEFORE 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 25019818 ↗
• MalfunctionApr 24, 2026Difficult to Open or Close

  IT WAS REPORTED THAT THE TWIST CLAMP OF THE MINICAP TRANSFER SET COULD NOT BE CLOSED. THIS WAS IDENTIFIED DURING A TRANSFER SET REPLACEMENT. A NEW TRANSFER SET WAS USED. 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 24985049 ↗
• MalfunctionApr 16, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THERE WAS A SEPARATION BETWEEN THE FEMALE CONNECTOR AND MAIN BODY OF THE MINICAP TRANSFER SET. THIS OCCURRED WHEN DISCONNECTING FROM A TWIN BAG AFTER PERITONEAL DIALYSIS THERAPY. THE TRANSFER SET WAS REPLACED BECAUSE OF THE ISSUE. 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 24896573 ↗
• MalfunctionMar 31, 2026Crack

  IT WAS REPORTED THAT THE PATIENT CONNECTOR OF THE MINICAP TRANSFER SET WAS CRACKED. THIS WAS IDENTIFIED WHEN CONNECTING THE TRANSFER SET TO THE PATIENT. 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 24741827 ↗
• MalfunctionMar 31, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THERE WAS A SEPARATION BETWEEN THE FEMALE CONNECTOR AND MAIN BODY OF THE MINICAP TRANSFER SET. THIS OCCURRED DURING USE OF THE DEVICE FOR PERITONEAL DIALYSIS THERAPY. THE TRANSFER SET HAD BEEN IN USE FOR SIX DAYS AND WAS REPLACED BECAUSE OF THE ISSUE. 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 24741822 ↗
• MalfunctionMar 30, 2026Difficult to Open or Close

  IT WAS REPORTED THAT THE TWIST CLAMP OF THE MINICAP TRANSFER SET COULD NOT BE CLOSED. 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 24730431 ↗
• MalfunctionMar 30, 2026Difficult to Open or Close

  IT WAS REPORTED THAT THE TWIST CLAMP OF THE MINICAP TRANSFER SET COULD NOT BE CLOSED. THIS WAS IDENTIFIED 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 24717115 ↗
• MalfunctionMar 26, 2026Unsealed Device Packaging

  IT WAS REPORTED THAT ONE END OF THE SEAL OF THE OUTER PACKAGING OF THE MINICAP TRANSFER SET WAS OPENED. THIS WAS OBSERVED 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 24702925 ↗
• MalfunctionMar 24, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT A MINICAP TRANSFER SET LEAKED FROM AN UNSPECIFIED LOCATION; DESCRIBED AS ¿A LEAK DUE TO VALVE FAILURE WAS OBSERVED¿. THIS WAS IDENTIFIED WHILE THE PATIENT WAS UNDERGOING PERITONEAL DIALYSIS THERAPY. THE TRANSFER SET WAS REPLACED. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT, HOWEVER, THE PATIENT WAS ADMINISTERED ANTIBIOTICS PROPHYLACTICALLY. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24675538 ↗
• MalfunctionMar 23, 2026Disconnection

  IT WAS REPORTED THAT A MINICAP TRANSFER SET DISCONNECTED FROM AN UNSPECIFIED DEVICE. THIS WAS DESCRIBED AS "THE TRANSFER SET CAME OFF". IT WAS STATED THAT THE PATIENT WAS DISCONNECTED FROM TREATMENT, HOWEVER, WAS CONNECTED TO THE TRANSFER SET AT THE TIME OF THE EVENT. THE EVENT OCCURRED BEFORE 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 24666557 ↗
• MalfunctionMar 10, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THERE WAS A SEPARATION BETWEEN THE FEMALE CONNECTOR AND MAIN BODY OF THE MINICAP TRANSFER SET. THIS OCCURRED DURING USE OF THE DEVICE FOR PERITONEAL DIALYSIS THERAPY. THE TRANSFER SET WAS REPLACED BECAUSE OF THE ISSUE. 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 24557819 ↗
• MalfunctionMar 4, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THERE WAS A GAP AT THE JUNCTION OF THE EXTERNAL SHORT TUBE AND THE KNOB OF THE MINICAP TRANSFER SET; FURTHER DESCRIBED AS ¿CANNOT FIT TIGHTLY.¿ 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 24512779 ↗
• MalfunctionMar 4, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THERE WAS A SEPARATION BETWEEN THE PATIENT CONNECTOR AND TUBING OF THE MINICAP TRANSFER SET. 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 24507326 ↗
• MalfunctionFeb 24, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THERE WAS A SEPARATION BETWEEN THE FEMALE CONNECTOR AND THE MAIN BODY OF A MINICAP TRANSFER SET. THE ISSUE WAS DESCRIBED AS "THE PATIENT'S EXTERNAL SHORT TUBE'S THREADED CONNECTOR BECAME LOOSE". THIS OCCURRED BEFORE USE OF THE DEVICE FOR 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 24430512 ↗
• MalfunctionFeb 23, 2026Fluid/Blood Leak; Air/Gas in Device

  IT WAS REPORTED THAT ¿BUBBLES ALWAYS APPEAR AT THE SHORT TUBE CONNECTION¿ OF A MINICAP TRANSFER SET.THIS OCCURRED DURING USE OF THE DEVICE FOR AUTOMATED PERITONEAL DIALYSIS (PD) THERAPY. THIS WAS FURTHER DESCRIBED AS ¿AIR BUBBLE IS AT FEMALE CONNECTOR¿. THE PROBLEM WAS SOLVED BY REPLACING THE TRANSFER SET.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 24421889 ↗
• MalfunctionFeb 18, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THERE WAS A SEPARATION BETWEEN THE FEMALE CONNECTOR AND MAIN BODY OF THE MINICAP TRANSFER SET. 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 24377588 ↗
• MalfunctionFeb 13, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THE MINICAP TRANSFER SET DISCONNECTED WHICH RESULTED IN A LEAK. THE PATIENT HAD LEAKS ON THEIR CLOTHING. 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 24332718 ↗
• MalfunctionFeb 12, 2026Free or Unrestricted Flow

  IT WAS REPORTED THAT THERE WAS FLUID FLOW WITH THE TWIST CLAMP OF THE MINICAP TRANSFER SET CLOSED. 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 24323443 ↗
• MalfunctionFeb 11, 2026Detachment of Device or Device Component

  DURING EVALUATION, A SEPARATION BETWEEN THE TUBING AND THE TWIST CLAMP OF THE MINICAP TRANSFER SET WAS OBSERVED. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24316088 ↗
• MalfunctionFeb 11, 2026Free or Unrestricted Flow

  IT WAS REPORTED THAT THE MINICAP TRANSFER SET LEAKED WITH THE TWIST CLAMP CLOSED. THIS OCCURRED DURING USE OF THE DEVICE FOR 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 24314501 ↗
• MalfunctionFeb 9, 2026Difficult to Open or Close

  IT WAS REPORTED THAT THE TWIST CLAMP OF THREE (3) MINICAP TRANSFER SETS DID NOT CLOSE. THERE WERE GAPS AT THE TWIST CLAMP. THIS WAS IDENTIFIED DURING TRANSFER SET REPLACEMENT. 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 24293162 ↗