MINICAP EXTENDED LIFE PD TRNS 5C4482ARecalls & reported problems

Summary

The FDA's MAUDE database contains 193 adverse event reports that list this exact device (DI 00085412841625), received between Dec 27, 2024 and Sep 23, 2026 — classified as 12 injuries, 181 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (119 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 193 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2026Loose or Intermittent Connection

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50875449 ↗
• InjurySep 21, 2026Disconnection

  Patient problems: Peritonitis

  MAUDE report 50847663 ↗
• MalfunctionJun 24, 2026Failure to Disconnect

  IT WAS REPORTED THAT THERE WAS A CONNECTION ISSUE BETWEEN THE MINICAP TRANSFER SET AND CASSETTE. THE PATIENT LINE OF THE CASSETTE WOULD NOT DISCONNECT FROM THE TRANSFER SET. THE PATIENT HAD TO CUT THE PATIENT LINE TO DISCONNECT. 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; HOWEVER, THE PATIENT WAS TREATED WITH PROPHYLACTIC ANTIBIOTICS. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25607318 ↗
• MalfunctionJun 12, 2026Disconnection; Free or Unrestricted Flow

  IT WAS REPORTED THAT THE MINICAP TRANSFER SET LEAKED WITH THE TWIST CLAMP CLOSED. FLUID WAS DRIPPING OUT OF BLUE TIP (FEMALE CONNECTOR) DESPITE THE TRANSFER SET TWIST CLAMP BEING TWISTED TO THE OFF POSITION. THIS OCCURRED AFTER DISCONNECTION FROM THE CYCLER PATIENT LINE AFTER PERITONEAL DIALYSIS THERAPY. THE TRANSFER SET HAD BEEN IN USE FOR ONE WEEK AND 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 25484366 ↗
• MalfunctionJun 8, 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 HAD BEEN IN USE FOR ONE MONTH. 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 25430251 ↗
• InjuryMay 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT WAS UNABLE TO COMPLETE DIALYSIS WHILE USING A MINICAP EXTEND LIFE PD TRANSFER SET REPORTEDLY DUE TO UNSPECIFIED "MULTIPLE MACHINE ALARMS". THE PATIENT PRESENTED TO THE CLINIC FOR ASSESSMENT. IT WAS REPORTED THAT THE PATIENT DRAINED "CLEAR YELLOW EFFLUENT". THE PATIENT WAS TREATED WITH PROPHYLACTIC ANTIBIOTIC THERAPY. THE TRANSFER SET WAS REPLACED. THERE WAS NO REPORT OF HOSPITALIZATION. AT THE TIME OF THIS REPORT, THE PATIENT OUTCOME AND ACTION TAKEN WITH PD THERAPY WAS NOT REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 25276553 ↗
• MalfunctionMay 22, 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. THE BLUE PART CAME OUT OF THE TRANSFER SET. THIS OCCURRED WHEN DISCONNECTING FROM THE PATIENT LINE AFTER PERITONEAL DIALYSIS THERAPY. THE PATIENT COULD NOT DISCONNECT THE TRANSFER SET FROM THE PATIENT LINE AND WENT TO THE CLINIC TO DISCONNECT. 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 25260420 ↗
• MalfunctionMay 22, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT A MINICAP TRANSFER SET LEAKED IODINE. THIS OCCURRED DURING USE OF THE DEVICE FOR PERITONEAL DIALYSIS THERAPY. THE TRANSFER SET WAS REPLACED AND THE ISSUE RESOLVED. 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 25257749 ↗
• MalfunctionMay 12, 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 CHANGE. THE TRANSFER SET WAS NEW. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25149966 ↗
• MalfunctionApr 21, 2026Failure to Disconnect

  IT WAS REPORTED THAT THERE WAS A CONNECTION ISSUE BETWEEN THE PATIENT LINE OF THE AMIA CASSETTE AND MINICAP TRANSFER SET. THE FEMALE CONNECTOR OF THE TRANSFER SET REMAINED ¿STUCK¿ TO THE PATIENT LINE OF THE CASSETTE. 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 24942041 ↗
• MalfunctionApr 9, 2026Difficult to Open or Close

  IT WAS REPORTED THAT THE TWIST CLAMP OF A MINICAP TRANSFER SET WAS NOT ABLE TO BE CLOSED COMPLETELY. THIS WAS FURTHER DESCRIBED AS, THE "NURSE TRIED VERY HARD BUT SEEMS CAN¿T BE CLOSED COMPLETELY¿. THIS OCCURRED ¿AFTER EXCHANGING TO THE PATIENT¿ BEFORE USE 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 24834428 ↗
• MalfunctionApr 9, 2026Difficult to Open or Close

  IT WAS REPORTED THAT THE TWIST CLAMP OF A MINICAP TRANSFER SET COULD NOT BE CLOSED. THE EVENT WAS FURTHER DESCRIBED AS "THE TWIST CLAMP WAS SO TIGHT THAT THE TRANSFER SET WAS NOT ABLE TO CLOSE AT ALL." THIS WAS OBSERVED BEFORE USE OF THE DEVICE FOR PERITONEAL DIALYSIS THERAPY; STATED AS "SET HAD BEEN IN USE OF ZERO(0) DAY". THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24831991 ↗
• MalfunctionApr 9, 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. 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 24829424 ↗
• MalfunctionApr 2, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THERE WAS A SEPARATION BETWEEN THE MAIN BODY AND TWIST CLAMP OF THE MINICAP TRANSFER SET. 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 24765833 ↗
• MalfunctionApr 1, 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 CHANGE, PRIOR TO PATIENT CONNECTION. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24757203 ↗
• MalfunctionApr 1, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THERE WAS A SEPARATION ISSUE WITH A MINCAP TRANSFER SET. THE MIDDLE PORTION WAS FOUND OPENED. 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 24753789 ↗
• MalfunctionMar 30, 2026Failure to Disconnect

  IT WAS REPORTED THAT THERE WAS A CONNECTION ISSUE BETWEEN THE MINICAP TRANSFER SET AND ULTRABAG. THE TRANSFER SET COULD NOT BE DETACHED FROM THE BAG. 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 24713444 ↗
• MalfunctionMar 20, 2026Difficult to Open or Close

  IT WAS REPORTED THAT THE TWIST CLAMP OF THE MINICAP TRANSFER SET COULD NOT BE CLOSED. THIS OCCURRED DURING AN UNSPECIFIED 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 24649553 ↗
• MalfunctionMar 12, 2026Break

  IT WAS REPORTED THAT THE TWIST CLAMP OF THE MINICAP TRANSFER SET WAS BROKEN. THE BLUE MAIN BODY PLASTIC PIECE INSIDE THE TWIST CLAMP WAS BROKEN WHICH ALLOWED THE TWIST CLAMP TO SLIDE ALONG THE TRANSFER SET TUBING. 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 24579531 ↗
• MalfunctionMar 12, 2026Break

  IT WAS REPORTED THAT THE TWIST CLAMP OF THE MINICAP TRANSFER SET BROKE. 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, HOWEVER THE PATIENT WAS TREATED WITH INTRAPERITONEAL (IP) 2GM CEFTAZIDIME AND 1GM VANCOMYCIN. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24578486 ↗
• MalfunctionMar 6, 2026Free or Unrestricted Flow

  IT WAS REPORTED THAT THERE WAS FLUID FLOW WITH THE TWIST CLAMP OF THE MINICAP TRANSFER SET IN THE CLOSED POSITION. THIS OCCURRED AFTER DISCONNECTING FROM THE CYCLER PATIENT LINE AFTER PERITONEAL DIALYSIS THERAPY. THERE WAS CLEAR FLUID DRIPPING FROM THE END OF THE CLOSED TRANSFER SET. THE PATIENT CONNECTED A MINICAP ON THE FEMALE CONNECTOR OF THE TRANSFER SET. 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 24530517 ↗
• MalfunctionFeb 19, 2026Fluid/Blood Leak; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TWIST CLAMP OF THE MINICAP TRANSFER SET WAS BROKEN WHICH RESULTED IN A LEAK. WHEN THE TWIST CLAMP IS OPENED, IT ¿DISCONNECTS AND CONTINUOUSLY ROLLS.¿ THE EVENT 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 24389040 ↗
• MalfunctionFeb 17, 2026Disconnection; Fluid/Blood Leak

  IT WAS REPORTED THAT THREE (3) MINICAPS TRANSFER SETS DISCONNECTED AT AN UNSPECIFIED LOCATION WHICH RESULTED IN A LEAK. THE PATIENTS HAD HUGE LEAKS ON THEIR PANTS AND CLOTHING. FOR TWO PATIENTS THE EVENT OCCURRED WHILE CUTTING THEIR FRONT YARD GRASS. FOR ONE PATIENT THE EVENT OCCURRED WHILE PREPARING THEIR MEAL. 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 24365801 ↗
• MalfunctionFeb 16, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THE SILICONE ¿TUBING EASILY SEPARATED FROM THE PATIENT CONNECTOR" OF A MINICAP TRANSFER SET. THIS OCCURRED WHEN THE ¿PD NURSE TESTED A NEW TRANSFER SET¿. THIS OCCURRED PRIOR TO PATIENT USE FOR PERITONEAL DIALYSIS (PD) THERAPY. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24344675 ↗
• MalfunctionFeb 13, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THE FEMALE CONNECTOR OF THE MINICAP TRANSFER SET WAS BROKEN. THERE WAS A SEPARATION ISSUE WITH THE FEMALE CONNECTOR WHEN DISCONNECTING FROM THE CYCLER PATIENT LINE AFTER PERITONEAL DIALYSIS THERAPY. THE PATIENT WAS ABLE TO DISCONNECT SAFELY. 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 24334825 ↗