MiniCap 5C4483Recalls & reported problems

Summary

The FDA's MAUDE database contains 433 adverse event reports that list this exact device (DI 00085412007748), received between Apr 10, 2018 and Sep 22, 2026 — classified as 10 injuries, 423 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (205 reports).

4 FDA recall records name this device's identifier, 4 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-0562-2025 · Root cause: Under Investigation by firm · FDA record ↗

2. 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-0563-2025 · Root cause: Under Investigation by firm · FDA record ↗

3. 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-0376-2025 · Root cause: Nonconforming Material/Component · FDA record ↗

4. 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-0377-2025 · Root cause: Nonconforming Material/Component · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 433 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2026Break

  It was reported that the twist clamp of a Minicap Transfer Set broke; described as the patient ¿had a transfer set change recently where the white twist part broke¿. This was identified during multiple steps 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 50854526 ↗
• MalfunctionJun 10, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT A MINICAP TRANSFER SET LEAKED AT THE TWIST CLAMP. THIS OCCURRED DURING THE FIRST EXCHANGE 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 25460910 ↗
• 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 PORTION OF THE TRANSFER SET WAS LOOSE AND ROTATING. THIS WAS IDENTIFIED DURING A TRANSFER SET CHANGE. THE TRANSFER SET WAS NOT USED AND WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25260369 ↗
• MalfunctionMay 20, 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; DESCRIBED AS ¿THE DARK BLUE PART GOT DISCONNECTED FROM THE BODY OF THE 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 25231191 ↗
• MalfunctionMay 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 OCCURRED WHEN DISCONNECTING FROM THE CYCLER AFTER PERITONEAL DIALYSIS THERAPY. THE PATIENT LINE WOULD NOT DISCONNECT INITIALLY. THE PATIENT NEEDED SOMETHING TO HELP THEM GRIP ONTO THE CONNECTIONS AND WAS EVENTUALLY ABLE TO DISCONNECT. 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 25203354 ↗
• MalfunctionMay 14, 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; DESCRIBED AS ¿THE NAVY BLUE THREADS ARE SEPARATING FROM THE LIGHT BLUE COMPONENT OF THE TRANSFER SET¿. THIS OCCURRED DURING USE OF THE DEVICE FOR PERITONEAL DIALYSIS THERAPY. THE TRANSFER SET HAD BEEN IN USE FOR ONE WEEK AT THE TIME OF THE EVENT. AS A RESULT, 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 25176287 ↗
• MalfunctionMay 12, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT A MINICAP TRANSFER HAD A SEPARATION ISSUE; DESCRIBED AS ¿THE DARK BLUE END PART GOT DISCONNECTED FROM THE BODY OF THE TRANSFER SET¿. THIS OCCURRED WHEN THE PATIENT WAS ABOUT TO DISCONNECT FROM THE PD CYCLER AFTER AN AUTOMATED PERITONEAL DIALYSIS (PD) THERAPY SESSION. AS A RESULT, 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 25153406 ↗
• MalfunctionMay 5, 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 25084122 ↗
• MalfunctionApr 20, 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 24925688 ↗
• MalfunctionApr 14, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THERE WAS A SEPARATION OF THE FEMALE CONNECTOR AND MAIN BODY OF THE MINICAP TRANSFER SET. THIS OCCURRED WHILE DISCONNECTING FROM THE CASSETTE AFTER PERITONEAL DIALYSIS THERAPY. THE PATIENT WAS UNABLE TO DISCONNECT FROM THE CASSETTE. THE TRANSFER SET HAD BEEN IN USE FOR FIVE DAYS 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 FIVE DAYS ORAL ANTIBIOTICS. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24876343 ↗
• MalfunctionApr 3, 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 WAS DESCRIBED AS ¿WHILE DISCONNECTING FORM A MANUAL BAG, THE BLUE THREADED CONNECTION SEPARATED FROM THE LIGHT BLUE PLASTIC WHILE UNSCREWING IT¿. THIS OCCURRED AFTER 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 24778710 ↗
• MalfunctionApr 2, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THERE WAS SEPARATION ISSUE WITH FEMALE CONNECTOR OF A MINICAP TRANSFER SET. THIS OCCURRED DURING USE OF THE DEVICE FOR CONTINUOUS AMBULATORY PERITONEAL DIALYSIS THERAPY. THE TRANSFER SET HAD BEEN IN USE FOR FOUR MONTHS AND WAS REPLACED BECAUSE OF THE ISSUE. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT, HOWEVER, UNSPECIFIED MEDICATION WAS GIVEN TO THE PATIENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24769262 ↗
• MalfunctionMar 31, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THERE WAS A SEPARATION BETWEEN THE TWIST CLAMP AND MAIN BODY OF THE MINICAP TRANSFER SET. THE CAP WAS SCREWING OFF THE SPRING MECHANISM. THE TRANSFER SET WAS REPLACED. 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 24741611 ↗
• InjuryMar 30, 2026Disconnection; Leak/Splash

  A PERITONEAL DIALYSIS (PD) PATIENT EXPERIENCED LEAKING FROM A TRANSFER SET. IT WAS FURTHER REPORTED THE TRANSFER SET DISCONNECTED FROM THE NON-VANTIVE PLASTIC ADAPTER. THE PATIENT WENT INTO THE CLINIC AFTER THE DISCONNECTION AND THE TRANSFER SET WAS REPLACED. SUBSEQUENTLY, THE PATIENT EXPERIENCED PERITONITIS AND WAS PRESCRIBED UNSPECIFIED INTRAPERITONEAL ANTIBIOTICS FOR THREE WEEKS. THE PATIENT WAS NOT HOSPITALIZED. ON AN UNSPECIFIED DATE, THE PATIENT RECOVERED FROM THE EVENT. ACTION TAKEN WITH PD THERAPY WAS NOT REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Peritonitis

  MAUDE report 24730475 ↗
• MalfunctionMar 30, 2026Fluid/Blood Leak

  IT WAS REPORTED THERE WAS LEAK A LEAK IN A MINICAP TRANSFER SET AND ¿ADAPTOR PARTS¿. THIS WAS FURTHER DESCRIBED AS THE LEAK OCCURRED ¿BETWEEN TITANIUM ADAPTER AND BEIGE CATHETER ADAPTER CONNECTER¿OF THE TRANSFER SET. THIS WAS OBSERVED DURING USE OF THE DEVICE FOR PERITONEAL DIALYSIS THERAPY. THE TITANIUM ADAPTER WAS NOT EXCHANGED. 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 24718886 ↗
• MalfunctionMar 26, 2026Difficult to Open or Close

  IT WAS REPORTED THAT THE TWIST CLAMP OF TWO (2) MINICAP TRANSFER SETS REMAINED PARTIALLY OPENED AND COULD NOT BE CLOSED. THIS WAS IDENTIFIED DURING USE OF THE DEVICES FOR 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 24703682 ↗
• MalfunctionMar 26, 2026Fluid/Blood Leak; Detachment of Device or Device Component

  IT WAS REPORTED THAT THERE WAS A SEPARATION BETWEEN THE PATIENT ADAPTER AND TUBING WITHIN THE MINICAP TRANSFER SET WHICH RESULTED IN A LEAK. THIS WAS OBSERVED 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 24703400 ↗
• MalfunctionMar 5, 2026Disconnection; Fluid/Blood Leak

  IT WAS REPORTED THAT THERE WAS A DISCONNECTION BETWEEN THE MINICAP TRANSFER SET AND TITANIUM ADAPTER WHICH RESULTED IN A LEAK. THIS OCCURRED DURING USE OF THE DEVICES FOR PERITONEAL DIALYSIS THERAPY. BOTH THE TRANSFER SET AND TITANIUM ADAPTER WERE REPLACED. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT; HOWEVER, THE PATIENT WAS TREATED WITH ANCEF 1.5G. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24519087 ↗
• MalfunctionFeb 3, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TWIST CLAMP SEPARATED FROM THE MAIN BODY OF THE MINICAP TRANSFER SET. THIS OCCURRED WHEN THE PATIENT ATTEMPTED TO TWIST THE CLAMP. 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 24247488 ↗
• MalfunctionFeb 3, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THERE WAS A SEPARATION BETWEEN THE TUBING AND TWIST CLAMP OF THE MINICAP TRANSFER SET. 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 24246391 ↗
• MalfunctionJan 23, 2026Break

  IT WAS REPORTED THAT THERE WAS AN UNSPECIFIED SEPARATION/CONNECTION ISSUE WITH THE MINICAP TRANSFER SET. THIS WAS IDENTIFIED AFTER PERITONEAL DIALYSIS THERAPY. THE PATIENT NOTICED THE TRANSFER SET WAS BROKEN. 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 24167394 ↗
• MalfunctionJan 20, 2026Fluid/Blood Leak; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE MINICAP TRANSFER SET CAME APART AT THE BLUE TUBING AREA WHICH RESULTED IN A LEAK. THE PATIENT WOKE UP WET. 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; HOWEVER, THE PATIENT WAS TREATED WITH PROPHYLACTIC ANTIBIOTICS. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24121986 ↗
• MalfunctionJan 5, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THE FEMALE CONNECTOR OF THE MINICAP TRANSFER SET SEPARATED. THIS OCCURRED DURING USE OF THE DEVICE FOR PERITONEAL DIALYSIS THERAPY. THE TRANSFER SET HAD BEEN IN USE FOR SEVEN 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 23956277 ↗
• MalfunctionDec 23, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THERE WAS A SEPARATION BETWEEN THE MAIN BODY AND TWIST CLAMP OF AN UNSPECIFIED QUANTITY OF MINICAP TRANSFER SETS. THE LIGHT BLUE PART DOES NOT CONNECT SECURELY TO THE WHITE PART. IT WOULD "POP" INTO PLACE BUT SLID OUT OF PLACE; IT WAS EXTREMELY LOOSE AND EASY TO TURN. THIS WAS IDENTIFIED BEFORE USE OF THE DEVICES FOR PERITONEAL DIALYSIS THERAPY. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23879823 ↗
• MalfunctionDec 23, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THERE WAS A SEPARATION BETWEEN THE MAIN BODY AND TWIST CLAMP OF AN UNSPECIFIED QUANTITY OF MINICAP TRANSFER SETS. THE LIGHT BLUE PART DOES NOT CONNECT SECURELY TO THE WHITE PART. IT WOULD "POP" INTO PLACE BUT SLID OUT OF PLACE; IT WAS EXTREMELY LOOSE AND EASY TO TURN. THIS WAS IDENTIFIED BEFORE USE OF THE DEVICES FOR PERITONEAL DIALYSIS THERAPY. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23879753 ↗