MiniCapRecalls & reported problems across all models

We found 3 models of MiniCap by Baxter Healthcare Corporation in the FDA's device registry (GUDID). Together they are named in 3,423 adverse event reports in the FDA's MAUDE database, received between Jan 2, 2018 and Sep 22, 2026 — classified as 5 deaths, 86 injuries, 3,332 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1,234 reports).

7 FDA recall records name at least one of these models by its device identifier, 6 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

MiniCap recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

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-0563-2025 · Root cause: Under Investigation by firm · Recall details · 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-0562-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

3. 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 · Recall details · 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 · Recall details · FDA record ↗

5. 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 · Recall details · FDA record ↗

6. 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 · Recall details · FDA record ↗

7. Nov 10, 2020Terminated

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

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

Most reported MiniCap problems

MiniCap models

3 models, most reported first. Each model has its own page with its reports, recalls and device details.

• MiniCap 5C4482

  SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
  3 recalls5 deaths2,961 reports
• MiniCap 5C4483

  SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
  4 recalls433 reports
• MiniCap EZPC4466

  SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
  29 reports

Recent MiniCap adverse event reports

The 15 most recent reports across all models, 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 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 ↗
• 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 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 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 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 ↗
• 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 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 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 ↗

Other Baxter Healthcare Corporation products

• EXACTAMIX28 models · 6,739 reports · 13 recalls
• Novum IQ3 models · 1,540 reports · 7 recalls
• CLEARLINK/CONTINU-FLO/DUO-VENT3 models · 873 reports · 3 recalls
• CLEARLINK19 models · 710 reports · 4 recalls
• CLEARLINK/CONTINU-FLO8 models · 416 reports · 4 recalls
• CLEARLINK/DUO-VENT5 models · 282 reports · 1 recall
• REPEATER6 models · 189 reports
• DUO-VENT5 models · 31 reports · 2 recalls