MINICAP WITH POVIDONE-IODINE SOLUTION 5C4466PRecalls & reported problems

Summary

The FDA's MAUDE database contains 347 adverse event reports that list this exact device (DI 00085412007694), received between Feb 16, 2018 and Aug 12, 2026 — classified as 4 deaths, 47 injuries, 296 malfunctions.

The most frequently reported specific device problem is “Product Quality Problem” (148 reports).

1 FDA recall record name this device's identifier, 1 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Feb 1, 2023Class IIOpen, Classified

   MiniCap Disconnect Cap with Povidone-Iodine are packaged in foil pouches, which may have been incorrectly sealed, i.e., the pouches may have open or weak seals. This could lead to exposure to air, resulting in insufficient iodine/dry sponge inside the MiniCap, which could lead to the potential for inadequate disinfectant.

   Z-1213-2023 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 347 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 12, 2026Product Quality Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50224309 ↗
• MalfunctionMay 29, 2026Product Quality Problem

  IT WAS REPORTED THAT THE SPONGE OF AN UNSPECIFIED QUANTITY OF MINICAPS WAS DRIED OUT. THIS WAS IDENTIFIED BEFORE 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 25331560 ↗
• MalfunctionMay 29, 2026Product Quality Problem

  IT WAS REPORTED THAT THE SPONGE OF AN UNSPECIFIED QUANTITY OF MINICAPS WAS DRIED OUT. THIS WAS IDENTIFIED BEFORE 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 25331485 ↗
• MalfunctionMay 29, 2026Product Quality Problem

  IT WAS REPORTED THAT THE SPONGE OF AN UNSPECIFIED QUANTITY OF MINICAPS WAS DRIED OUT. THIS WAS IDENTIFIED BEFORE 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 25331479 ↗
• MalfunctionMay 5, 2026Product Quality Problem

  IT WAS REPORTED THAT THE SPONGE OF AN UNSPECIFIED QUANTITY OF MINICAPS WERE DRY. 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 25081739 ↗
• MalfunctionMay 4, 2026Product Quality Problem

  IT WAS REPORTED THAT THE SPONGE OF AN UNSPECIFIED QUANTITY OF MINICAPS WERE DRY. 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 25071717 ↗
• MalfunctionApr 14, 2026Product Quality Problem

  IT WAS REPORTED THAT THE SPONGE OF AN UNSPECIFIED QUANTITY OF MINICAPS HAD INADEQUATE IODINE. THIS WAS IDENTIFIED BEFORE 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 24873102 ↗
• MalfunctionApr 14, 2026Product Quality Problem

  IT WAS REPORTED THAT THE SPONGE OF AN UNSPECIFIED QUANTITY OF MINICAPS HAD INADEQUATE IODINE. THIS WAS IDENTIFIED BEFORE 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 24873054 ↗
• MalfunctionDec 17, 2025Product Quality Problem; Product Quality Problem

  IT WAS REPORTED THAT SIX (6) MINICAPS DID NOT HAVE IODINE SOLUTION. THIS WAS IDENTIFIED WHEN OPENING THE PACKAGING, BEFORE 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 23831557 ↗
• MalfunctionDec 5, 2025Product Quality Problem; Product Quality Problem

  IT WAS REPORTED THAT THE IODINE SOLUTION IN AN UNSPECIFIED QUANTITY OF MINICAPS WAS DRIED OUT. THIS WAS IDENTIFIED BEFORE 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 23732655 ↗
• MalfunctionDec 5, 2025Product Quality Problem; Product Quality Problem

  IT WAS REPORTED THAT THE IODINE SOLUTION WAS NOT PRESENT IN AN UNSPECIFIED QUANTITY OF MINICAPS. THE CAPS WERE DRY. THIS WAS IDENTIFIED BEFORE 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 23728892 ↗
• MalfunctionNov 26, 2025Product Quality Problem; Packaging Problem; Product Quality Problem; Packaging Problem

  IT WAS REPORTED THAT THE IODINE SPONGE OF AN UNSPECIFIED QUANTITY OF MINICAPS WERE DRY AND THE FOIL PACKAGING WAS CRUSHED. THIS WAS IDENTIFIED 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 23658573 ↗
• MalfunctionNov 21, 2025Product Quality Problem; Product Quality Problem

  IT WAS REPORTED THAT THE IODINE IN AN 50 UNITS OF MINICAPS WAS DRIED OUT. THIS WAS IDENTIFIED BEFORE 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 23619479 ↗
• MalfunctionNov 19, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF MINICAPS WERE CRUSHED. THIS WAS IDENTIFIED BEFORE 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 23596384 ↗
• MalfunctionNov 18, 2025Product Quality Problem; Product Quality Problem

  IT WAS REPORTED THAT THE SPONGE OF AN UNSPECIFIED QUANTITY OF MINICAPS WERE DRY AND DAMAGED. THIS WAS IDENTIFIED BEFORE 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 23586940 ↗
• MalfunctionNov 17, 2025Break; Break

  IT WAS REPORTED THAT FIFTY (50) UNITS OF MINICAPS WERE DAMAGED. THIS WAS DESCRIBED AS ¿THE PATIENT UNABLE TO CONNECT THE MINICAP PORT DUE TO DAMAGE¿. THIS WAS OBSERVED BEFORE 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 23573919 ↗
• MalfunctionNov 13, 2025Product Quality Problem; Product Quality Problem

  IT WAS REPORTED THAT THERE WAS LITTLE TO NO IODINE IN AN UNSPECIFIED QUANTITY OF MINICAPS. 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 23544269 ↗
• MalfunctionNov 5, 2025Product Quality Problem; Product Quality Problem

  IT WAS REPORTED THAT THE SPONGE OF TEN (10) UNITS OF MINICAPS WERE DRIED OUT WITH A BROWNISH COLOR; DESCRIBED AS THE MINICAPS "DO NOT HAVE ANY SOLUTION IN THEM¿. THIS OCCURRED BEFORE 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 23480738 ↗
• MalfunctionNov 3, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT PARTICULATE MATTER DESCRIBED AS ¿A LARGE REDDISH CLUMP¿ WAS OBSERVED INSIDE AN UNSPECIFIED QUANTITY OF MINICAPS. THIS WAS IDENTIFIED BEFORE 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 23452263 ↗
• MalfunctionOct 28, 2025Product Quality Problem; Product Quality Problem

  IT WAS REPORTED THAT THE SPONGE OF ELEVEN (11) MINICAPS WERE WHITE AND DRIED OUT. 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 23404820 ↗
• MalfunctionOct 27, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY [AT LEAST THREE (3)] MINICAPS LEAKED IODINE. THERE WAS NO DAMAGE OBSERVED. THIS OCCURRED AFTER CONNECTING THE MINICAPS TO THE TRANSFER SET. THE ¿CHEMICAL¿ (IODINE) WAS SPLASHING ALL AROUND THE AREA. 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 23390709 ↗
• MalfunctionSep 17, 2025Product Quality Problem; Product Quality Problem

  IT WAS REPORTED THAT THERE WAS NO BETADINE IN AN UNSPECIFIED QUANTITY [AT LEAST TWENTY (20)] OF MINICAPS. THIS WAS IDENTIFIED BEFORE 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 23076835 ↗
• InjurySep 16, 2025Improper or Incorrect Procedure or Method; Device Damaged Prior to Use; Improper or Incorrect Procedure or Method; Device Damaged Prior to Use

  IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT EXPERIENCED AN UNSPECIFIED INFECTION AFTER THE PATIENT USED MINICAPS THAT WERE RECEIVED "DEFECTIVE". THIS WAS FURTHER DESCRIBED AS "'PACKAGE/BOX OPEN OR DAMAGED BEFORE USE". IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED FOR THREE DAYS FOR THE EVENT. TREATMENT FOR THE INFECTION WAS NOT REPORTED. AT THE TIME OF THIS REPORT, THE PATIENT OUTCOME WAS NOT REPORTED. PD THERAPY WAS DISCONTINUED, THE PD CATHETER WAS REMOVED, AND THE PATIENT WAS TRANSFERRED TO HEMODIALYSIS. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 23066563 ↗
• MalfunctionSep 9, 2025Product Quality Problem; Product Quality Problem

  IT WAS REPORTED THAT THE SPONGES OF TWENTY (20) MINICAPS WERE "DRIED OUT AND WHITE"; IT WAS FURTHER STATED "THE PACKAGE/BOX WAS OPEN OR DAMAGED BEFORE USE". THIS OCCURRED 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 23006832 ↗
• MalfunctionSep 8, 2025Crack; Crack

  IT WAS REPORTED THAT THE SIDE OF A MINICAP WAS CRACKED WHICH CAUSED IODINE TO LEAK OUT. THIS 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 22999464 ↗