Dover P4P16XTSRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10884521069060), received between Mar 12, 2021 and Apr 27, 2021 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (10 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 27, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THAT THE FOLEY CATHETER BECAME DISCONNECTED FROM THE CLOSED SYSTEM TRAY AFTER PLACEMENT IN THE PATIENT. THE DISCONNECTION HAPPENED NEAR THE TAMPER EVIDENT SEAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11731820 ↗
• MalfunctionApr 27, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THAT THE FOLEY CATHETER BECAME DISCONNECTED FROM THE CLOSED SYSTEM TRAY AFTER PLACEMENT IN THE PATIENT. THE DISCONNECTION HAPPENED NEAR THE TAMPER EVIDENT SEAL. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11731802 ↗
• MalfunctionMar 18, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THAT THE FOLEY DETACHED FROM THE CLOSED SYSTEM AT THE CONNECTION POINT, UNDER THE TAMPER EVIDENT SEAL. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11516514 ↗
• MalfunctionMar 18, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THAT THE FOLEY DETACHED FROM THE CLOSED SYSTEM AT THE CONNECTION POINT, UNDER THE TAMPER EVIDENT SEAL. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11516511 ↗
• MalfunctionMar 18, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THAT THE FOLEY DETACHED FROM THE CLOSED SYSTEM AT THE CONNECTION POINT, UNDER THE TAMPER EVIDENT SEAL. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11516508 ↗
• MalfunctionMar 18, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THAT THE FOLEY DETACHED FROM THE CLOSED SYSTEM AT THE CONNECTION POINT, UNDER THE TAMPER EVIDENT SEAL. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11516504 ↗
• MalfunctionMar 18, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THAT THE FOLEY DETACHED FROM THE CLOSED SYSTEM AT THE CONNECTION POINT, UNDER THE TAMPER EVIDENT SEAL. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11516502 ↗
• MalfunctionMar 18, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THAT THE FOLEY DETACHED FROM THE CLOSED SYSTEM AT THE CONNECTION POINT, UNDER THE TAMPER EVIDENT SEAL. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11516496 ↗
• MalfunctionMar 18, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THAT THE FOLEY DETACHED FROM THE CLOSED SYSTEM AT THE CONNECTION POINT, UNDER THE TAMPER EVIDENT SEAL. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11516389 ↗
• MalfunctionMar 12, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THAT THE FOLEY DETACHES FROM THE CLOSED SYSTEM AT THE CONNECTION POINT, UNDER THE TAMPER EVIDENT SEAL. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11477360 ↗