Dover 7006LLRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884521001237), received between Jul 6, 2020 and Jun 27, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 27, 2023Material Rupture; Material Rupture

  CUSTOMER REPORTS: THE FOLEY BALLOON BURST. PER ADDITIONAL INFORMATION RECEIVED ON (B)(6)23, THE BALLOON BURSTS OCCURRED WITH THE SAME PATIENT. FIVE HOURS AFTER THE 4TH FOLEY WAS REPLACED, THE BALLOON POPPED AGAIN. PATIENT WENT TO AKRON BATH THEY PUT IN AN 18F FOLEY WHICH POPPED AN HOUR LATER. SHE THEN RETURNED TO MEDINA. UROLOGY THOUGHT IT COULD BE RELATED TO A BLADDER STONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17211047 ↗
• MalfunctionJul 20, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THE FOLEY DISCONNECTED AT THE SEAL AT THE JUNCTION OF THE CATHETER AND TUBE CONNECTION POINT. THE FOLEY WAS REPLACED AND THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10295224 ↗
• MalfunctionJul 6, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THE FOLEY BECAME DISCONNECTED AT THE SEAL AT THE JUNCTION OF THE CATHETER AND TUBE CONNECTION POINT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10235494 ↗