FOGARTY 120404FRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00690103043266), received between Jun 19, 2024 and Jan 10, 2025 — 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. How this data works · Data updated Oct 13, 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.

• MalfunctionJan 10, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT BEFORE USE DURING THE INFLATION TEST, THE TIP OF THIS FOGARTY CATHETER WAS DETACHED WHEN THE BALLOON WAS INFLATED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21126728 ↗
• MalfunctionOct 11, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE FOGARTY CATHETER WAS BROKEN DURING USE. THE DETAILED INFORMATION ON THE LOCATION AND CONDITION OF THE DAMAGE WERE NOT AVAILABLE. NO ADDITIONAL INTERVENTION SUCH AS ADDITIONAL INCISION WAS PERFORMED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20433849 ↗
• MalfunctionJun 19, 2024Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT THE BALLOON OF A VASCULAR CATHETER DID NOT DEFLATE. STAFF HAD TO PUNCTURE THE BALLOON THROUGH THE SKIN TO DEFLATE BALLOON. THERE WERE NO PATIENT INJURIES. A PRODUCT EVALUATION WAS COMPLETED ON THE RETURNED 120404F CATHETER. THE CUSTOMER REPORTED OF "DID NOT DEFLATE" WAS UNABLE TO BE CONFIRMED. AS RECEIVED, BALLOON WAS RECEIVED RUPTURED. BALLOON LATEX WAS RELEASED FROM PROXIMAL WINDING TO CHECK BALLOON EDGES. THE EDGES DID NOT APPEAR TO MATCH AT THE RUPTURE. THE PROXIMAL WINDING HAD PARTIALLY UNRAVELED AND SLIPPED DISTAL ON THE CATHETER TIP. BOTH BALLOON AND PART OF THE PROXIMAL WINDING HAD SLIPPED DISTAL OF THE INFLATION PORTS. BALLOON MAY BE UNABLE TO DEFLATE WHEN SLIPPED DISTAL OF THE INFLATION PORTS. DISTAL WINDING WAS INTACT. NO VISIBLE DAMAGE WAS OBSERVED FROM CATHETER BODY. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND DOCUMENTED THAT DEVICE MET ALL SPECIFICATIONS UPON DISTRIBUTION. AN ENGINEERING EVALUATION WAS INITIATED TO ASSESS FOR ANY MANUFACTURING RELATED PROCESSES WHICH COULD BE CORRELATED TO THE COMPLAINT. BASED ON THE AVAILABLE INFORMATION, THERE IS NO EVIDENCE THAT SUPPORTS OR CONFIRMS THE FAILURE MODE IS ASSOCIATED TO A MANUFACTURING OR DESI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19567063 ↗