Fogarty 120803FPRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00690103205091), received between Aug 30, 2022 and Jan 31, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (2 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Oct 6, 2022Open, Classified

   Due to an increase of confirmed latex deterioration complaints for arterial embolectomy catheters packaged in pouches.

   Z-0146-2023 · Root cause: Packaging · FDA record ↗

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 31, 2025Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, DURING PROCEDURE WITH THIS FOGARTY EMBOLECTOMY CATHETER, RIGHT AFTER INFLATING THE BALLOON, IT BURST. AS PER PRODUCT EVALUATION FINDINGS, BALLOON WAS FOUND TO BE RUPTURED AT CENTRAL AREA AND THE SPRING TIP WIRE WAS EXPOSED. THERE IS NO ALLEGATION OF PATIENT INJURY. PATIENT DEMOGRAPHICS WERE NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21283017 ↗
• MalfunctionOct 27, 2022Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT A TEAM OF EW REPRESENTATIVES PERFORMED AN ON-SITE VISIT TO INVESTIGATE COMPLAINTS RELATED TO FOGARTY CATHETERS IN THE VASCUPOUCH. THE INITIAL INTERVIEW WITH HOSPITAL STAFF STATED THAT CATHETERS WERE STORED EITHER IN CENTRAL SUPPLY OR THE OR CORE. THE EDWARDS TEAM VISITED THE LOCATIONS WITHIN THE HOSPITAL WHERE CATHETERS WERE RECEIVED, STORED, AND ULTIMATELY USED. DURING THE FACILITY WALK THROUGH, IT WAS FOUND THAT THE CATHETERS WERE ALSO STORED IN TRAUMA OR 1. CATHETERS WERE TESTED IN LOCATIONS WHERE BOTH THE OUTER CORRUGATED PACKAGING HAD BEEN REMOVED AND PRIOR TO THE LOCATION OF THE REPORTED FAILURE, SPECIFICALLY, OR CORE AND TRAUMA OR 1. THE TEAM FOUND EVIDENCE OF XRAY IMAGING AND UV SANITIZATION BEING PRESENT IN TRAUMA OR 1, WHICH CORRESPONDS WITH OTHER FACILITY VISIT FINDINGS OF HIGH ENERGY SOURCES WHERE THE CATHETERS ARE STORED. THIS REPORT IS FOR ONE OF THE MODEL 120803FP, LOT 63883786 CATHETERS FROM TRAUMA OR 1 WHICH WAS NOTED TO HAVE A BALLOON THAT WOULD NOT INFLATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15680157 ↗
• MalfunctionAug 30, 2022Material Fragmentation; Material Rupture; Material Fragmentation; Material Rupture

  IT WAS REPORTED THAT PRIOR TO USE, THE BALLOONS ON SEVEN ARTERIAL EMBOLECTOMY CATHETERS WERE NOTED TO HAVE HOLES IN THEM WHEN INFLATED. IT WAS STATED THAT THE SURGEON WAS CONCERNED AND HAS A BUNCH OF EXPERIENCE WITH THESE CATHETERS, SO THE CUSTOMER FELT THAT IT WAS NOT USER ERROR. THE ONLY TROUBLESHOOTING WAS TO GET ANOTHER CATHETER HOWEVER, THE TECH STATED THAT AS SHE INFLATED THE BALLOON WITH FLUID THERE WERE MULTIPLE PIN HOLES IN THE BALLOON. THERE WAS NO PATIENT INJURY. THE EXACT DATE OF THE EVENT IS UNKNOWN. THIS REPORT IS FOR ONE MODEL 120803FP CATHETER FROM LOT 63954397.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15321025 ↗