Wahoo FG 00074Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00857545008004), received between May 2, 2025 and May 2, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Obstruction of Flow” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 2, 2025Obstruction of Flow; Obstruction of Flow

  DURING A RETROSPECTIVE LEGACY COMPLAINT FILE REVIEW FOR POTENTIAL MDR REPORTABLE EVENTS, (B)(4) (EVENT DATE-01/13/2021), WAS OBSERVED TO HAVE MET THE REPORTABILITY CRITERIA AFTER THE INVESTIGATION OF THE RETURNED PRODUCT WAS COMPLETED ((B)(6) 2021). NOTE: ON (B)(6) 2023, Q'APEL MEDICAL INC. DECIDED TO CEASE THE PRODUCTION OF WAHOO SELECTFLEX 072 NEUROVASCULAR ACCESS SYSTEM. TIMELINE OF EVENTS: -(B)(4) INITIAL MDR EVALUATION: AT THE TIME OF THE COMPLAINT, Q'APEL MEDICAL DETERMINED THE EVENT WAS NOT REPORTABLE UNDER 21 CFR 803.50 BASED ON AVAILABLE INFORMATION. SPECIFICALLY, THE EVALUATION CONCLUDED THE DEVICE DID NOT: 1. CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY; OR 2. MALFUNCTION IN A WAY THAT, IF IT WERE TO RECUR, WOULD LIKELY RESULT IN A DEATH OR SERIOUS INJURY. -CASE OVERVIEW (PROVIDED BY SALES REPRESENTATIVE): 1. WAHOO CATHETER WAS TRACKED TO THE TARGET ANATOMY AND USED TO DEPLOY A SURPASS FLOW DIVERTER. 2. UPON ATTEMPT TO PASS A WIRE POST-DEPLOYMENT, RESISTANCE WAS NOTED. 3. RESISTANCE DURING WITHDRAWAL PROMPTED SIMULTANEOUS REMOVAL OF THE WAHOO AND 8F SHEATH. 4. INITIAL INSPECTION SUGGESTED THE CATHETER WAS INTACT. 5. THE PATIENT HAD HIGHLY TORTUOUS VASCULATURE. NO HAR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21952073 ↗