Walrus FG 00100-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00857545008011), received between Mar 8, 2024 and Mar 8, 2024 — classified as 1 injury.

The most frequently reported specific device problem is “Use of Device Problem” (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 16, 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.

• InjuryMar 8, 2024Use of Device Problem; Use of Device Problem

  RETROACTIVE REPORTING TO THE FDA OF AN INCIDENT THAT OCCURED IN THE UK MARKET ON 4/20/2023. Q'APEL MEDICAL BECAME AWARE OF THE INCIDENT ON 4/20/2023. Q'APEL MEDICAL FILED AN INITIAL MIR REPORT ON 4/26/23. Q'APEL MEDICAL FILED A FINAL MIR REPORT ON 5/24/23. CONCLUSION: THE DEVICE DID NOT MALFUNCTION. THE OPERATOR CONFIRMED HE OVER-INFLATED ACCORDING TO THE VESSEL SIZE AND DID NOT FOLLOW RECOMMENDATIONS OR THE MANUFACTURER'S INSTRUCTIONS. WALRUS USED WAS THE 90CM VERSION BG8087-090 LOT NO. FG220811J-03. PHYSICIAN NAME: DR (B)(6). HOSPITAL NAME: (B)(6) HOSPITAL. 75 YO MALE WITH A RIGHT M1 OCCLUSION SUFFERING AN ACUTE ISCHEMIC STROKE. PATIENT WAS TREATED UNDER GENERAL ANESTHESIA. OTHER DEVICES UTILIZED IN THE PROCEDURE WERE A SOFIA PLUS ASPIRATION CATHETER, PHENNOM 21 MICRO CATHETER AND A SOLITAIRE STENT. RETRIEVER THE WALRUS BGC WAS PLACED IN THE DISTAL CERVICAL SEGMENT OF THE R ICA PHYSICIAN INITIALLY INFLATED THE WALRUS WITH APPROX 0.3CC'S OF CONTRAST/SALINE MIX. THEY FELT THAT THE BALLOON WAS NOT STABLE SO CONTINUED TO INFLATE WITH MAXIMUM RECOMMENDED VOLUME OF 0.6CC'S. PHYSICIAN COMPLETED ONE PASS WITH THE SOLITAIRE STENT RETRIEVER AND THE SOFIA PLUS ASPIRATION CATHETER. ONCE THAT

  Patient problems: Vascular Dissection

  MAUDE report 18871670 ↗