Walrus FG 00100-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00857545008028), received between Mar 7, 2024 and Jun 24, 2024 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (4 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 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJun 24, 2024Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  ON 5/28/2024, Q'APEL MEDICAL RECEIVED AN EMAIL FROM THE FDA NOTIFYING THE COMPANY OF A VOLUNTARY MDR THAT WAS SUBMITTED ON 5/5/2024. PER THE REPORTED PROBLEM STATEMENT: "CERVICAL LEFT INTERNAL CAROTID ARTERY DISSECTION AT SITE OF WALRUS BALLOON GUIDE CATHETER INFLATION WITH CONTRAST POOLING IN FALSE LUMEN, CREATING FUSIFORM DILATION AND REQUIRING ANTIPLATELET USE (ASPIRIN) TO PREVENT THROMBOEMBOLISM. THIS OCCURRED AFTER MECHANICAL THROMBECTOMY FOR INTRACRANIAL LARGE-VESSEL OCCLUSION (LEFT MIDDLE CEREBRAL ARTERY OCCLUSION). 95-CM 8F WALRUS BGC." THE LOCATION PROVIDED WAS THE USA. NO OTHER INFORMATION WAS PROVIDED IN THE REPORT.

  Patient problems: Vascular Dissection

  MAUDE report 19602376 ↗
• InjuryMay 1, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  RETROACTIVE REPORTING TO THE FDA OF AN INCIDENT THAT OCCURED IN THE EU MARKET (GERMANY) ON 06/25/2023. Q'APEL MEDICAL BECAME AWARE OF THE INCIDENT ON 10-26-2023. Q'APEL MEDICAL FILED AN MIR REPORT ON 11/10/2023. REASON FOR COMPLAINT: DISSECTION AFTER USING WALRUS. IN AN EMAIL FROM (B)(6) DATED 10/31/2023, 3 CASES FROM THE SAME HOSPITAL AND ATTENDING PHYSICIAN WERE REPORTED TO Q'APEL QUALITY. (B)(6) WILL REPORT FINDINGS FOR CASE 3 AS DOCUMENTED IN EMAILS AND PHYSICIAN'S REPORTING NOTES. "DISSECTION AFTER USING WALRUS" THROMBECTOMY OF M2 SEGMENT TYPE OF INJURY AND LOCATION: DISSECTION IN 2 PARTS OF ICA ( PETROUS AND CAVERNOUS). M2 CLOSURE ON THE RIGHT. PLACEMENT IN THE CAVERNOUS SEGMENT. AFTER THROMBECTOMY KL. DISSECTION UNDER THE ENTRANCE TO THE ROCK BONE AND IN THE HORIZONTAL SECTION OF THE PARS PETROSA. AFTER 1 D CLOSURE OF THE ACI: 2 DISSECTIONS, ONE AT THE ENTRANCE TO THE PELVIC LEG, A SECOND CAVERNOUS WHERE THE BALLOON WAS INFLATED. RECANALIZATION WITH 2 STENTS.

  Patient problems: Vascular Dissection

  MAUDE report 19226933 ↗
• MalfunctionMay 1, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  RETROACTIVE REPORTING TO THE FDA OF AN INCIDENT THAT OCCURED IN THE EU MARKET (GERMANY) ON 07/08/2023 . Q'APEL MEDICAL BECAME AWARE OF THE INCIDENT ON 10-26-2023. Q'APEL MEDICAL FILED AN MIR REPORT ON 11/10/2023. REASON FOR COMPLAINT: DISSECTION AFTER USING WALRUS. IN AN EMAIL FROM (B)(6) (CMO) AND (B)(6) DATED 10/31/2023, 3 CASES FROM THE SAME HOSPITAL AND ATTENDING PHYSICIAN WERE REPORTED TO Q'APEL QUALITY. CASE 2 PRELIMINARY INFORMATION WAS COMMUNICATED TO Q'APEL QUALITY ON 10/31/2023. UNCLEAR, AT THE TIME OF THE COMPLAINT OPEN DATE, IF THE PATIENT REQUIRED MEDICAL INTERVENTION. "DISSECTION AFTER USING WALRUS". M2 CLOSURE ON THE RIGHT. WHEN THE WALRUS ADVANCES TO THE ENTRANCE OF THE PELVIC BONE, ASYSTOLE, AFTER WITHDRAWAL SPONTANEOUS RHYTHM AGAIN, BUT PERSISTENT ATRIAL FIBRILLATION. ESPECIALLY SMALL DISSECTION IN THE PROXIMAL CERVICAL ACI WITHOUT HEMODYNAMIC RELEVANCE. (B)(4) WILL REPORT FINDINGS FOR CASE 2 AS DOCUMENTED IN EMAILS AND PHYSICIAN'S REPORTING NOTES.

  Patient problems: Vascular Dissection

  MAUDE report 19226670 ↗
• MalfunctionMay 1, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  RETROACTIVE REPORTING TO THE FDA OF AN INCIDENT THAT OCCURED IN THE EU MARKET (GERMANY) ON (B)(6) 2023. Q'APEL MEDICAL BECAME AWARE OF THE INCIDENT ON (B)(6) 2023. Q'APEL MEDICAL FILED AN MIR REPORT ON 11/10/2023. REASON FOR COMPLAINT: DISSECTION AFTER USING WALRUS IN AN EMAIL FROM (B)(6) DATED 10/31/2023: "DISSECTION AFTER USING WALRUS" "M2 CLOSURE ON THE LEFT. S-SHAPED ELONGATION OF PROXIMAL ACI, INSURMOUNTABLE WITH WALRUS, AFTER EXTRACTION V.A. DISSECTION (NOT HEMODYN. EFFECTIVE). INFORMATION WAS COMMUNICATED TO Q'APEL QUALITY ON 10/31/2023. UNCLEAR, AT THE TIME OF COMPLAINT OPEN DATE, IF THE PATIENT REQUIRED MEDICAL INTERVENTION. Q'APEL PERSONNEL HAVE MADE THREE ATTEMPTS TO REQUEST FOR DETAILED INFORMATION REGARDING THE INCIDENT. DATA REGARDING THE INCIDENT WILL NOT BE COLLECTED BY THE DOCTOR ACCORDING TO THE EMAIL FROM THE Q'APEL SALES REPRESENTATIVE DATED ON 11/02/2023. CONCLUSION: UNABLE TO DETERMINE ROOT CAUSE. THE INFORMATION PROVIDED TO Q'APEL DOES NOT STATE THAT A PRODUCT MALFUNCTION OCCURRED. AN ADVERSE EVENT APPEARS TO HAVE OCCURRED BUT THERE IS NOT ENOUGH INFORMATION AVAILABLE TO CLASSIFY THE DEVICE PROBLEM. FG 00100-01, LOT FG220817J-02 WAS NOT RETURNED TO Q'APEL.

  Patient problems: Vascular Dissection

  MAUDE report 19224693 ↗
• MalfunctionMar 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RETROACTIVE REPORTING TO THE FDA OF AN INCIDENT THAT OCCURED IN THE UK MARKET ON 4/21/2023. Q'APEL MEDICAL BECAME AWARE OF THE INCIDENT ON 5/9/2024. Q'APEL MEDICAL FILED AN INITIAL MIR REPORT ON 5/18/2023. Q'APEL MEDICAL FILED A FINAL MIR REPORT ON 6/8/2023. CONCLUSION: AN ADVERSE EVENT (E.G. PATIENT HARM) APPEARS TO HAVE OCCURRED, BUT THERE DOES NOT APPEAR TO HAVE BEEN A PROBLEM WITH THE DEVICE OR THE WAY IT WAS USED. THE DEVICE DID NOT MALFUNCTION. PHYSICIAN HAD ASSESSED THAT THIS PATIENT WOULD BE VERY PRONE TO VESSEL SPASM. PHYSICIAN BELIEVES THERE WAS SOME SPASM DURING DELIVERY WHICH CAUSED A SMALL DISSECTION. IMAGING SHOWS THAT THE BALLOON NEVER PASSED THE SITE OF DISSECTION, SO IT WAS LIKELY GUIDE WIRE RELATED. AS A REMEDIAL ACTION, THE PHYSICIAN HAD ADMINISTERED 500MG OF ASPIRIN INTRAVENOUSLY AND WAITED 20 MINUTES BEFORE BEING SATISFIED THAT THE ISSUE HAD RESOLVED. THE DISSECTION WAS NOT VISIBLE ON THE CTA THE NEXT DAY. ADDITIONAL INFORMATION ABOUT THE PATIENT: AGE OF PATIENT - 40; GENDER - MALE; ONSET - 17:45; 1ST RUN - 22:05; LOCATION OF CLOT - LEFT M1/M2; NIHSS - 8/21. SHEATH - 9F CORDIS AVANTI+ INTERMEDIATE - RED 62. STENTRIEVER - SOLITAIATE 4X40. TICI SCORE - 3. PATIENT

  Patient problems: Vascular Dissection

  MAUDE report 18862161 ↗