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Open, Classified

Medtronic Pipeline Vantage Embolization Device with Shield Technology, REF: PED3-027-350-12, PED3-027-350-14, PED3-027-350-16, PED3-027-350-20, PED3-027-350-25, PED3-027-400-12, PED3-027-400-14, PED3-027-400-16, PED3-027-400-18, PED3-027-400-20, PED3-027-400-25, PED3-027-400-30, PED3-027-450-12, PED3-027-450-14, PED3-027-450-16, PED3-027-450-18, PED3-027-450-20, PED3-027-450-25, PED3-027-450-30, PED3-027-450-40, PED3-027-500-14, PED3-027-500-16, PED3-027-500-18, PED3-027-500-20, PED3-027-500-25, PED3-027-500-30, PED3-027-500-40, PED3-027-550-16, PED3-027-550-18, PED3-027-550-20, PED3-027-550-30, PED3-027-550-40, PED3-027-550-50, PED3-027-600-16, PED3-027-600-18, PED3-027-600-20, PED3-027-600-30, PED3-027-600-40, PED3-027-600-50

FDA Recall Z-1245-2025 · Posted 2025-03-05

Recalling FirmMicro Therapeutics, Inc.
Recall StatusOpen, Classified
Product CodeOUT
Date Initiated2025-01-30
Product Quantity18,245

Reason for Recall

Use of embolization device with diameters greater-than-or-equal-to 4mm may lead to incomplete wall apposition and/or braid deformation (fish-mouthing/braid narrowing/braid collapse) noted during procedure and post-procedure, typically noted at 6-12 month imaging follow-up, potentially can lead to thrombosis and/or serious adverse events. Higher risk in females less-than-or-equal-to 45 years of age

Firm Action

On 1/30/2025, Medtronic Neurovascular mailed "Urgent Safety and Labeling Notification" recall notices to healthcare professions who were asked to do the following: Removal (retrieval) is isolated to unused inventory of the Pipeline Vantage 027 devices: 1) Remove and quarantine all unused impacted products in your inventory. 2) Return the impacted products to firm. Firm representative can assist with identifying suitable replacement product. Correction of Instructions for Use applies to Pipeline Vantage 021 devices: The key updates are: 1) Appropriate device diameter and length selection to account for complex anatomy. 2) Techniques to deploy Pipeline Vantage compared to Pipeline Shield using a balance of device tension and compression to achieve adequate wall apposition and landing around curves. 2) Warnings about the consequences of incomplete wall apposition and suboptimal deployment and the increased risk of braid deformation in females, especially in females less-than-or-equal-to 45 years of age. Updated IFU M067713CDOC2 Rev. A (01/2025) was sent with the notice and can be found at: https://manuals.medtronic.com/manuals/ Share this communication within your organization, with other organizations where impacted devices have been transferred, and any other associated organizations that may be impacted by this action. Please maintain a copy of this letter for your records and the records of your patients. Complete and return the customer confirmation form via email to [email protected] Questions can be directed to the firm at [email protected] or call at 1(800) 633-8766 (US Toll free) or (763) 514-4000 (Worldwide), available 24 hours a day, 7 days a week.

Root Cause

Device Design

Distribution Pattern

Worldwide distribution: US (nationwide): PR, OK, CA, MD, FL, NY, WA, MI, AL, NV, MN, NJ, IL, OH, AK, CT, TN, MO, TX, ID, AZ, WI, PA, OR, SD, VA, CO, GA, KY, IN, AR, MA, LA, NE, MT, ME, SC, DC, NC, ND, NM, IA, UT, KS, WV, NH, HI, RI. And OUS (foreign) countries of: Algeria, Argentina, Armenia, Australia, Austria, Bahrain, Bangladesh, Belgium, Brazil, Bulgaria, Canada, Canary Islands, Chile, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Jordan, Kazakhstan, Kuwait, Latvia, Lebanon, Lithuania, Luxembourg, Malaysia, Martinique, Mexico, Republic Of Moldova, Montenegro, Morocco, Netherlands, New Zealand, North Macedonia, Northern Ireland, Norway, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Vietnam

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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