Micro Therapeutics, Inc.: Intracranial Aneurysm Flow Diverter
Recall Summary Micro Therapeutics is recalling Pipeline Flex Embolization Devices (used to treat brain aneurysms) because the implants are labeled with incorrect sizes—devices marked as 3.0 mm x 20 mm actually contain 12 mm implants, and those marked as 3.0 mm x 12 mm actually contain 20 mm implants. The affected product (model PED2-300-20) was distributed nationwide to hospitals and medical facilities. This mislabeling could result in surgeons implanting the wrong-sized device during procedures.
- Recalling firm
- Micro Therapeutics, Inc.
- Product
- Pipeline Flex Embolization Device with Shield Technology, 3.00 mm x 20 mm 027 REF PED2-300-20
- Reason
- Incorrect labeling - embolization devices labeled as 3.0 mm x 20 mm implants contain 12 mm implants, and devices labeled as 3.0 mm x 12 mm implants contain 20 mm implants.
- Classification
- Class III
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-06-08
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- US Nationwide distribution in the states of CT, DE, IN, MA, NC, NJ, NM, NY, OH, PA, TX, VA, WA.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/ab88d131-0126-4985-82ec-3a6e5c196999