Pipeline Flex Embolization Device with Shield Technology recall (Micro Therapeutics, Inc.)
Medical deviceClass IIOngoing
Summary: Micro Therapeutics, Inc. is recalling Pipeline Flex Embolization Device with Shield Technology, 3.00 mm x 12 mm 027 REF PED2-300-12. Intracranial aneurysm flow diverter. 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.
What is being recalled
Pipeline Flex Embolization Device with Shield Technology, 3.00 mm x 12 mm 027 REF PED2-300-12. Intracranial aneurysm flow diverter
Why
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.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
US Nationwide distribution in the states of CT, DE, IN, MA, NC, NJ, NM, NY, OH, PA, TX, VA, WA. (states named: Connecticut, Delaware, Indiana, Massachusetts, North Carolina, New Jersey, New Mexico, New York, Ohio, Pennsylvania, Texas, Virginia, Washington)
How to tell if yours is affected
UDI: 00763000448806/ Lot: D062612
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-2773-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | June 8, 2026 |
| Reported | July 29, 2026 |
| Company | Micro Therapeutics, Inc. |
| Company location | Irvine, CA, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 11 units |
More recalls from Micro Therapeutics, Inc. · all medical device recalls · recalls from June 2026