FDA recall, , Moderate risk
Pipeline Flex Embolization Device with Shield Technology
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.
Summary by Recall Canary from the FDA notice
What happened
Micro Therapeutics, Inc., of Irvine, California, began a recall on June 8, 2026, of Pipeline Flex Embolization Device with Shield Technology products due to incorrect labeling: 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.
The FDA added the recall to its Enforcement Report on July 22, 2026, and included it in the weekly enforcement report on July 29, 2026. Distribution was nationwide in the states of CT, DE, IN, MA, NC, NJ, NM, NY, OH, PA, TX, VA, and WA.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
2 products
Affected if its UDI-DI is listed.
A UDI-DI is the device identifier printed with the barcode on the device label.
Pipeline Flex Embolization Device with Shield Technology, 3.00 mm x 20 mm 027 REF PED2-300-20
- UDI-DI
- 00763000448844
Pipeline Flex Embolization Device with Shield Technology, 3.00 mm x 12 mm 027 REF PED2-300-12
- UDI-DI
- 00763000448806
Recall details
- Company began the recall
- Sold in
US Nationwide distribution in the states of Connecticut, Delaware, Indiana, Massachusetts, North Carolina, New Jersey, New Mexico, New York, Ohio, Pennsylvania, Texas, Virginia, Washington.
- Company
- Micro Therapeutics, Inc.Irvine, California
- Hazard
- Labeling error
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99326
- Recall numbers
- Z-2773-2026 to Z-2774-2026
All recalls from Micro Therapeutics, Inc.
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
