CLASS II ONGOING Device recall · Reported 29 Jul 2026 · FDA Enforcement Report

Pipeline Flex Embolization Device with Shield Technology recalled

Micro Therapeutics is recalling Pipeline Flex Embolization Device with Shield Technology 027, distributed nationwide in the US. The recall was initiated on 8 Jun 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI: 00763000448806/ Lot: D062612

Quantity recalled11 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2773-2026
FDA event ID: 99326
Recalling firm: Micro Therapeutics, Irvine, CA
Classification: Class II
Status: Ongoing
Recall initiated: 8 Jun 2026
FDA classified: 22 Jul 2026
Reported: 29 Jul 2026
Type: Voluntary: Firm initiated
Customers notified by: Visit
Reason category: Labeling Errors
Device type: Other Medical Devices

Timeline

8 Jun 2026	Recall initiated by company
22 Jul 2026	Classified by FDA	+44 days
29 Jul 2026	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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.

Product as listed by the FDA

Pipeline Flex Embolization Device with Shield Technology, 3.00 mm x 12 mm 027 REF PED2-300-12. Intracranial aneurysm flow diverter

Where it was distributed

US Nationwide distribution in the states of CT, DE, IN, MA, NC, NJ, NM, NY, OH, PA, TX, VA, WA.

Nationwide Connecticut Delaware Indiana Massachusetts North Carolina New Jersey New Mexico New York Ohio Pennsylvania Texas Virginia Washington

Questions about this recall

Why was it recalled?

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.

Which lots are affected?

UDI: 00763000448806/ Lot: D062612

Where was it sold?

US Nationwide distribution in the states of CT, DE, IN, MA, NC, NJ, NM, NY, OH, PA, TX, VA, WA.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 99326

This product is part of a recall event; the main page for the event is Pipeline Flex Embolization Device with Shield Technology recalled.

Reported	Class	Recall	Company	Reason	Where
29 Jul 2026	CLASS II	Pipeline Flex Embolization Device with Shield Technology recalled	Micro Therapeutics	Labeling Errors	Nationwide

More recalls from Micro Therapeutics

All 9

Reported	Class	Recall	Company	Reason	Where
29 Jul 2026Device	CLASS II	Pipeline Flex Embolization Device with Shield Technology recalled	Micro Therapeutics	Labeling Errors	Nationwide
12 Mar 2025Device	CLASS I	Medtronic Pipeline Vantage Embolization Device recalled	Micro Therapeutics	Other	Nationwide
12 Mar 2025Device	CLASS I	Medtronic Pipeline Vantage Embolization Device recalled	Micro Therapeutics	Other	Nationwide
13 Mar 2024Device	CLASS II	The Apollo Onyx Delivery Microcatheter recalled by Micro Therapeutics	Micro Therapeutics	Other	Nationwide
13 Mar 2024Device	CLASS II	The Apollo Onyx Delivery Microcatheter recalled by Micro Therapeutics	Micro Therapeutics	Other	Nationwide

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30 Sep 2026Device	CLASS II	Medline Convenience Kits: Mfc Craniotomy Pack recalled	Medline Industries	Other	Nationwide