medical MODERATE Updated 2026-07-29

Micro Therapeutics, Inc. recalls Pipeline Flex Embolization Device with Shield Technology, 3.

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Recalled Product

Pipeline Flex Embolization Device with Shield Technology, 3.00 mm x 12 mm 027 REF PED2-300-12

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Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: UDI: 00763000448806/ Lot: D062612, D112860

✅ What Should You Do?

  1. 1Contact your healthcare provider immediately to discuss this recall.
  2. 2Stop using the device if it is safe to do so, and contact your provider.
  3. 3Follow the manufacturer's remedy instructions provided in the recall notice.
  4. 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.
View official government recall