Medtronic Pipeline Vantage Embolization Device Recall for Structural Deformation Risk
Medtronic is recalling approximately 18,245 unused Pipeline Vantage embolization devices due to incomplete wall apposition and braid deformation that may lead to thrombosis and serious adverse events.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I classification applies per agency determination. The device defect can lead to thrombosis and serious adverse events, meeting the Severe threshold, despite no reported injuries to date.
Plain-English summary
Medtronic is recalling Medtronic Pipeline Vantage Embolization Devices with Shield Technology in various sizes. Approximately 18,245 unused units are affected, distributed worldwide including across U.S. states, territories, and numerous countries internationally. Affected devices are from product lots B317266 through B817292.
The recall addresses a defect in devices with diameters of 4 millimeters or larger. This defect can result in incomplete wall apposition and/or braid deformation—including fish-mouthing, braid narrowing, or braid collapse. These structural issues may be observed during the procedure, immediately after, or during follow-up imaging typically performed 6–12 months post-procedure.
Incomplete wall apposition and braid deformation can potentially lead to thrombosis (blood clot formation) and serious adverse events. Females aged 45 years or younger face higher risk from this defect. As of this recall notice, no injuries or illnesses have been reported in connection with this device defect.
The recalled product
- Product
- Medtronic Pipeline Vantage Embolization Device with Shield Technology, REF: PED3-027-350-12, PED3-027-350-14, PED3-027-350-16, PED3-027-350-20, PED3-027-350-25, PED3-027-400-12, PED3-027-400-14, PED3-027-400-16, PED3-027-400-18, PED3-027-400-20, PED3-027-400-25, PED3-027-400-30…
- Manufacturer
- Micro Therapeutics, Inc.
- Affected units
- 18,245
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 00847536030770/B409106
- B637287
- B700548
- PED3-027-350-14/00847536035287
- 00847536030787/B409234
- B700550
- B794880
- PED3-027-350-16/00847536035294
- 00847536030794/B409692
- B697962
- B700551
- B795136
- B795142
- B809808
- PED3-027-350-20/00847536035317
- 00847536030817/B410645
- B558444
- B623124
- B672921
- B700552
Distribution
Part of a larger recall action
This product is one of 2 recalled by Micro Therapeutics, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · Micro Therapeutics, Inc.
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- SevereMedtronic Pipeline Vantage device recall: deformation may cause blood clots
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