Medtronic Pipeline Vantage device recall: deformation may cause blood clots
The Pipeline Vantage Embolization Device may malfunction, with the braid deforming or not positioning correctly, potentially causing blood clots. Approximately 7,820 units are affected worldwide.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I classification establishes a minimum severity of 4. The source describes device malfunction (incomplete wall apposition and braid deformation) that can lead to thrombosis and serious adverse events, but no actual illnesses or injuries have been reported.
Plain-English summary
The Medtronic Pipeline Vantage Embolization Device with Shield Technology is the subject of a Class I recall by manufacturer Micro Therapeutics, Inc., affecting approximately 7,820 units.
The device may fail to position correctly against the vessel wall (incomplete wall apposition) or may experience braid deformation, such as narrowing or collapse. These failures typically occur during or shortly after the procedure but are often detected during follow-up imaging performed 6 to 12 months post-procedure. The malfunction can potentially lead to blood clots and other serious adverse events.
The affected devices have been distributed worldwide to healthcare facilities in the United States, U.S. territories, and many countries internationally. Female patients 45 years of age and younger are identified as being at higher risk.
The recalled product
- Product
- Medtronic Pipeline Vantage Embolization Device with Shield Technology, REF: PED3-021-350-16, PED3-021-250-14, PED3-021-350-20, PED3-021-250-20, PED3-021-300-16, PED3-021-300-20, PED3-021-275-12, PED3-021-275-16, PED3-021-325-12, PED3-021-325-14, PED3-021-325-16, PED3-021-325-20,
- Manufacturer
- Micro Therapeutics, Inc.
- Hazard
- apposition-failure
- braid-deformation
- thrombosis-risk
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)
- Instructions for Use
- Version: Rev. A (01/2024). REF/UDI-DI/Lot: PED3-021-350-16/00847536030701
- 00847536035195
- 00847536036529/B317460
- B327449
- B335184
- B340948
- B349032
- B389162
- B392918
- B424454
- B430015
- B495821
- B497938
- B547396
- B550307
- B551615
- B559033
- B603377
- B623564
Distribution
Distributed nationwide across the United States.
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