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Visi-Pro™
Covidien LP · Model PXB35-06-57-135 · UDI-DI 00643169787735
0
510(k) clearances
33,655
Adverse events (359 deaths)
450
Recalls
148
Facilities
Description
PXB35-06-57-135 STENT VISI PRO 035 V01
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-05-22 | W L Gore & Associates, Inc. | 10 mm diameter x 7 cm with transmural drainage holes (VSWVH1006) incorrectly labeled as 10 mm diameter x 10 cm length devices without transmural drainage holes (VSWVN1010). |
| 2026-05-22 | W L Gore & Associates, Inc. | 10 mm diameter x 7 cm with transmural drainage holes (VSWVH1006) incorrectly labeled as 10 mm diameter x 10 cm length devices without transmural drainage holes (VSWVN1010). |
| 2026-05-21 | Boston Scientific Corporation | Potential sterile breach of the pouches in which devices are packaged. |
| 2026-05-21 | Boston Scientific Corporation | Potential sterile breach of the pouches in which devices are packaged. |
| 2026-05-21 | Boston Scientific Corporation | Potential sterile breach of the pouches in which devices are packaged. |
| 2026-05-21 | Boston Scientific Corporation | Potential sterile breach of the pouches in which devices are packaged. |
| 2026-05-21 | Boston Scientific Corporation | Potential sterile breach of the pouches in which devices are packaged. |
| 2026-05-21 | Boston Scientific Corporation | Potential sterile breach of the pouches in which devices are packaged. |
| 2026-03-05 | Cook Incorporated | Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. |
| 2025-08-28 | Boston Scientific Corporation | The product in incorrectly labeled. The label indicates that the skive hole should be above the balloon, while it is actually positioned below, and vice versa. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.