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Wolverine Coronary Cutting Balloon
BOSTON SCIENTIFIC CORPORATION · Model H74939402103750 · UDI-DI 08714729888024
NWX
Prescription
0
510(k) clearances
7,737
Adverse events (50 deaths)
3
Recalls
12
Facilities
Description
Microsurgical Dilatation Device
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2018-12-07 | Spectranetics Corporation | The incorrect outer carton box was used for the product. |
| 2009-12-04 | AngioScore Inc. | Separations of the PTCA catheter shaft at the guide wire exit port have occurred during treatment of coronary artery stenosis. Fragments of the catheter may become lodged in corona |
| 2007-11-13 | AngioScore Inc. | Mis-labeling: Product labeling on product pouch indicates wrong size, the correct size is on the product carton |
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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.