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Stellarex
Spectranetics Corporation · Model AB35SX040100080 · UDI-DI 00813132024970
ONU
Prescription
0
510(k) clearances
5,888
Adverse events (528 deaths)
1
Recalls
26
Facilities
Description
Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (4mm x 100mm) x 80cm
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-03-23 | Medtronic Vascular, Inc. | Packaging for Balloon Catheters may be damaged resulting in loss of sterility. |
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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.