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AngioSculpt OTW PTA Scoring Balloon Catheter with HydroCross Coating
The Spectranetics Corporation · Model 2290-50100 · UDI-DI 00813132022945
PNO
Prescription
10
510(k) clearances
2,118
Adverse events (2 deaths)
3
Recalls
34
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2019-05-24 | Cook Inc. | Multiple complaints were received for balloons bursting below the rated burst pressure. Potential adverse events that may occur if an affected product is used include a delay in t |
| 2019-05-24 | Cook Inc. | Multiple complaints were received for balloons bursting below the rated burst pressure. Potential adverse events that may occur if an affected product is used include a delay in t |
| 2019-05-24 | Cook Inc. | Multiple complaints were received for balloons bursting below the rated burst pressure. Potential adverse events that may occur if an affected product is used include a delay in t |
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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.