Home › Spectranetics Corporation › AngioSculpt®PTCA Scoring Balloon Catheter
AngioSculpt®PTCA Scoring Balloon Catheter
Spectranetics Corporation · Model 2001-3010 · UDI-DI 00813132022136
NWX
Prescription
0
510(k) clearances
7,792
Adverse events (51 deaths)
3
Recalls
12
Facilities
Description
AngioSculpt® PTCA Scoring Balloon Catheter
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 |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
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.