Home › Angiodynamics, Inc. › PulseSpray
PulseSpray
Angiodynamics, Inc. · Model H787125004520 · UDI-DI 15051684013581
KRA
Prescription
1
510(k) clearances
9,137
Adverse events (366 deaths)
137
Recalls
150
Facilities
Description
PulseSpray Infusion System
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-09-16 | Boston Scientific Cork, Ltd. | The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridge |
| 2026-09-16 | Boston Scientific Cork, Ltd. | The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridge |
| 2026-09-16 | Boston Scientific Cork, Ltd. | The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridge |
| 2026-09-16 | Boston Scientific Cork, Ltd. | The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridge |
| 2026-09-16 | Boston Scientific Cork, Ltd. | The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridge |
| 2026-09-16 | Boston Scientific Cork, Ltd. | The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridge |
| 2026-09-16 | Boston Scientific Cork, Ltd. | The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridge |
| 2026-09-16 | Boston Scientific Cork, Ltd. | The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridge |
| 2026-09-16 | Boston Scientific Cork, Ltd. | The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridge |
| 2026-09-16 | Boston Scientific Cork, Ltd. | The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridge |
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.