Home › Micro Therapeutics, Inc. › PhenomTM 21 Catheter
PhenomTM 21 Catheter
Micro Therapeutics, Inc. · Model FG13150-0615-2X · UDI-DI 00847536041820
1
510(k) clearances
9,137
Adverse events (366 deaths)
137
Recalls
150
Facilities
Description
CATHETER FG13150-0615-2X V04
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 |
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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.