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PROWLER
Medos International Sàrl · Model 606-2310F · UDI-DI 10886704028659
KRA
Prescription
2
510(k) clearances
9,137
Adverse events (366 deaths)
137
Recalls
150
Facilities
Description
PROWLER PLUS Infusion Catheter 2.8F (0.95 mm) 2.3F (0.75 mm) .021 Inch (.5 mm) 20 cm 135 cm MP Contents: 1 Infusion Catheter and 1 Shape Mandrel. Minimum Guiding Catheter I.D. / Dia. .042 Inch (1.1 mm)
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.