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PROWLER
Medos International Sàrl · Model 606-051X · UDI-DI 10886704028550
KRA
Prescription
3
510(k) clearances
9,137
Adverse events (366 deaths)
137
Recalls
150
Facilities
Description
PROWLER 10 Infusion Catheter with 2 Markers Infusion Catheter 2.3F (0.75 mm) 1.7F (0.55 mm) .015 Inch (0.4 mm) 3cm 50 cm 150 cm Contents: 1 Infusion Catheter and 1 Shape Mandrel. Minimum Guiding Catheter I.D. / Dia. .035 Inch (0.9 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.