Home › ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD. › CRITIFLO(TM) TA1018 (30ML/HR)
CRITIFLO(TM) TA1018 (30ML/HR)
ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD. · Model 682065 · UDI-DI 00886333620654
KRA
Prescription
10
510(k) clearances
9,137
Adverse events (366 deaths)
137
Recalls
150
Facilities
Description
30 cc Critiflo device
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.