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Millennium

Avalign Technologies, Inc. · Model 1-293216 · UDI-DI 00190776302016

EZB Prescription

510(k) clearances

2,447

Adverse events (24 deaths)

Recalls

Facilities

Description

Female Catheter 5 34" 16fr

Recalls

Date	Firm	Reason
2020-03-09	Boston Scientific	An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the affected device
2020-03-09	Boston Scientific	An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the affected device
2020-03-09	Boston Scientific	An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the affected device
2020-03-09	Boston Scientific	An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the affected device
2020-03-09	Boston Scientific	An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the affected device
2020-03-09	Boston Scientific	An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the affected device
2020-03-09	Boston Scientific	An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the affected device
2020-03-09	Boston Scientific	An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the affected device
2020-03-09	Boston Scientific	An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the affected device
2020-03-09	Boston Scientific	An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the affected device

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Data 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.