Safety Alerts

Health Canada has posted a medical device safety alert concerning multiple Paclitaxel-Coated Balloons and Paclitaxel-Eluting Stents [HKMD number: 100030, 120368, 150212, 200444, 220093, 220387, 230015].

Device Affected:

1. Lutonix Inc.LUTONIX 035 DRUG COATED BALLOON PTA CATHETER
2. Medtronic Inc. IN.PACT ADMIRAL PACLITAXEL-COATED PTA BALLOON CATHETER
3. Lutonix Inc. LUTONIX 014 DRUG COATED PTA DILATATION CATHETER
4. Hemoteq AG RANGER OTW PACLITAXEL-COATED PTA BALLOON CATHETER
5. Hemoteq AG RANGER SL OTW PACLITAXEL-COATED PTA BALLOON CATHETER
6. Life Vascular Devices Biotech S.L. IVASCULAR LUMINOR 14M, PACLITAXEL ELUTING PTA BALLOON DILATATION CATHETER
7. Cook Ireland LTD. ZILVER PTX DRUG-ELUTING PERIPHERAL STENT (6FR)
8. Cook, Inc. ZILVER PTX DRUG-ELUTING PERIPHERAL STENT (7FR)
9. Biotronik AG PANTERA LUX PACLITAXEL RELEASING PTCA BALLOON CATHETER
10. Urotronic Inc. OPTILUME URETHRAL DRUG COATED BALLOON CATHETER

According to the Health Canada (HC), HC worked with manufacturers, clinicians, and other international health regulatory agencies to further assess the risk of increased mortality associated with the use of paclitaxel-coated devices used to treat peripheral arterial disease. Based on all available clinical evidence, Health Canada did not identify an increased risk of mortality associated with the use of these devices when used in accordance with the licensed indications. Healthcare professionals are advised to use the paclitaxel-coated devices in accordance with the licensed indications outlined in the labeling material.

For further information, please visit https://recalls-rappels.canada.ca/en/alert-recall/paclitaxel-coated-balloons-pcb-and-paclitaxel-eluting-stents-pes-treatment-peripheral

If you are in possession of the affected products, please contact your supplier for necessary actions.

Posted on 21 Feb 2024