Paclitaxel-Coated Balloons (PCB) and Paclitaxel-Eluting Stents (PES) for the Treatment of Peripheral Arterial Disease (PAD) and the Potential Risk of Long-Term All-Cause Mortality
CanadaPaclitaxel-Coated Balloons (PCB) and Paclitaxel-Eluting Stents (PES) for the Treatment of Peripheral Arterial Disease (PAD) and the Potential Risk of Long-Term All-Cause Mortality
Recalling Firm: Marketed health products
Motif du rappel / Danger
TranslatedProduct safety
Description du produit & Identification
TranslatedPaclitaxel-Coated Balloons (PCB) and Paclitaxel-Eluting Stents (PES) for the Treatment of Peripheral Arterial Disease (PAD) and the Potential Risk of Long-Term All-Cause Mortality
Produits concernés
TranslatedPaclitaxel-Coated Balloons (PCB) and Paclitaxel-Eluting Stents (PES)
Additional Source Details
| Field | Value |
|---|---|
| N I D | 59479 |
| U R L | https://recalls-rappels.canada.ca/en/alert-recall/paclitaxel-coated-balloons-pcb-and-paclitaxel-eluting-stents-pes-treatment-peripheral |
| Issue | Product safety |
| Title | Paclitaxel-Coated Balloons (PCB) and Paclitaxel-Eluting Stents (PES) for the Treatment of Peripheral Arterial Disease (PAD) and the Potential Risk of Long-Term All-Cause Mortality |
| Product | Paclitaxel-Coated Balloons (PCB) and Paclitaxel-Eluting Stents (PES) |
| Archived | 0 |
| Category | Medical devices |
| Last updated | 2024-02-20 |
| Organization | Marketed health products |
Consumer Action Protocol: What You Should Do Immediately
Safety StepsCheck the model number, serial number, and date stamp on the rating label on the back or underside of the product.
Immediately discontinue using the product. Unplug electrical items and keep juvenile items out of reach of children.
Under statutory consumer protection rules, consumers are entitled to a full refund, certified replacement, or free repair kit without needing the original sales receipt.
If you suffered an injury, illness, or property damage from this product, file an official incident report with regulatory authorities (Health Canada).
Your Legal Rights as a Consumer
Recalls are legally binding corrective safety actions overseen by statutory government bodies. Recalling entities are legally prohibited from charging consumers for official safety remedies. If a retailer or dealership refuses your recall remedy, notify the issuing regulatory agency immediately.
Frequently Asked Questions About This Recall
FAQ GuideQ1:What should I do immediately if I own or bought Paclitaxel-Coated Balloons (PCB) and Paclitaxel-Eluting Stents (PES) for the Treatment of Peripheral Arterial Disease...?
Immediately stop using the product and keep it out of reach of children. Disconnect power if electrical, and do not attempt makeshift home repairs.
Q2:Can I get a full refund or free repair for this recall?
Yes. Recalling manufacturers and retail merchants are required under consumer protection regulations to offer a statutory remedy—typically a full refund, certified repair kit, or replacement unit.
Q3:Do I need my original sales receipt to claim a remedy or refund?
In most recall cases, no receipt is required. Because safety recalls are matters of public health and statutory compliance, retailers and manufacturers routinely issue refunds, store credit, or replacement kits upon presentation of the affected product or lot code.
Q4:Where can I verify official information for this safety alert?
This safety alert is aggregated directly from official regulatory agency records (Health Canada). You can click the 'Official Agency Alert' link on this page to view the primary government notice and contact the manufacturer directly.
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🚨 SAFETY ALERT: Marketed health products - Paclitaxel-Coated Balloons (PCB) and Paclitaxel-Eluting Stents (PES) for the Treatment of Peripheral Arterial Disease (PAD) and the Potential Risk of Long-Term All-Cause Mortality Check if your household is affected: https://therecallfile.com/fr/recalls/paclitaxel-coated-balloons-pcb-and-paclitaxel-eluting-stents-pes-for-t/CANADA-59479
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