Introduction: coordinating compliance and care in high-risk medical device recalls

With medical device recalls come unique challenges, especially when those devices are used in hospitals, health clinics, doctors’ offices, and in patients’ homes around the world.

With medical device recalls come unique challenges, particularly when those devices are relied upon in hospitals, clinics, physicians’ offices, and patients’ homes worldwide. The complexity of these recalls extends far beyond regulatory compliance—effective communication, reverse logistics, software updates, and customer support are critical to protecting patient health and wellbeing.

Défi

What began as a standard manufacturer-issued consumer notification regarding a potential device malfunction quickly escalated into a full-scale recall and discontinuation of a widely used blood monitoring system.

In-home medical devices are among the most complicated products to recall, as the abrupt removal of a product without careful transition and adequate replacement can pose significant risks to patient care. A global leader in point-of-care diagnostics encountered this dilemma when it initiated a voluntary recall of its in-home blood monitoring system, a device essential for patients managing blood-thinning medications.

Upon identifying potential malfunctions, the company promptly reported its findings to the U.S. Food and Drug Administration (FDA) and launched an extensive investigation. As part of its commitment to patient safety, it advised certain users to discontinue use while developing a software fix. Over the course of two years, the company invested heavily in research and development to correct the device’s accuracy. However, the FDA ultimately determined that the proposed software updates were insufficient.

Working in close collaboration with the FDA, the company navigated the complexities of product discontinuation while ensuring a seamless transition for patients to alternative monitoring solutions—minimizing disruption to patient care.

Solution

Sedgwick Brand Protection developed a comprehensive, end-to-end recall management strategy to ensure full compliance with FDA regulations while efficiently orchestrating notification and response, data management, product retrieval, and secure disposal. Our solution included:

• Targeted notification and outreach – due to the device’s distribution through third-party channels, the manufacturer had limited access to direct customer data. To address this, we engaged distributors nationwide to compile a comprehensive master patient database, enabling precise, targeted communication with affected users. This proactive strategy ensured efficient outreach, with impacted patients only.
• Global multilingual call center support – we rapidly launched and staffed multiple call centers, establishing more than 40 toll-free numbers across various countries and languages. This ensured seamless inbound and outbound communication with patients, healthcare providers, and distributors, providing expert guidance in their preferred language.
• Coordinated return logistics – Sedgwick Brand Protection managed the end-to-end process of assembling, shipping, and retrieving return kits, allowing the manufacturer to focus on other critical aspects of the recall.
• Optimized compliance and cost efficiency – recognizing the device’s blood-related use, we advised the inclusion of alcohol wipes and decontamination instructions in return kits. This proactive measure eliminated the need for biohazard labeling, ensuring regulatory compliance while minimizing transportation and disposal costs.

Résultats

A steadfast commitment to patient safety, regulatory compliance, and operational efficiency enabled the company to effectively navigate the recall, protecting both consumers and brand integrity.

• Outstanding call center execution – the recall communication strategy surpassed expectations, maintaining ongoing engagement with patients, healthcare providers, and distributors across all regions, ensuring clarity and compliance at every touchpoint.
• Advanced data management – Sedgwick Brand protection’s proprietary platform centralized all recall-related data, providing real-time visibility into recall progress while streamlining regulatory reporting and compliance.
• Exceptional product return rate – despite the inherent challenges of retrieving in-home medical devices, a strategic approach to communication and logistics yielded a return rate significantly exceeding industry benchmarks.

Principaux enseignements

• Proactive engagement with distributors, customers, and regulators is essential in medical device recalls. Transparent, continuous communication throughout the lifecycle of the event builds trust and mitigates the risk of unforeseen regulatory intervention.
• Regulatory outcomes can be unpredictable. Even after implementing corrective measures, authorities may still require product withdrawal. A robust recall management strategy ensures agility, compliance, and rapid response to evolving regulatory mandates.
• Patient-centric communication is paramount. Delivering clear guidance, readily accessible support, and proactive assistance in transitioning to alternative solutions enhances recall effectiveness while safeguarding public health and trust.

À propos de Sedgwick Brand Protection

Brand and reputation are the most valuable and vulnerable assets a business has. Brands embody everything a business does, and its customers expect.

Nothing says more about a company’s commitment to its customers than its efforts to uphold promises of safety, quality, and service. That’s why companies are often remembered more for how they handle an in-market challenge than for the problem itself. We know what it takes to manage recalls in a way that upholds your commitments to customers, supply chain partners, and regulators.

Trusted by the world’s leading brands and businesses, Sedgwick Brand Protection works in partnership to manage the risks and minimize the impacts of in-market business and product crises. Since 1995, we have managed more than 7,000 of the most sensitive and time-critical product recall and remediation programs, spanning 150+ countries and 50+ languages.

To discover more about our product recall and incident response solutions, visit: www.sedgwick.com/product-recall

World

leading

medical device manufacturer

Mondial

multilingual call center established

40

country toll free numbers set-up

Inbound and outbound

capacity