CRITICAL RESPONSE: ENSURING MEDICAL DEVICE SAFETY
We are proud to partner with 7/10 of the world’s leading medical device brands.
Medical devices play a pivotal role in patient care, but they also harbor inherent risks. Their criticality underscores the need for manufacturers to prioritize immediate and effective responses to any safety concerns. Failure to act promptly not only jeopardizes patient well-being but also amplifies the reputational and financial fallout.
Continuous surveillance and stringent quality safety protocols are indispensable. Manufacturers must remain vigilant, conducting ongoing evaluations to swiftly identify emerging issues. Proactive monitoring allows for timely interventions, averting potential risks to patient health while mitigating the broader impact on the company’s reputation and viability in the industry.
Since 1995, we’ve partnered with the world’s leading medical device brands to develop, test and execute over 7,000 product recall and remediation programs across 100 countries and 50 languages.
Whether you’re planning for — or currently facing — a product recall, market withdrawal or any other in-market product incident, our experts are on hand to support you.
PRODUCT RECALL MANAGEMENT FOR DEVICE MANUFACTURERS
Expert guidance in developing, testing, and executing comprehensive product recall plans.
The threat posed by medical device failures to patient well-being necessitates manufacturers maintain vigilant monitoring. As the industry evolves, emerging risks such as cyber-attacks targeting connected devices underscore the crucial need for robust recall readiness and swift corrective action to address device vulnerabilities.
Alongside cyber threats, a myriad of other risks including mounting supply chain pressures, enhanced pathogen detection, heightened regulatory scrutiny, and the growing influence of digital health have contributed to a 6.5% increase in global device recalls in the past 5 years.
With three decades of industry experience, we are uniquely qualified to address the most intricate of medical device product recalls and corrective actions. Whether navigating complex regulatory demands and compliance specifications, orchestrating seamless patient notification and response programs, or managing product retrieval, field repair or device destruction – we have the experience to help.
For over a decade, Sedgwick brand protection has published its quarterly Recall Index report. Downloaded in more than 100 countries, the Index has established itself as the definitive guide to medical device safety. Access high-level insights below and download our latest edition in full.
U.S. MEDICAL DEVICE SAFETY & RECALL INSIGHTS
Quarter 3, 2023
The number of medical device recalls decreased by 7.9%, with 222 events in Q3 2023 compared to 241 recalls in Q2 2023. The number of impacted units dropped by 63.1% to 24.48 million this quarter. Quality issues were the leading reason for recalls in the sector, accounting for 49 events in Q3 2023. Mislabeling concerns were the second-most common cause with 29 events, followed by safety with 24 recalls.
In terms of impacted units, parts issues was the top reason for recalls in Q3 2023, affecting 7.62 million devices, including two separate recalls for probe covers that impacted 5.61 million and 1.51 million units, respectively. Sterility issues affected the second-highest number of medical device units with 5.19 million in Q3 2023. Concerns about false results affected 2.77 million units, followed closely by quality issues which impacted 2.76 million units.
The number of recalls across all Class designations of medical devices fell from Q2 to Q3 2023, as did the number of units recalled in each category. The number of units involved in Class I events fell from 15.74 million in Q2 to 649,124 in Q3 across 19 events. The volume attributed to Class II recalls decreased by 52.9% quarter-over-quarter. Even more significant was the drop in Class III units, which fell by 97.0% to 1,112 units in Q3 compared to 37,574 units last quarter.
Quarter 2, 2023
The number of medical device product recalls decreased to 241 events in Q2 2023 from 252 recalls in Q1 2023. Looking at H1 as a whole, the 493 recall events recorded in H1 2023 are up 10.3% on the 447 recorded in H1 of 2022.
Quality issues were the leading reason for product recalls in the sector, accounting for 38 events. Parts issues were the second-most common concern with 27 events, followed by software, and mislabeling which both recorded 20. In terms of units impacted, sterility concerns led to the recall of 21.1 million medical devices in Q2 2023.
The number of Class I medical device product recalls increased 71.4% to 24 events in Q2 2023, which represents the highest quarterly figure for Class I designations in over ten years.
Quarter 1, 2023
The number of medical device product recalls marginally increased in Q1 2023 with 252 events compared to 241 recalls in Q4 2022. There was a more dramatic uptick in the number of impacted units, which rose by 34.3% to 83.3 million this quarter.
Manufacturing defects were the leading reason for medical device product recalls, accounting for 59 events or 23.4%. Parts issues were the second-most common concern and were linked to 38 events.
In terms of units impacted, quality concerns accounted for 68.5 million units, or 82.3% of all products recalled in Q1. A single recall for 66.5 million CADD infusion sets was responsible for 79.8% of all units recalled across the sector.
EUROPEAN MEDICAL DEVICE SAFETY & RECALL INSIGHTS
Quarter 3, 2023
Across the UK and EU, there were a total of 886 medical device recalls in Q3 2023. This is an increase of 17.2% compared to Q2 2023. It is also the highest quarterly total since Q1 2021.
Software was the most common reason for Q3 2023 medical device recalls with 114 events, a 14.0% increase from Q2 2023. Safety concerns was the second-most cited issue, accounting for 106 recalls. There were 82 recalls for device failure, making it the third-most common cause of recalls this quarter, though it also marks a significant drop from the 102 device failure recalls in Q2.
In Q3 2023, Germany issued the most recall notifications for medical devices with 199, the same number it had in Q2 2023. France also had the same number of recalls as it did last quarter, holding its position as the second-highest issuer with 197 notifications. Italy was third with 169 notifications, on par with its 166 alerts last quarter.
Quarter 2, 2023
There were a total of 756 medical device product recalls across Europe in Q2 2023. This is down slightly from 790 events in the previous quarter. Despite this decline, at the halfway point of the year, product recall activity is up 13.0% from H1 2022.
Device failure was the most common reason for product recall in Q2 2023 with 102 events. Software concerns were the second-most cited issue, accounting for 100 events. The number of product recalls linked to medical device safety fell by 21.6% to 76 in Q2 2023.
Germany issued the most recall notifications with 199, a 6.4% increase from Q1 2023. France was the second top issuer with 197 notifications, followed by Italy with 166 recall events.
Quarter 1, 2023
There were a total of 790 medical device product recalls across Europe in Q1 2023. This represents a 6.8% uplift on the 740 events recorded in Q4 2022. Software issues were the most common reason for recall, with 115 events. This reflects an 18.6% increase from the 97 events recorded in Q4.
Safety concerns were the second most cited issue, accounting for 97 product recalls, a 70.2% increase from last quarter. That was followed by device failure with 89 events and outside of specifications with 65 events.
France issued the most product recall notifications for medical devices with 205, a 15.8% increase from the previous quarter. Germany was the second top issuer with 187 notifications, down 12.6% from the previous quarter.
MEDICAL DEVICE REMEDIATION
While not every device issue mandates a formal recall, swift and cautious action is indispensable in ensuring patient safety.
Whether regional, national or global in scale, protecting patients and brands from defective devices in the marketplace requires speed. In the event of a medical device market withdrawal, product recall or consumer complaint, our global team of field representatives mobilizes within 24 hours to correct faulty medical devices on-site, install software updates, retrieve devices for disposition, or return them to manufacturers for testing. Our fast and effective on-site visits allow for the retrieval of affected products, while follow-up audits verify that medical devices were removed or repaired properly.
Leveraging three decades of industry experience and expertise, our proven best practice strategies and executional proficiency provide comprehensive support to medical device manufacturers. Our global on-site device corrections span hospitals, physician’s offices, and even patient homes, ensuring swift and accurate repair or removal of potentially harmful devices from the market.
INDUSTRY-LEADING CALL CENTER SOLUTIONS
With Sedgwick Brand Protection, gain 24-7-365 access to a global team of brand ambassadors ready to field calls from concerned patients.
Our expertise extends beyond the handling and resolution of product recall inquiries, to encompass a wide range of business and drug related challenges – from market withdrawals, product safety alerts, corrective action programs, and much more. Since 1995 we have provided the medical device industry with:
- Instant on-demand support that adds flexibility and agility to existing customer engagement infrastructures, alleviating pressure on resources as call volumes surge – ensuring vital day-to-day business operations are not compromised.
- Scalability in size and duration, from short-term engagements to long-term programs in response to one-time product recalls or persistent issues. Flexibility on-demand – simply dial up and down as required.
Recalling a medical device critical to patient health when regulators demand 'immediate' action.
End-to-end recall management, including a 40+ country multi-lingual call center operation.
Download our Recall Index
Essential insight and analysis for mitigating product recall risk
SEDGWICK BRAND PROTECTION
The world's leading product recall company
For over 25 years, companies of all sizes and sectors have trusted our expertise in preparing for and managing their product-related challenges. Since 1995, we’ve successfully managed more than 7,000 of the most sensitive and time-critical product recall programs, spanning 100 countries and 50 languages.
Whether your in-house teams need scalability to maintain daily operations during a product crisis, or you require a complete end-to-end product recall solution, we have the experience to protect your brand and peace of mind.
If you’re currently facing a product recall, or seeking to enhance your recall readiness, contact us now.
Whether you’re planning for — or currently facing — a product recall, market withdrawal, or any other in-market product incident, our experts are on hand to support you.