Rising incidents of patient deaths are raising questions about medical device efficacy, specifically Class II and Class III medical devices. All medical devices commercialized in the US market must adhere to 510(k) compliance. The US Food and Drug Administration (FDA) posts summaries of information about the most serious medical device recalls.
This study analyzes the latest US FDA recalls in the medical device market. It does this by examining the FDA's information summaries. This list includes devices recalled during the study period (2020–2028) as they presented specific risks to patients. The device types (according to US FDA classification) studied include:
• Class I recalls
• Class II recalls
In terms of recalls, devices that could cause serious health issues and even patient death are listed. Medical device recall notices reflect the date of posting on the government list and not the recall initiation date.
FDA Class I Recalls: The FDA Class I is the most crucial recall type. Using Class I medical devices may cause serious injuries or even death.
This recall occurs when a high probability exists that a violative medical device, through exposure or use, causes serious adverse health issues or patient death. Under statutory authority, the FDA can request, conduct, or order a Class I recall. As this recall type includes FDA requests, most companies voluntarily recall their device.
FDA Class II Recalls: An FDA Class II recall occurs when a medical device presents patients with a substantial health and safety hazard. Class II medical device recalls cover devices that have even a slight chance of causing serious injury or producing adverse health consequences, which may be temporary and medically reversible. The FDA issues a Class II recall where the risk of death or severe injury from the device usage is not immediate, but the danger remains.
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US FDA Medical Device Recalls
Medical Device Recalls—Segmentation
Growth Drivers
Growth Restraints
FDA Steps for Working on 510(k) Approval
US FDA Medical Device Recalls—2018–2023
US FDA Medical Device Recalls—Major Recall Reasons
US FDA Medical Device Recalls—Number of Recalls by Companies
Impact of FDA Recalls on Medical Device Market Participants
Recall 1—Fresenius Medical Care’s Recall of Hemodialysis Machines
Recall 1—Fresenius Medical Care’s Recall of Hemodialysis Machines (continued)
Recall 2—Philips Respironics’s Recall of V60 and V60 Plus Ventilators
Recall 3—Draeger Carina’s Recall of Sub-Acute Care Ventilators Because of Contaminants in Air Path
Recall 3—Draeger Carina’s Recall of Sub-acute Care Ventilators Because of Contaminants in Air Path (continued)
Recall 4—Covidien LLC (Medtronic) Palindrome and Mahurkar Hemodialysis’s Recall of Catheters
Recall 4—Covidien LLC (Medtronic) Palindrome and Mahurkar Hemodialysis’s Recall of Catheters (continued)
Summary of FDA Class I Medical Device Recalls
Product Recalls of Endoscopic Devices*
Product Recalls of Endoscopic Devices*(continued)
AER Product Recalls
FDA Communications on Reported Patient Endoscope- and AER-related Infections
Factors Leading to the Transition from Reusable and Reprocessed Duodenoscopes to Disposable Duodenoscopes
Increased Recommendations to Prevent Cross-contamination Risks Boosting the Flexible Single-use Endoscope Market
Case Study—How Boston Scientific Received Additional Centers for Medicare & Medicaid Services (CMS) Reimbursement for the EXALT™ Model D Disposable Duodenoscope
Summary of Endoscope and AER Recalls and Action Plans
Growth Opportunity 1: Innovative Chemical and Material Usage in Medical Devices
Growth Opportunity 1: Innovative Chemical and Material Usage in Medical Devices (continued)
Growth Opportunity 2: New Technology Innovation, such as Flexible Single-use Endoscopes and Disposable Sheaths
Growth Opportunity 2: New Technology Innovation, such as Flexible Single-use Endoscopes and Disposable Sheaths (continued)
List of Exhibits
Legal Disclaimer
List of Figures- FDA Medical Device Recalls: Growth Drivers, United States, 2024–2028
- FDA Medical Device Recalls: Growth Restraints, United States, 2024–2028
- FDA Medical Device Recalls: FDA Steps for Working on 510(k) Approvals, United States, 2020–2023 (October 2023)
- FDA Medical Device Recalls: Number of FDA Annual Recalls, United States, 2018–2023 (October 2023)
- FDA Medical Device Recalls: Number of Recalls by Reason, United States, 2020–2023 (October 2023)
- FDA Medical Device Recalls: Number of Recalls by Companies, US, 2020–2023 (October 2023)
- FDA Medical Device Recalls: Heat Map Indicating Potential Impact on Companies Post FDA Recalls, US, 2020–2023 (October 2023)
- List of Select FDA-recalled Endoscopic Devices, United States, 2020
- List of Select FDA-recalled AER Products, United States, 2021
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| Deliverable Type | Market Research |
|---|---|
| Author | Suchismita Das |
| Industries | Healthcare |
| No Index | No |
| Is Prebook | No |
| Keyword 1 | Medical Device Recall Trends |
| Keyword 2 | FDA Recalls Impact Analysis |
| Keyword 3 | FDA Compliance Insights |
| List of Charts and Figures | FDA Medical Device Recalls: Growth Drivers, United States, 2024–2028~ FDA Medical Device Recalls: Growth Restraints, United States, 2024–2028~ FDA Medical Device Recalls: FDA Steps for Working on 510(k) Approvals, United States, 2020–2023 (October 2023)~ FDA Medical Device Recalls: Number of FDA Annual Recalls, United States, 2018–2023 (October 2023)~ FDA Medical Device Recalls: Number of Recalls by Reason, United States, 2020–2023 (October 2023)~ FDA Medical Device Recalls: Number of Recalls by Companies, US, 2020–2023 (October 2023)~ FDA Medical Device Recalls: Heat Map Indicating Potential Impact on Companies Post FDA Recalls, US, 2020–2023 (October 2023)~ List of Select FDA-recalled Endoscopic Devices, United States, 2020~ List of Select FDA-recalled AER Products, United States, 2021~ |
| Podcast | No |
| WIP Number | K98F-01-00-00-00 |
US FDA Medical Device Recalls: Trend and Impact Analysis
Product Innovation will Reduce Medical Device Recalls
11-Dec-2023
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