Post-Market Surveillance
51 articles
FDA Insulin Pump Recalls: Medtronic, Insulet, and Tandem — A MAUDE and Class I Teardown
A comprehensive regulatory and clinical engineering teardown of FDA insulin pump recalls. Analyze manufacturer volumes, mechanical root causes, and MAUDE safety trends.
Philips CPAP Recall: PE-PUR Foam, 15 Million Devices, 561 Deaths Teardown
A detailed regulatory and quality system teardown of the Philips Respironics CPAP recall. Understand PE-PUR foam chemistry, the FDA consent decree, and MDR metrics.
FDA Dermal Filler Approvals and Adverse Events: A 30-Year MAUDE and PMA Analysis
A comprehensive, data-driven analysis of 1,038 FDA dermal filler PMA approvals and 22,247 adverse events from the MAUDE database, detailing trends, top brands, and safety profiles.
FDA Product Code FDT: A Quantitative Audit of Duodenoscope Recalls and MAUDE Events
An empirical, data-driven safety audit of FDA product code FDT (duodenoscopes). Analyze 31 classified recalls and 3,985 adverse events from the MAUDE database.
FDA Product Code NAY: Surgical Robotics Clearance and Recall Trends
A deep dive into FDA product code NAY (computer-assisted surgical systems) using active registry data. Learn about 510(k) clearance trends and recall root causes.
FDA 522 Postmarket Surveillance Studies: Section 522 Order Compliance Guide
Understand FDA Section 522 postmarket surveillance orders for Class II and III devices: triggering criteria, the 30-day plan and 15-month start rules, study design, and the public 522 database.
FDA Medical Device Recall Concentration: Top 50 Firms Drive Over Half of All Recalls
Analysis of 58,374 FDA recall records: recall burden is concentrated. The top 50 firms drive 52% of recalls while 42% of firms recalled only once. Zimmer Biomet, Philips, Stryker, and Medtronic lead.
FDA Orthopedic Implant Recalls: Zimmer Biomet Leads 3,167 Hip & Knee Recall Records
FDA recall analysis: 3,167 hip, knee, and shoulder joint-replacement recalls across 70 product codes. Zimmer Biomet holds 37%, the top-10 firms 87%, and 96% are Class II 510(k) devices, not PMA.
Adverse-Event Reporting Compared: FDA 21 CFR 803, EU MDR, Brazil, Thailand & SA
Side-by-side legal-text comparison of device adverse-event reporting: FDA 21 CFR 803, EU MDR Art. 87, Brazil RDC 67/2009, Thailand MoPH, SAHPRA — triggers, timelines, who must report.
Recall vs FSCA Compared: FDA 21 CFR 806, EU MDR, Brazil & Thailand
Side-by-side legal-text comparison of medical device field actions: FDA 21 CFR Part 806, EU MDR FSCA/FSN, Brazil RDC 551/2021, and Thailand recall guidance — triggers, timelines, filing objects.
FDA Breast Implant Recalls: Allergan, BIA-ALCL, and the 580,000-Report MAUDE Record
Breast implant analysis: 16 Class I FDA recalls (Allergan BIOCELL), 1,380 BIA-ALCL cases, and 580,000 MAUDE reports. Capsular contracture and implant failure lead complications.
FDA Pacemaker and ICD Recalls: 451 Enforcement Actions and the Lead-Failure Record
Pacemaker and ICD analysis: 451 FDA enforcement actions (188 Class I) and 558,000 MAUDE reports. Boston Scientific and Medtronic lead; software and lead-impedance faults dominate Class I.
FDA Surgical Mesh Recalls: 171 Actions and the Polymeric-Mesh MAUDE Record
Surgical mesh analysis: 171 FDA recalls, 15 Class II enforcements, and 145,000 MAUDE reports. Bard/Davol leads recalls and reports; the POP-mesh 510(k) line was pulled to Class III in 2016.
Hemodialysis Recalls: 821 Events Show the Burden Sits in Disposables, Not Machines
FDA hemodialysis recall analysis: 821 events across 26 dialysis codes — 96.6% in disposables and catheters, not machines. 82 Class I actions; Fresenius and Baxter lead.
Home Oxygen Concentrator Recalls: 44 FDA CAW Records and 11 Class I Actions
Home oxygen concentrator CAW recall analysis: 44 FDA recall records; 33 have enforcement classifications, including 11 Class I. Nidek leads the Class I fire record across 52,664 MAUDE reports.
FDA Infusion Pump Recalls: 1,180 Events and the Class I Software-and-Alarm Causes
FDA infusion pump recall analysis: 1,180 events, 189 Class I actions. Software and alarm defects dominate the most serious recalls, led by BD, Baxter, and ICU Medical.
Pulse Oximeter 510(k) Map: 726 Predicate Clearances and the FDA Pigmentation Reckoning
Pulse oximeter 510(k) analysis: all 726 DQA clearances are predicate-based, led by Masimo, Nonin, and Nellcor. FDA's 2025 draft guidance targets skin-tone accuracy bias.
FDA Surgical Stapler Recalls: 19 Class I Actions and the Misfire-and-Fragmentation Record
FDA surgical stapler analysis: 222 enforcement actions, 19 Class I recalls. Ethicon dominates the most-serious actions; malformation, misfire, and fragmentation lead, across 31,000 MAUDE reports.
How to Check if a Medical Device Was Recalled: FDA Recall Database Lookup
How to search the FDA recall database and Enforcement Reports to check if a device was recalled, what Class I/II/III means, and how to read a recall status — with data on recall volume and classes.
FDA Class I Device Recalls: 3,510 Events, Firms, and Trends Since 2006
3,510 FDA Class I device recalls since 2006, led by Medtronic, Boston Scientific and Teleflex. Catheters and ventilation devices drive a sharp post-2020 rise.