Post-Market Surveillance
81 articles
Ultrasound Board-Level Failure Patterns: An HTM Field Guide to Root-Cause Diagnosis
A comprehensive HTM guide mapping ultrasound console symptoms to board-level failures (PSU, beamformer, motherboard) with FMECA data and repair-vs-replace rules.
Ultrasound Probe Repair vs Replace: An HTM Decision Framework With MAUDE Evidence
A detailed guide for HTM and biomedical engineering teams to evaluate whether to repair or replace diagnostic ultrasound transducers based on failure modes, safety risks, and compliance.
Coronary & Peripheral Stent Recalls: Boston Scientific, Abbott & Medtronic Teardown
A manufacturer-spanning deep dive into FDA stent recalls and MAUDE adverse event reports. Analyzes 131 recalls, common failure modes, and recent 2025-2026 high-acuity events.
ESU Recalls: ConMed, Stryker, Megadyne & Olympus Surgical-Fire and Burn Teardown
A manufacturer-spanning deep dive into FDA electrosurgical unit (ESU) recalls and MAUDE adverse event reports. Analyzes 640 recalls, surgical fire risks, and QMS implications.
External Defibrillator & AED Recalls: ZOLL, Stryker, Philips & Cardiac Science Teardown
A manufacturer-spanning teardown of automated external defibrillator (AED) and external defibrillator recalls and MAUDE events. Analyzes 373 recalls, common failure modes, and QMS implications.
Baxter FDA Device Footprint: 510(k), PMA, Recall & Manufacturing Analysis
A comprehensive data-driven regulatory profile of Baxter's FDA clearances, PMA approvals, safety recalls, and manufacturing hubs after the Hillrom acquisition.
Becton Dickinson (BD) FDA Device Footprint: 510(k), PMA, Recall & Manufacturing Analysis
A comprehensive data-driven regulatory profile of Becton Dickinson's FDA clearances, PMA approvals, safety recalls, and manufacturing hubs after the 2026 Waters spin-off.
FDA Ventilator Recalls: Class I Events, MAUDE Deaths & Root-Cause Analysis (2024–2026)
A data-driven analysis of FDA ventilator recalls, MAUDE database adverse events, root-cause categories, and major Class I events from Vyaire, Hamilton, Baxter, and Philips.
FDA 510(k) Predicate Best Practices: Recall History, Creep, and the 2026 QMSR Gate
A regulatory strategy guide analyzing the FDA's predicate-selection best practices, predicate-creep recall risk, and the 2026 QMSR parallel gate.
North Macedonia Medical Device Registry: MALMED Teardown & Analysis
A comprehensive analysis of North Macedonia's MALMED medical device register, detailing risk classifications, product categories, and local registrant landscapes.
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.