Post-Market Surveillance
81 articles
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 FDA's 2025 draft guidance targets skin-tone accuracy bias.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.
FDA MAUDE Trends 2020–2025: 14.4M Reports, Diabetes Dominance, Rising Deaths
Analysis of 14.4M FDA MAUDE adverse event reports (2020–2025) shows diabetes devices account for over half of all events. Death reports rose 63% from 2020 to 2024.
FDA Medical Device Recalls Decoded: 58K Records, Root Causes, and Trends
Analysis of 58,374 FDA device recalls shows 85.8% are Class II, device design is the leading identified root cause at 13.0%, and annual recall volume peaked at 3,313 in 2017.
EU MDR Post-Market Surveillance Plan: MDCG 2025-10 Practical Guide
Build a PMS plan aligned with MDCG 2025-10 guidance: proactive data collection, QMS integration, trend reporting, PMS reports vs PSURs, and custom-made device obligations.
FDA Adverse Event Monitoring System (AEMS): What Replaced MAUDE for Medical Devices
FDA replaces MAUDE with AEMS — unified adverse event dashboard, migration timeline, data limitations, and reporting changes for device manufacturers.
Swissmedic 2026 PMS Focus Campaign: What Class IIa/IIb/III Manufacturers Must Prepare Now
Swissmedic 2026 PMS focus campaign guide for Class IIa, IIb, and III devices, covering PMS plans, PSURs, PMCF data, complaints, trend analysis, and preparation.
EU MDR Article 10a: Supply Chain Discontinuation and Shortage Prevention
Learn when manufacturers must report device interruptions under EU MDR Article 10a, who to notify, required data, supply chain flow, and 2026 guidance.
EU MIR Form 7.3.1 Mandatory Update: What Changed From Version 7.2.1 and How to Prepare
Prepare for EU MIR Form 7.3.1, mandatory from May 1, 2026, including changes from 7.2.1, reportability fields, UDI issuing entity selection, EUDAMED XML, and vigilance updates.
FDA Medical Device Warning Letter Trends 2024-2026: Enforcement Analysis
Data-driven analysis of FDA medical device warning letter trends from 2024 to 2026, including common violations, QMSR shifts, notable actions, and compliance lessons.
Depot Repair QMS for Reusable Medical Device Capital Equipment
How to build a depot repair QMS for reusable capital equipment, covering intake, decontamination, testing, rework, calibration, nonconformance, release, and ISO 13485 records.
FDA Servicing vs Remanufacturing Decision Tree for Medical Devices
Classify medical device repair, maintenance, software, and modification work under FDA's May 2024 servicing versus remanufacturing guidance.