Knowledge base

An open research library covering medical devices, prescription drugs, consumer products, environmental exposures, and the litigation around them.

Medical devices

Bioabsorbable PLLA/PLGA Interference Screws: What Patients Should Know About Complication and Failure Risks

Bioabsorbable PLLA/PLGA interference screws carry a 73% higher risk of treatment failure and a more-than-threefold higher complication rate than metallic screws, according to a 2026 systematic review. If you had ACL reconstruction or ankle repair with a bioabsorbable screw, here is what the evidence shows and what steps to take.

June 02, 2026 · 8 minute read

Medical devices
GORE-TEX® Stretch Vascular Graft: What Patients Should Know About Long-Term Calcification

Published research has linked GORE-TEX® Stretch Vascular Grafts to dystrophic calcification — calcium deposits inside the ePTFE walls that can stiffen the graft and reduce blood flow. A 2024 Nature Communications study found ePTFE grafts accumulated an average calcium burden nearly 2,700 times higher than tissue-engineered alternatives. Here is what patients with this implant should know.

June 02, 2026 · 7 minute read
Medical devices
iLet® ACE Pump (Beta Bionics): Safety Alerts, FDA Warning Letter, and What Patients Should Watch For

The FDA issued a Warning Letter to Beta Bionics in January 2026 citing 529 insulin cartridge leak complaints, 107 serious-injury reports involving severe hypoglycemia, and an unreported cybersecurity vulnerability that allowed unauthorized changes to pump settings. The iLet ACE Pump remains on the market. Here is what current users should know and do.

June 02, 2026 · 10 minute read
Medical devices
Implanted Peripheral Nerve Stimulation Systems: What Patients Should Know About Complications, MAUDE Reports, and Active Litigation

A 2025 peer-reviewed analysis of FDA adverse-event reports found that nearly half of all reported complications from implanted peripheral nerve stimulators ended in surgical removal. Infection, lead migration, and unexpected shocks were the most common problems. With active litigation underway against major neurostimulator manufacturers, here is what patients with these devices should know.

June 02, 2026 · 11 minute read
Medical devices
Omnipod 5 Pods Recall: Internal Tubing Tear, Insulin Leakage, and What to Do

A manufacturing defect in certain Omnipod 5 Pod lots causes insulin to leak silently inside the device — no alarm fires, the pump appears normal, but you may be receiving far less insulin than prescribed. The FDA escalated Insulet's voluntary recall to Class I in April 2026, with 476 serious injuries reported. Here is how to check your lots and what to do.

June 02, 2026 · 9 minute read
Medical devices
True Metrix Blood Glucose Monitoring Systems: The E-5 Error Code, the 2026 Class I Recall, and What Patients Need to Know

When a True Metrix blood glucose meter reads above 600 mg/dL — a hyperglycemic emergency — it displays the same "E-5" error code it shows for a bad test strip. The FDA classified this a Class I recall after 114 serious injuries and one death were reported, and recommends switching to an alternative meter. Here is what users need to know.

June 02, 2026 · 9 minute read
Medical devices
ePTFE in Your Implanted Medical Device: A Patient's Guide

Information about long-term calcification in ePTFE devices has not always been emphasized in patient materials, though the medical literature has documented this issue for decades.

April 30, 2026 · 9 minute read

Knowledge base

Bioabsorbable PLLA/PLGA Interference Screws: What Patients Should Know About Complication and Failure Risks

GORE-TEX® Stretch Vascular Graft: What Patients Should Know About Long-Term Calcification

iLet® ACE Pump (Beta Bionics): Safety Alerts, FDA Warning Letter, and What Patients Should Watch For

Implanted Peripheral Nerve Stimulation Systems: What Patients Should Know About Complications, MAUDE Reports, and Active Litigation

Omnipod 5 Pods Recall: Internal Tubing Tear, Insulin Leakage, and What to Do

True Metrix Blood Glucose Monitoring Systems: The E-5 Error Code, the 2026 Class I Recall, and What Patients Need to Know

ePTFE in Your Implanted Medical Device: A Patient's Guide