Justpoint

06/29/2026

A new patient safety update is now live on our Knowledge Base.

The FDA has classified the Omnipod® 5 Pod recall as a Class I recall — its most serious type of medical device recall. Certain affected Pods may under-deliver insulin due to an internal tubing defect, potentially increasing the risk of severe hyperglycemia and diabetic ketoacidosis (DKA).

Our latest article explains:
• What the recall is about
• How to determine whether your Pods are affected
• Warning signs to watch for
• What steps to take if you suspect a faulty device
• Where to verify official recall information

If you or someone you know uses the Omnipod 5 system, staying informed is essential.

Read the full article here: https://justpoint.com/knowledge-base/omnipod-5-pods-recall/

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 injur...

06/26/2026

Medical devices can improve quality of life — but like any implanted technology, they also require ongoing safety monitoring.

A recent analysis of FDA MAUDE reports identified 594 medical device reports involving implanted peripheral nerve stimulation (PNS) systems in a single year, with many cases involving complications such as infection, lead migration, unexpected stimulation, and device removal.

Understanding these reports doesn't mean every patient will experience complications. It means patients deserve access to transparent information so they can recognize potential warning signs and have informed conversations with their healthcare providers.

That's why we've published a new guide covering:
• the most commonly reported PNS complications
• what FDA safety data tells us
• how to identify your implanted device
• what symptoms shouldn't be ignored
• where patients can report device-related adverse events

Read the full article:
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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 again...

06/25/2026

Medical devices are transforming diabetes care, but staying informed about safety updates is just as important as adopting new technologies.

Our latest article examines recent regulatory findings related to the iLet® ACE Pump (Beta Bionics), including:
• FDA Warning Letter issued after a manufacturing inspection
• Reported cartridge leaks and severe hypoglycemia incidents
• A cybersecurity vulnerability that was addressed through a software update
• Practical guidance for patients, caregivers, and healthcare professionals on what to monitor and how to verify whether their device is up to date.

The article is based on publicly available FDA documents and peer-reviewed research and is intended to help patients and clinicians better understand the current regulatory landscape and device safety considerations.

Read the full article here: https://justpoint.com/knowledge-base/ilet-ace-pump-beta-bionics/

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 m...

06/24/2026

How safe are synthetic vascular grafts over the long term?

New research continues to raise important questions about the durability of ePTFE-based vascular grafts, including the GORE-TEX® Stretch Vascular Graft. Published evidence suggests that dystrophic calcification may develop over time, potentially contributing to graft stiffening, reduced blood flow, thrombosis, and graft failure.

In our latest patient guide, we break down:
• what the GORE-TEX® Stretch Vascular Graft is
• what recent peer-reviewed studies reveal about calcification risk
• symptoms patients should be aware of
• how to identify whether this device was implanted during surgery
• questions patients may want to discuss with their healthcare providers

At Justpoint, we believe patients deserve clear, accessible information about the medical devices they rely on.

Read the full article:
🔗 https://justpoint.com/knowledge-base/gore-tex-stretch-vascular-graft/

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 hi...

06/23/2026

Many patients assume that once orthopedic surgery is over, the implanted hardware is no longer something they need to think about.

But what if complications can emerge years later?

Bioabsorbable interference screws made from PLLA or PLGA have been widely used in ACL reconstructions, ankle repairs, and other ligament procedures. Recent published evidence suggests these devices may be associated with higher rates of complications and treatment failure compared to metallic alternatives.

One of the challenges is that many patients don't even know which implant was used during their procedure.

Our latest article explains:
✔️ What bioabsorbable interference screws are
✔️ The complications reported in the medical literature
✔️ How patients can verify which device was implanted
✔️ What symptoms may warrant medical evaluation

Read more here: https://justpoint.com/knowledge-base/bioabsorbable-plla-plga-interference-screws/