Medtronic Recall Turns One – Are FSNs Enough?

When it comes to medical device safety, nothing grabs attention like a product recall. It’s the regulatory red flag that something has gone seriously wrong—whether it’s a malfunction, mislabelling, or a risk to patient safety. But behind every recall is a system designed to minimize harm and maximize transparency: the Field Safety Notice (FSN).

So what triggers a recall? How are FSNs involved? And how can we and healthcare providers respond effectively?

Let’s take a closer look.

What Is a Medical Device Recall?

A recall is a formal action taken by a manufacturer (or ordered by a regulator) to correct or remove a medical device from the market. This may be due to:

• A safety defect (e.g., device malfunction or breakage)

• A regulatory noncompliance (e.g., missing UDI or incorrect labeling)

• A risk of harm to users or patients

Recalls may involve a complete withdrawal of the product, or a correction via service updates or part replacements.

What Is a Field Safety Notice (FSN)?

An FSN is a formal communication from a medical device manufacturer to users, such as hospitals or clinics, alerting them to a safety-related issue or required action concerning a product currently in use.

Think of it as a manufacturer’s “heads-up” when something needs to be corrected, updated, or clarified—but without pulling the product entirely off the market.

In the UK, FSNs are submitted to the MHRA, and in Europe, to EUDAMED under the MDR/IVDR framework.

Here’s a look at real scenarios we’ve handled so far:

2024: 28 Recalls/FSNs
2025 (to date): 11 Recalls/FSNs

Key Examples:
Recall – Medtronic McGrath Handle
Initiated in July 2024 due to a reported incident. Approximately 2,000 devices and 150 customers were affected.

FSN – Mediplast Exudrain Mini FG 8 with Trocar
Issued for incorrect label data—the product itself was unaffected. A total of 19 devices and 6 customers were impacted.

Recall – Medtronic Shiley 7CN80R
Actioned due to reported harms, affecting 10 products and 5 customers.