Class II Medical Device Compatibility Issue - Removal or Market withdrawal?



Hello, Please help me, I am so tired of combing the internet for vague answers.

We have a Class II device, this device is electronic and is used in conjunction with other manufacturers products, for example with patient return electrode pads that are made by several different manufacturers.

We have recently discovered that our device is not compatible with one manufacturers patient return electrode pads. We have a fix for that and want to offer it free of charge to the customers that have already purchased the device. We did not state in the IFU or marketing literature all of the compatible patient return electrode pads, only that the system will only work with compatible products.

We would like to offer it to the customers that purchased the device already the option to return the product so we could modify it so it works with this particular patient return electrode pads (while also still working with all of the other pads), but as long as they don't use that particular set of pads the device works as intended with all other pads we've tested.

Would this be considered a Removal, Market withdrawal, or something else?

I don't feel it would be reportable as there is no safety risks or violations.

Please help me, I am at my wits end.


katastic - that is actually a situation that you are usually not alone aas other companies have experienced similar instances.

My first comment is that in my own humble opinion this would not be considered under a recall, market withdrawal, or removal, because there is not a volatile situation that you are correcting. Now in your specific instance, if your device being incompatible with the other device manufacturer's product causes issues, dangerous situations, or may lead to patient harm, then yes, you would fall under the recall/removal instance. If you make a device that works with many other devices and find one that is not compatible or even a new manufacturer's product that is not compatible, i.e. can not plug in or attach, then this is just a design change on your part. In fact, if your product can not be plugged in or attached, then there should technically be no risk, thus no patient risk.

I agree with your assessment that this would not be reportable because there is no safety concern or violations of the regulations. Just make sure that you fully document any design change that you make accordingly including doing a revised risk assessment. My second comment is, don't call it a "fix" because that eludes to a problem. Is it really a problem? Or is just new information gained from post market surveillance that requires a design change? Call it what it is: a design change.

There is probably not much on the internet that is useful, but definitely go back to the definition of a market correction by the FDA under 21 CFR 806 and recalls under 21 CFR 7. Really determine AND DOCUMENT your rationale for this design change not being a volatile situation requiring reporting. Also recommend looking at other guidance like Health Canada guidance on recall and the MEDDEV 2.12/1 that gives some other definitions and examples of recall/withdrawal situations.

Ronen E

Problem Solver
First of all, I would capture the issue as a customer complaint (even if it wasn’t expressed as such) and handle according to your relevant SOPs. This will allow orderly feeding into your PMS system and will trickle down through your QMS to wherever relevant. The fact that your labelling doesn’t commit to compatibility with 100% of market-available products should not prevent orderly analysis and decision making; it can be factored in when you get to the point where you decide what to do about it, down your SOP.

Second, it’s important to analyse/clarify what does it mean “is not compatible with”. Is there any risk in the situation? Is it obvious that co-use is impossible (eg connector mismatch), or can someone try to use it mistakenly?

If no risk (or the risk acceptably low), it’s important to clarify the nature of the “fix”. If it involves changing something in the original device, I agree it’s a design change. Either way, you should manage this as a new/separate (mini?) project. If it’s a design change, manage it as a design change and take care of the regulatory questions - is a special 510(k) required? Maybe just a letter to file? Etc. If you’re adding an accessory, manage it accordingly. And so no. Just don’t do it “on the fly”. The facts that there was no labelling breach, that there are alternatives, that this involves few customers / few products etc. don’t matter. It’s still what it is (and you need to define what it is first).

I wouldn’t recommend referring to other jusrisditions’ guidance documents, as sometimes concepts and attitudes differ, and at the end of the day the FDA is not committed to other jursdictions’ views and practices (except where FDA explicitly says otherwise).

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