AMS Ms pump recall

[Stewy78]

Hi,
If you check my history you can see that I had my first implant on January this year. Pump stopped working after a few months, on June I had it replaced. New pump is not working properly again.
Both my pumps are affected by a manufacturing issue and both are subject to a recall. You can see the recall at the following link

https://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2020/74087r-eng.php

I also attach the official recall pdf from Boston scientific with the affected material numbers.

Now i will have to do another surgery, it's crazy I have no words about this.. I'm really really sad.

[Waynetho]

How odd, the product model number for my pump is listed in the 18cm Preconnect but the 15cm preconnect doesn't show that model. Also, mine was not "preconnect" it was assembled onsite.

What does this mean for USA implantees though since this recall is a CANADIAN government recall.

[C_lab34]

So sorry to hear of what you are going through. I know the hurt and disappointment you are feeling. I am hoping that at least you will be reimbursed for all your trouble, and not have to pay for another surgery. Plus, if it is just the pump, the surgery will be less invasive. Hang in there, man.

[Stewy78]

Recall is global. For example you can find the same recall from italian government here( I live in Italy)
http://www.salute.gov.it/portale/news/p3_2_1_3_1_1.jsp?lingua=italiano&menu=notizie&p=avvisi&tipo=dispo&id=9707

In my previous post I attached the official boston scientific statement with all the serial numbers affected

[newbie443]

Seems to indicate a lot of men are going through the same thing. Really feel bad for all of them. The OP attachment of his recall letter has a link to check if your device is part of this recall. You do need your model/part number and Serial/lot number to check. This is the link. https://www.bostonscientific.com/en-US/ ... -tool.html

[Waynetho]

What sucks is the recall almost certainly covers only the hardware but the implantee is responsible for the installation and medical care during and after (hospital).

[Lost Sheep]

The first paragraph of the letter calls for a product removal of "unused inventory of the AMS 700 MS" pump. That suggests only those still on the shelf and not implanted yet.

The paragraph goes on to say that the problem typically only manifests itself in the first two months after implantation. The letter states "An MS Pump that is found to activate and function properly during the initial post-operative user interactions is not impacted by the issue described in this removal. In other words, as described below, other pump activation concerns your patients may have encountered in the past, or may encounter in the future, that did not manifest in the first two months after implant are NOT related to this product removal."

So, if you have had your MS pump installed for more than two months, the recall does not apply to you.

Apparantly a manufacturing problem in the molds used for about 2% of the pumps cause failure right away after implantation. If you don't get a failure within 2 months, that is (to AMS' mind) proof that you have one of the 98% of pumps that did not use that mold and therefore will not have this failure.

The letter concludes by repeating that most implants are not subject to the recall. "If a Pump is found to activate and function properly during the initial post-operative patient interactions the pump is not impacted by the problem described in this letter."

But they are apparently recalling all pumps still on the shelves, to ensure no future patients are troubled by the 2% of defective pumps.

But definitely NOT all pumps, not even those within the serial number ranges in the letter. "There is no need to
remove normally functioning devices."


So, as I read it, an unknown percentage of AMS pumps were made with a faulty mold with bad tolerances and a certain percentage of those were assembled with other components which, because of the out-of-tolerance dimensions of the one part, have problems. Those problems always manifest themselves within two months of operation. Therefore, if a pump is working after two months, even if parts of it came out of that faulty mold, the assembly (with the other parts) is proved to be OK. That is, the tolerances of the other parts allow for the out-of-tolerance dimensions of the one part.

I bet the QC folks at BSC are looking around and pointing fingers like crazy.

[ocitgo]

I had 2 that both failed. My doctor gave up too. So far no plans to redo it.

[indusvalley]

I had 2 that both failed. My doctor gave up too. So far no plans to redo it.

Did your AMS pumps fail both times? I had my mind set on getting LGX but this news of AMS pump recall has made me extremely nervous and confused. I am now wondering if I should continue with LGX or opt to get a Coloplast?

Any help from members in this forum will be appreciated. My penile size is pretty standard - 5 and half inch in length and 4 and half inch in grith.

Should I ask the doc to check serial number of pump against the list provided by AMS? Or should I just opt to go with Coloplast? I personally as a grower really liked the flaccid hang on LGX. So confused right now about what decision I should make.

[tomas1]

It would help to actually know the percentage of failures with the pumps. Mine works well so far. I would still go with the LGX but it's your decision.