Abbott/St Jude RECALL

Does anyone have any further info on this Pacemaker recall?

FDA Recalls 60,000 Abbott Pacemakers Due to Defect (aarp.org) The 61,973 Scalable Bradycardia Platform (SBP) pacemakers were sold under the Assurity and Endurity model names between April 29, 2015, and Feb. 20, 2019. The implantable pacemakers detect when the heart is beating too slowly and send a signal to the heart to make it beat at the correct pace. The pacemaker manufacturer was formerly known as St. Jude Medical before merging with Abbott in January 2017.


6 Comments

DEVICE LOOK UP CHECK

by WazzA - 2021-05-26 19:45:53

Pacemaker Safety Notification Lookup | Abbott (cardiovascular.abbott)

Recall

by AgentX86 - 2021-05-26 22:51:09

It seems to be a real problem but a very low probability (.049%).  That means that of 68000 patients, 33 will experience such a failure.  That said, I certainly wouldn't want to be one of the 33 (dependent - no escape).

Abbott Safety Notification

by Marybird - 2021-05-27 00:35:06

Wazza, your post was the first I had heard of Abbott's safety notification. I checked out the information on several sites, it's not a recall but a notification of potential problems with some of Abbott/ St. Jude Endurity and Assurity single and dual chamber pacemakers. Apparently people with devices affected by this safety notification ( ie, pacemakers made from 2015 to Feb 2019), and their doctors received letters from Abbott notifying them about these problems in March 2021. The instructions were NOT to replace the pacemaker, unless a problem occurred, and the number of people impacted was expected to be very low.

I have a St. Jude Assurity PM model 2272, one of the models potentially affected by this notification, though I had it implanted in June 2019, after the dates listed in the notification. I used the information in your second post, Wazza, to access the Abbott site where you can input your Endurity of Assurity PM model number and serial number, and determine if your pacemaker is affected by the safety notice. I was informed my pacemaker was NOT affected. Whew!!

Thanks for the heads up, and information. 

look up address

by Tracey_E - 2021-05-27 09:15:09

https://www.cardiovascular.abbott/us/en/hcp/product-advisories/pacemaker-lookup.html

I have one of those implanted in 2016 so I looked it up, not on the list. I'll point out that this one has already lasted almost as long as my last one, previous replacement 2010.

Abbott Assurity Recall

by Going Forward - 2021-05-27 14:28:50

Thanks for giving the address to look up model and serial number. My Assurity was implanted during the dates mentioned and it wasn't clear from news reports that only some of my model (2272) were affected. A search on the Abbott site wasn't useful. This morning I put in my model and serial number and mine was not one of those effected. 

Important

by ROBO Pop - 2021-05-27 21:35:58

It is important to stay abreast of news and do your homework. My hardware has been recalled 3 times and I was never notified by the manufacturer or my EP. In fact the first two back in 07 I found out about here. There is a govm't website, sorry don't remember address off the top, that posts that info. I strongly recommend monitoring the site as interesting how the mfr said my CRT-D was not part of the recall but the government site said it was. Turns out it was. As an aside all mfr have had recalls and all have handled them poorly at one time or another. 

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