Voluntary Recall of (some) Pipeline

Brain Aneurysm Foundation Brain Aneurysm Resources
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www.fda.gov/Safety/Recalls/ucm392987.htm?source=govdelivery& 04/11/2014

RECALL - firm Press Release...FOR IMMEDIATE RELEASE... April 11, 2014...

Pull it up...for your own review... (my comment)

Briefly: Covidien Implements Voluntary Recall...

Pipeline(tm) Embolization Device and Alligator(tm) Retrieval Device...

Re: coating used on some of it...

Covidien learned of this issue thru internal product testing....has not received any reports of patient injuries to date related to this issue...

(lower) A total o 32 Pipeline ...and 621 Alligator Retrieval Devices...affected by this recall...were manufactured and distributed from May 2013 to March 2014... and involves both (products) sold in the U.S., Australia, France, Germany, and UK... ands, the Alligator Retrieval Device, which is sold in the U.S., Australia, Canada, Europe and Latin America...

Covidien alerted customers to the recall by letter 04/01/14 and is arranging for replacement of the recalled products...

Adverse Reactions or quality problems experienced w/the use of this product may be reported to the FDA's MedWatch Adverse Events Reporting program either online, by regular mail or by fax.......

ABOUT COVIDIEN: ...leading global healthcare products company that creates med solutions for better patient outcomes and delivers value thru clinical leadership and excellence. Covidien develops, manufactures and sells a diverse range of industry-leading medical device and supply products. With 2013 revenue of $10.2 billion, Covidien has more than 38,000 employees worldwide in more than 70 countries, and its products are sold in over 150 countries. Please visit: www.covidien.com(http://www.covidien.com) to learn more about our business...

(I felt the right sense to post this positive data... No, I have no stock....)

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I am personally excited to have FDA MedWatch addressed here...I have discussed this w/some members...and, the limited reports on any BA procedural results...I can readily count those of us w/specific adverse events (some w/multiple adverse events during a procedure w/none of them reported)

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Wow, this sure is concerning. Can Pipelines be removed from the artery once they are inserted? That just seems really dangerous to take them out.

~ Carol

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Carol...I do not know...someone may want to take this data to the Groups on Pipeline/Ped...tho they may have had it before me...

One think I could not understand was the comment on "customers" being notified by 04/01... i.e. if that is the hospital doing the purchasing...or the patient being treated like a customer...(as we are in buying a new car...)

Sorry I posted it twice...I do not know how to delete the extra...likely simple...when my tech calls me back on my "picture program" training...I will ask him...I do not know how I managed to post it twice... probably something simple...

if you pull up the FDA website...you can probably check where to subscribe...for the emails...I have been subscribed for some time...so have no memory how/where I had signed up...

Pat...

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Hi Pat, thanks can you upload the Alert in the PED pipeline group sa well ?
Thanks

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Hi Giovanni...

Accessing / transferring data to a Group is yet a learning for me...

Can you just type in the FDA line noted above into the Groups?

Or search online: Covidien Recalls ... the Wall Street Journal article pops, too and, the FDA articles...and, other product recalls...

Online search is my old long-term memory...anything new warps my thought process...rely so on my tech for training / re-training...

Pat

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Well, maybe it is a great thing they couldnt get the PED deployed in me ;-)

scary.

Thanks for sharing

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Thanks for providing this...

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What a sad outcome for this patient. Imagine the stress the medical team was experiencing as well - what does one do?

Ed

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PED can’t be removed from what I understand. Vessels grow around it and ‘remodel’ the vein ( becomes part of the vein wall). I’ve read some studies finding ‘foreign’ material in clots forming well after PED placement in post-mortem exams. Scary but all I can do is hope for the best. There was no other way to treat my rupture and I have two PED placements!

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Oh my gosh! I am worried! Had mine put in between those dates! Would I have gotten a letter by now from my doctor?? Deb

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Me too! I’m not going to worry about it though. It is what it is and I’ve overcome too much to get ‘stuck’ on this. :0)

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Deb...

Prayers you'd have been contacted w/in a week+ by your doc ??? The article clearly states Covidien's letter was April 01 to customers...presumably they'd have mailed it...and, electronically transferred it immediately following their results to their main buyers...the purchasers at the hospitals...and the Covidien sales reps would certainly have stayed in close contact with the neuro-docs... during the research...

Please forgive me for having posted the FDA press release here on a Friday...tho that was the Press release day...for which I anticipated network and newspaper coverage...

Of interest, the only newspaper coverage on-line (available to me) was the WSJ...it was/is the third article down on my Google Search by reporters Joseph Walker and Erin McCarthy. This WSJ article is also dated 04/11/14...

My Implant Record...has the posted Lot #'s (coils/stent)...later I will share for more general info... on Lot #'s etc...

Prayers you not worry...assuming you'd have been notified in a timely manner...before the main press release...

Pat

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Thanks Pat…my check up is in a week or two and I’d like to make sure my Doc’s aware for other patients’ benefits!

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Sandy...thank you...

The WSJ article clearly states "recall affects about 650 products from certain lots of the company's Pipeline embolization device and Alligator retrieval device" and, those Lot #s are not listed in the press release...and, no clarity if the 32 means 32 Pipelines from various lots...or 32 lots...of how Pipelines?

My intent question is...how could some and not all be affected per certain lots?