Animas Cartridge recall

Got an email saying that my cartridges have bee recalled and not to use them. However, that’s all I have so I am going to continue using them until I get the new ones they are shipping. Perhaps this is a good reason for Animas to not send me all of the same numbered cartridges.

They say stop using them and go to my backup plan. I do not intend to start injecting again; I will just keep a sharp eye out until I get the new ones. Apparently they could leak but isn’t that true of any cartridge?

only certain lots are recalled. Not all of them.

Yes, mine were recalled.

I’m too new at pumping to have any practical advice, but if you have a minute to post the text of the e-mail you received, I’d be curious to see what that looks like.

I think this is also a reminder to all of us to keep a few cartridges that are from a different lot. I just started the Ping and only have the affected cartridges. For me it seeems to be every other one that leaks. I will play roulette until the replacements show up. This is just like when Minimed had their recall and all I had was the affected lot number.

Text of email:

February 22, 2011

Important Information about your 2.0 mL Animas Insulin Pump Cartridges

Dear Animas Pumper:

Animas Corporation is dedicated to supporting pumpers with quality customer service and products. As part of that commitment, we contact our pumpers whenever we have urgent information about our products.

We are sending you this email because we have learned that some of the 2.0 mL insulin cartridges shipped between Nov. 30, 2010 and Jan. 4, 2011 can leak insulin, resulting in the delivery of less insulin than intended. In addition, if the cartridge has a leak, the pump may not alarm if there is an occlusion in your infusion set.

Please note that under-delivery of insulin can cause high blood sugar and/or diabetic ketoacidosis. These are serious conditions that can cause severe health impact, including death.

Our records show that you have received a shipment with cartridges that have the potential to leak. It is important that you check your cartridge supply and stop using those cartridges immediately.

Cartridge lot numbers affected by this recall are:

You can find the lot number on the side panel of the cartridge box and on the packaging of each individual cartridge next to the symbol

What if I am currently using a cartridge with one of these lot numbers in my pump? Change your cartridge immediately using the following instructions. See your Owners Booklet or User Guide for more detailed instructions.

  1. Disconnect the infusion set from your body.
  2. Unscrew the cartridge cap, leaving the tubing connected to the cartridge.
  3. With the tubing connected to the cartridge, pull the cartridge straight out of your pump.
  4. Disconnect tubing from cartridge, set the cartridge aside to return to Animas.
  5. Fill a new cartridge from an unaffected lot not listed above, and attach infusion set tubing.
  6. Rewind, load the cartridge and prime.
  7. Connect tubing to site once prime is complete.

What should I do if we have unused cartridges from the lots listed above? Set them aside for return to Animas. We will be sending instructions and materials to return these cartridges.

What if I don’t have any other cartridges? Go to your back up plan for insulin delivery and call your healthcare professional if you have any questions about insulin dosing. We are in the process of notifying your Health Care Providers, but you may have received notice before we reached your doctor.

How do we get replacement cartridges? We plan to be shipping replacement cartridges free of charge no later than Friday February 25. You do not need to call Animas to order these replacements.

Is there anything wrong with my pump? No, there is not a problem with the pump. Any leaking of the insulin from the cartridge will not damage your pump.

Should I adjust my basal or bolus rates to correct the under-delivery of insulin? No. If you have an affected cartridge, stop using it immediately and replace it with another cartridge that is not affected, or go to your back up plan. Also, if you have any questions about adjusting your insulin dosing, contact your health care professional.

What if I have other questions?
If you have technical questions or concerns, please call Animas Customer Support at 1-855-254-5668 or you can call the toll-free number on the back of your pump at 1-877-937-7867.

Again, Animas is dedicated to providing our pumpers with quality customer service and products. We know that you had a choice when choosing the pump that would work best for your lifestyle and we appreciate that you trusted us. We assure you that we are doing everything we can to address this issue quickly to avoid any further concerns.


Animas Corporation

Note: In an attempt to make sure that we reach you, you may get more than one notice from Animas about this issue.

Animas Corporation, 200 Lawrence Dr., West Chester, PA 19380

If your’s were recalled, call animas and have them replace them. It’s better to go to your backup plan for a few days while you are waiting for the replacements for the recalled ones, than to risk going into DKA.

Weird, I too have all the recalled lot…however, I’ve had no problems with leakage. Animas says they are already going to send replacements…no need to call. I have emailed my endo re: this in case they have some spares.

I did call the company and they are overnighting a box of cartridges given that I have none that aren’t recalls. Also, I told the person I was going to keep using them so at that point she said, we’ll overnight some!

So I WOULD recommend calling if you have none backups.

I haven’t received this email, does that mean that I prob don’t have the affected batches?

The lot numbers for the recall are posted above. I’d check your lot numbers rather than assume your cartridges are ok. Especially if you get your supplies through a distributor rather than Animas directly.

I get my supplies through a distributor. When I was on Minimed and went through the Lot 8 quicksets recall it took a lot longer to be notified and to get replacements. Minimed didn’t notify the distributors right away and then it took them a few days to figure out who was going to do what in terms of replacing them. Fortunately my distributor had silhouette’s in stock and they sent me a box of those to tide me over.

Thanks for this information. I was not aware of the recall. I do not get my Animas 2020 cartridages direct from Animas. My HMO requires I get them through a medical supply place. Hopefully they would track lot numbers, but I do not know for sure. Fortunately, everything I have is Ok.

Thanks again

I received my replacements on Monday of this week and will mail the old ones back tomorrow. They were very prompt with this.


Yes, with mine as well…

Thanks for posting the email you received. My son is scheduled to have his saline startup on Monday and we did not know anything about this recall. We never received an email or anything. I checked his cartridges and all of them are on the list of recalled cartridges. Now what? I have a call into our rep.

Thanks again for the information!

Hi all, I had a cartridge o ring leak today, I know this is an old thread, but I just wanted to put this out there to find out if this is still happening. Woke up this morning with very high bg, manually corrected with a syringe to bring bg back down. I took the cartridge out and my ping was loaded with insulin inside the pump, I shook most of the insulin out and now I’m letting it drip dry, I am 3 weeks out of warranty and I hope the pump isn’t damaged, it still seems to work ok. This is the first time this has happened to me.

At first I didn’t realize this was an old thread and perhaps there was a recall I wasn’t aware of!

Did you call Animas about the leaky cartridge? This is known as an “adverse event” and they must report it to the FDA. It also might get Animas to ship you a replacement pump. It’s worth a try.

Could you please post the lot number of the cartridge involved? You may save someone else (like me!) the same trouble. Thanks.

Reply to Terry: I have not yet called animas to report this because I noticed that the bad cartridge was 9 months past expiration, I’m not so sure they would hear me out in that situation. The lot # B201874, Exp. 2014-06