MiniMedTM 630G and MiniMedTM 670G Insulin Pumps with clear retainer ring
The MiniMed™ 600 series insulin pumps with a clear retainer ring are eligible for replacement as part of an update to an existing recall. For more information about the recall, please visit the Product and Services Information Update page.
| CLEAR RETAINER RING PUMP (SUBJECT OF RECALL) |
BLACK RETAINER RING PUMP (NOT AFFECTED BY RECALL) |
|---|---|
 REQUEST REPLACEMENT PUMP |
 |
Recalled Products
MiniMedTM 630G and MiniMedTM 670G Series Insulin Pumps with a clear retainer ring.
Reason for Recall
Medtronic is recalling the specified insulin pumps to replace any pump that has a clear retainer ring with one that has the updated black retainer ring at no charge. A replacement insulin pump will be provided even if the clear retainer ring is not damaged and regardless of the warranty status of the pump.
Medtronic previously identified, and informed customers about the potential risk associated with a missing or broken clear retainer ring of the MiniMed™ 630G and 670G insulin pumps. The retainer ring helps to lock the insulin cartridge into place in the pump's reservoir compartment. If the cartridge is not locked firmly into place, under or over delivery of insulin may occur, which could result in low blood sugar (hypoglycemia) or high blood sugar (hyperglycemia). Severe hyperglycemia and hypoglycemia can be life-threatening or may result in death.
- Example of hypoglycemia risk - If the retainer ring is broken or becomes detached from the insulin pump, and the user inserts the reservoir back into the pump while the infusion set is still connected to the body, it could result in a rapid and potentially large infusion of insulin.
- Example of hyperglycemia risk - The under delivery of insulin could occur if the reservoir is not properly locked in place by the retainer ring, creating a space between the insulin pump and the reservoir, and prevents the pump from pushing the expected insulin into the body, or if the pump stops working due to water entering the insulin pump. This may also contribute to diabetic ketoacidosis.
Who May be Affected
- Any person with diabetes who uses an affected Medtronic MiniMedTM insulin pump with a clear retainer ring, or has one as a backup pump
- Health care providers who treat people with diabetes using the affected MiniMedTM insulin pumps
What to do
- Examine the retainer ring on your pump (current or backup) to determine if you have a clear retainer ring and whether it is loose, damaged or missing.
- If the reservoir does not lock into the pump or the retainer ring is loose, damaged or missing, immediately discontinue using the insulin pump and revert to a back-up plan per your healthcare provider’s recommendations. DO NOT insert the reservoir back into your pump while connected because you could mistakenly give yourself a rapid and possibly large, insulin bolus.
- If your reservoir properly locks in place with the retainer ring and the retainer ring is not loose, damaged, or broken, you may continue to use your pump until you receive your replacement pump. Follow the replacement instructions below.
- Remember to always follow the Instructions for Use on how to correctly insert the reservoir and examine your retainer ring for damage every time you change your infusion set. The black retainer ring in newer MiniMed™ 600 series insulin pumps is designed to improve durability. However, you should check your pump and retainer ring for damage every time you replace the insulin reservoir, or any time it is dropped or bumped.
If you have a pump with clear retainer ring, request a replacement insulin pump in one of two ways:
- Complete the form online by clicking on the button below or visit info.medtronicdiabetes.com/RetainerRing_Form
- Or call Medtronic 24-Hour Technical Support at 1-877-585-0166
Users can visit https://www.medtronicdiabetes.com/retainer-ring-serial-number-look-up/ and enter the serial number of the pump to confirm that the pump has a clear retainr ring.
IMPORTANT:Your replacement pump arrives without settings and requires transferring the current settings on your clear retainer ring pump to the black retainer ring pump prior to its use.
Before sending back your device, copy your current settings onto the Insulin Pump Settings Guide which you can find in the links below.
FREQUENTLY ASKED QUESTIONS
No, this is not a new issue. We initially notified our customers about this issue in November 2019.
Yes, this is a recall. We are asking our customers to return their MiniMed™ 600 series insulin pump that has a clear retainer ring.
Since the initial recall in November 2019, we have continued to carefully review reports of clear retainer ring damage. Based on this, we have updated the recall to replace all MiniMed™ 600 series insulin pumps that have clear retainer rings. The updated black retainer ring is designed to better withstand damage sustained by an accidental drop or bump on a hard surface. We closely monitor the quality of all our products and remain committed to providing safe medical technologies because nothing is more important than your safety and well-being.
Yes. Because we are expecting a high volume of calls and longer wait times, we created a simple online form for you to select your option to receive a replacement pump. If you are unable to complete the form online, you may also call us at 1-877-585-0166.
This recall only affects all MiniMed™ 600 series insulin pumps with the clear retainer ring. Insulin pumps with the updated black retainer ring design are not impacted by this recall.
No, this recall does not impact the MiniMed™ 700 series insulin pumps. All MiniMed™ 700 series insulin pumps include an updated retainer ring design.
No, this recall does not impact the MiniMed™ Paradigm™ insulin pumps or the MiniMed™ 530G system.
The MiniMed™ 600 series insulin pump with a clear retainer ring are eligible for replacement as part of the recall. The model numbers can be found on the bottom or on the back of your device. Please refer to the ACTIONS REQUIRED section outlined in your Urgent Recall Notice, or view instructions above on how to identify if your pump is affected by this issue. If you want to confirm that your pump has a clear retainer ring, please visit www.medtronicdiabetes.com/retainer-ring-serial-number-look-up and enter the serial number of your pump to check.
If you are still uncertain if your pump is impacted, contact the Medtronic 24-Hour Technical Support line at 1-877-585-0166 to troubleshoot the device and to discuss this issue in further detail to determine if your device is impacted.
Yes. Click here or contact Medtronic 24-Hour Technical Support line at 1-877-585-0166 to begin the replacement process.
If the reservoir does not lock into the pump or the retainer ring is loose, damaged or missing, discontinue using the insulin pump and revert to a back-up plan per your doctor’s recommendations. DO NOT insert the reservoir back into your pump while connected because you could mistakenly give yourself a rapid insulin bolus. You should immediately contact the Medtronic 24-Hour Technical Support line at 1-877-585-0166 or complete the online replacement request form.
Examine the retainer ring on your pump to determine if you have a clear retainer ring and whether it is loose, damaged or missing. If the reservoir does not lock into the pump or the retainer ring is loose, damaged or missing, discontinue using the insulin pump and revert to a back-up plan per your doctor’s recommendations. DO NOT insert the reservoir back into your pump while connected because you could mistakenly give yourself a rapid insulin bolus. You should immediately contact the Medtronic 24-Hour Technical Support line at 1-877-585-0166 or complete the online replacement request form.
If you determine your pump has a clear retainer ring, we recommend replacing your pump with the updated pump that has black retainer ring design. There is no charge for the replacement, and it will be provided even if the clear retainer ring is not damaged and regardless of the warranty status of the pump.
Yes. Click here to request a replacement pump at no charge. If you are unable to complete the form online, you may also call us at 1-877-585-0166. Please note that there may be longer than usual wait times due to high volume of calls.
Yes. Click here to request a replacement pump at no charge. If you are unable to complete the form online, you may also call us at 1-877-585-0166. Please note that there may be longer than usual wait times due to high volume of calls.
We’re always looking to continuously improve the quality of our products. The updated black retainer ring is designed to better withstand damage sustained by an accidental drop or bump on a hard surface. There is no change to the functionality of your pump and the retainer ring is now the same color of your pump.
If you determine your MiniMed™ 600 series insulin pump has a clear retainer ring, we recommend replacing your pump with an equivalent pump that has updated black retainer ring design. We will replace your pump at no charge, and it will be provided even if the clear retainer ring is not damaged and regardless of the warranty status of the pump..
Click here to begin the replacement process. If you are unable to complete the form online, you may also call us at 1-877-585-0166. Please note that there may be longer than usual wait times due to high volume of calls.
Yes. We will replace your pump regardless of the warranty status of the pump. Click here to begin the replacement process. If you are unable to complete the form online, you may also call us at 1-877-585-0166. Please note that there may be longer than usual wait times due to high volume of calls.