Medtronic Recalls Insulin Infusion Kits
May 19, 2004 -- A medical device maker is recalling an insulin
infusion kit used by people with diabetes due to potentially dangerous
Medtronic Inc. announced the nationwide recall yesterday after
reports of problems with their Quick-Set Plus infusion
models that can result in interrupted insulin flow to users. The company
says these problems have resulted in a number of serious injuries, including
This recall applies to all Paradigm Quick-Set Plus infusion set
models (MMT-359S6, MMT-359S9, MMT-359L6 and MMT-359L9) and lot numbers. It
affects only the Quick-Set Plus infusion set; no other Medtronic devices or
infusion sets are involved in this recall.
The infusion sets are used in conjunction with an insulin pump
and deliver insulin from the pump to a patient's body.
The company is asking patients to contact
its 24-hour help line at (800) MINIMED ((800) 646-4633) to exchange any unused
Quick-Set Plus infusion sets for replacement sets available from
Medtronic. If it is necessary to continue use of the Quick-Set Plus sets
while replacement sets are en route, Medtronic is recommending that patients
monitor their blood glucose levels frequently and be prepared to treat any
elevated glucose levels that may occur with insulin injections.
People who use the devices are also being
instructed to contact their healthcare professional in the event of excessively
high or low glucose levels or with any questions about their care. Information
regarding the exchange of Quick-Set Plus infusion sets is available at
Background on Recall of Insulin Infusion Kits
The voluntary recall is a follow-up to an
action undertaken by Medtronic in March 2004 in response to an increased number
of complaints related to the use of the Quick-Set Plus infusion set.
The complaints involved problems with
bending of the small tube or cannula used to infuse insulin into the body or
unintentional disconnection of the infusion set at the insertion site in the
At that time, customers were provided with
a Quick-Set Plus tips guide and offered replacement infusion sets upon request.
The company also discontinued selling the Quick-Set Plus infusion sets in
conjunction with this initial notification.
The FDA has classified the action as a
Class I recall. A Class I recall is a situation in which there is a reasonable
probability that the use of the product will cause serious adverse health
consequences or death.
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