Medtronic notification classified as Class I recall
Device Regulation Alert: Safety, Compliance and Reimbursement News, October 6, 2008
The FDA considers Medtronic’s safety alert about the proper connection of sutureless catheters used with implantable drug infusion systems to be a Class I recall, a company release stated.
Medtronic notified the FDA and physicians in June 2008 that it had received 83 reports of improper alignment between the catheter’s connector and the pump’s port and disconnection of the catheter from the pump. The recall does not require devices be taken out or returned to Medtronic. Physicians do not need to take any action beyond those outlined in the June 2008 letter.
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