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Covidien, LLC (Medtronic) is recalling the Palindrome and Mahurkar catheters due to a catheter hub defect. There is a potential leaking condition within the hub of specific chronic dialysis catheters. This may be noticed when flushing one extension tube and the flow of fluid through the tip of the catheter unanticipated fluid returns through the adjacent extension tube. During treatment, this leak could result in mixing of the arterial and venous blood and lead to increased recirculation and poor dialysis. The use of the defective catheter may cause serious adverse health outcomes, including bleeding, surgical removal, and replacement of the affected catheter.
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
Questions?
If you have questions about this recall, contact Medtronic Technical Services at 1-888-826-5603 or email at rs.navtechsupport@medtronic.com.
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