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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.
The Palindrome and Mahurkar catheters are implanted and used in hemodialysis (treatment to filter waste and water from your blood), apheresis (a technology that separates donated blood components to treat certain illnesses), and infusion (a method of putting fluids into the bloodstream).
Covidien, LLC (Medtronic) is recalling the Palindrome and Mahurkar catheters due to a catheter hub defect that will connect both extension catheters. 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 returns unanticipated fluid 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, and the development of thrombi and emboli.
The use of the defective catheter may cause serious adverse health outcomes, including bleeding, surgical removal and replacement of the affected catheter.
There has been one complaint. There have been no reports of death or injury.
On June 8, 2022, Covidien, LLC (Medtronic) sent an Urgent Medical Recall Letter to affected customers informing them of the product issue and potential risks to health.
Covidien, LLC (Medtronic) asked customers to take the following actions:
Customers with questions about this recall should contact Medtronic Technical Services at 1-888-826-5603 or email at rs.navtechsupport@medtronic.com.
A complete list of affected devices is available in the Medical Device Recalls database.
Medical Device Recall Database Entries
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or FAX.
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