FDA MedWatch - Palindrome and Mahurkar Hemodialysis Catheters by Covidien

Class I Recall - Due to Catheter Hub Defect

If your email program has trouble displaying this email, view as a webpage. MedWatch - The FDA Safety Information and Adverse Event Reporting Program TOPIC: Palindrome and Mahurkar Hemodialysis Catheters by Covidien: Class I Recall - Due to Catheter Hub Defect  AUDIENCE: Patient, Health Professional, Risk Manager, Nephrology, Urology ISSUE: Covidien (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. For more information about this recall, click on the red button "Read Recall" below. BACKGROUND: 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). RECOMMENDATIONS: On June 8, 2022, Covidien (Medtronic) sent an Urgent Medical Recall Letter to affected customers informing them of the product issue and potential risks to health.    Covidien (Medtronic) asked customers to take the following actions:  Immediately quarantine and discontinue use for specific lots of chronic hemodialysis catheters. Continue to follow facility specific policies and procedures for routine assessment of the hemodialysis access device for patency, function, and efficacy.  To identify the potential contamination of fluid, while flushing one extension tube, assess for the unanticipated simultaneous fluctuation of fluid in the adjacent extension tube.  If detected, the patient's medical team should use their clinical judgement in determining the necessity and timing of a replacement catheter. Return specific lots of chronic hemodialysis catheters as indicated. If you have distributed the specific lots of chronic hemodialysis catheters, please promptly forward the information from the letter to those recipients. Please complete the Consignee Product Retrieval Confirmation Form even if you do not have unused inventory. Share the notice with those who need to be aware within your organization. Retain the notification for your records regarding the retrieval of the unused product. Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program: Complete and submit the report online. Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178. Follow us on Twitter at @FDAMedWatch

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