FDA Class I Recall: Covidien, LLC (Medtronic) Palindrome and Mahurkar Hemodialysis Catheters
According to a release from the Food and Drug Administration (FDA), Covidien, LLC (Medtronic) has recalled its Palindrome and Mahurkar Hemodialysis Catheters due to a catheter hub defect.
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.
Recalled Product
Product Names: Palindrome and Mahurkar Hemodialysis Catheters
Product Codes: MSD
Model Numbers: See Recall Database Entries
Manufacturing Dates: June 1, 2017 to April 1, 2022
Distribution Dates: June 28, 2017 to May 11, 2022
Devices Recalled in the U.S.: 1,032,377
Date Initiated by Firm: June 8, 2022
Device Use
Palindrome and Mahurkar Hemodialysis Catheters
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).
Reason for Recall
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.
Who May be Affected
Healthcare providers using defective catheters.
Patients that have the defective catheter implanted.
What to Do
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:
· 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.
