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.
- Product Name: Mahurkar Acute Dual Lumen High Flow (13.5 French) Hemodialysis Catheters (Mahurkar QPlus)
- Product Models: See Medical Device Recall Database entry
- Distribution Dates: March 19, 2022 to September 2, 2022
- Devices Recalled in the U.S.: 22,763
- Date Initiated by Firm: November 23, 2022
Mahurkar Acute Dual Lumen High Flow (13.5 French) Hemodialysis Catheters are implanted and used in hemodialysis (treatment to filter waste and water from the blood), apheresis (a technology that separates donated blood components to treat certain illnesses), and infusion (a method of putting fluids into the bloodstream) for up to 21 days.
Reason for Recall
Medtronic is recalling the Mahurkar Acute Dual Lumen High Flow (13.5 French) Hemodialysis Catheters due to a potential catheter hub defect that may cause leaks across the catheter’s tubes. During treatment, this leak could result in mixing of the arterial and venous blood, lead to increased recirculation and poor dialysis, or cause the development of blood clots in the blood vessels.
The use of the defective catheter may cause serious adverse health outcomes, including bleeding or the need for surgical removal and replacement of the affected catheter.
There have been two injuries reported related to this issue and no reports of death.
Who May be Affected
- People who receive care using the Mahurkar Acute Dual Lumen High Flow (13.5 French) Hemodialysis Catheters
- Health care personnel providing care using the Mahurkar Acute Dual Lumen High Flow (13.5 French) Hemodialysis Catheters
What to Do
On December 07, 2022, Medtronic sent customers an Urgent Medical Device Recall letter. The letter recommended the following actions:
For devices currently in use
- Continue to follow facility specific policies and procedures for routine assessment of the hemodialysis access device for patency, function, and efficacy.
- Clinicians should look for visible ‘communication’ or movement of catheter contents between the venous and arterial lumens within the catheter. It will not present as an external leak or defect.
- If the issue is detected, the patient’s medical team should use their clinical judgement in determining the necessity and timing of a replacement catheter in accordance to the product Instructions For Use and facility specific policies and procedures.
For all devices
- Visit Medtronic to access a tool to help determine if product is affected by this recall. Note: The affected devices are located within a kit, IC tray, or PASS tray.
- Immediately quarantine and discontinue use of all unused Mahurkar Acute Dual Lumen High Flow (13.5 French) Hemodialysis Catheters from affected lots.
- Complete the Customer Confirmation Form (even if affected product is no longer on hand) and email the completed form to:
- Recall Department firstname.lastname@example.org
- Customer Service email@example.com and request a Return Good Authorization (RGA) number.
- Return all unused affected Mahurkar Acute Dual Lumen High Flow (13.5 French) Hemodialysis Catheters to Medtronic per the company’s instructions with the RGA number received from Customer Service.
- Notify any recipients of distributed Mahurkar Acute Dual Lumen High Flow (13.5 French) Hemodialysis Catheters.
- Share this notice with the organization’s nephrologists, physicians, renal nurses, other dialysis or clinical staff who need to be aware.
Customers with questions about this recall should contact their Medtronic representative or call Customer Service at 800-962-9888, option 2.
- Medical Device Recall Database entry
- Covidien, LLC (Medtronic) Recalls Palindrome and Mahurkar Hemodialysis Catheters Due to Catheter Hub Defect
How do I report a problem?
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.