December 2022

Dear Risk Manager/Healthcare Professional:

The purpose of this letter is to advise you that Medtronic is voluntarily initiating a recall for specific lots of the Mahurkar™* Acute Dual Lumen High Flow (13.5 French) Hemodialysis Catheters. This product is also known as the Mahurkar QPlus.

Please note: This recall does not include the Mahurkar™* Elite High-Flow (13.5 French) Catheters.

You are receiving this letter as Medtronic records indicate your facility may have at least one of the Mahurkar™* Acute Dual Lumen High Flow (13.5 French) Hemodialysis Catheters. Medtronic initiated this action to prevent the use of potentially affected product that may impact patients.

Issue Description:

During the production process, a potential internal leaking condition within the hub of specific Mahurkar™* Acute Dual Lumen High Flow (13.5 French) Hemodialysis Catheter was identified as a result of a void in the catheter hub. During dialysis, this observed adverse internal leaking condition could translate into cross communication of the blood circuit (see image below for defect location). Globally, there have been seven complaints as of October 14th, 2022, one of which has confirmed evidence of interlumen communication. There have been two reports of adverse events including one for thrombosis and one for insufficient flow. There are no deaths reported.

Risk to Health:

Utilization of a product with this manufacturing defect could introduce the potential for patient harm(s) including inadequate treatment, unintended radiation exposure, hemolysis, thrombus formation, embolism, delay to treatment, and potential infection.

Patient Recommendation:

For patients with affected lots of Mahurkar™* Acute Dual Lumen High Flow (13.5 French) Hemodialysis Catheters currently in place, a replacement procedure may not be necessary. Screening of catheters in production indicated that a majority of catheters (e.g., >99%) within the scope of the recall function as intended and do not exhibit the internal leaking condition within the catheter’s hub component. Clinicians should continue to follow facility specific policies and procedures for routine assessment of the hemodialysis access device for patency, function, and efficacy. If an interlumen void in the catheter hub is present, a ‘communication’ or movement of catheter contents between the venous and arterial lumens within the catheter may be visible; however, it would not present as an external leak or defect. If 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.

Additional Information:

This action is being taken with the knowledge of the FDA and other regulatory authorities. We request that you contact Medtronic Quality Experience Management if you experience a quality problem or adverse event by emailing rs.assurancequality@medtronic.com

Medtronic has partnered with Novasyte, an IQVIA company, to assist in this recall. For assistance regarding online response processing or product return for this recall, please contact Novasyte using the information below:

• Phone number: (855) 221-2646
• Email: medtronic-mahurkarqplus-fa-1295@iqvia.com

Adverse reactions or quality problems experienced with the use of the affected products may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.

• Complete and submit the report online: www.fda.gov/medwatch/report.htm
• Download form for regular mail or fax: www.fda.gov.medwatch/getforms.htm

We regret any inconvenience this may cause. We are committed to patient safety and appreciate your prompt attention to this matter. If you have any questions regarding this communication, please contact your Medtronic Representative or Customer Service at 800-962-9888, option 2.