June 2022

Attention: Risk Management Directors or Materials Management

Dear Valued Customer:

The purpose of this letter is to advise you that Medtronic has initiated a voluntary recall for specific lots of chronic hemodialysis catheters. You are receiving this letter as Medtronic records indicate your facility may have at least one of the chronic hemodialysis catheters identified for recall in Appendix 1. Medtronic initiated this action to prevent the usage of potentially affected chronic hemodialysis catheters that may impact patients.

Issue Description:

During the production process, Medtronic has identified a potential leaking condition within the hub of specific chronic hemodialysis catheters. Flushing one extension tube may result in unanticipated fluid return through the adjacent extension tube (in addition to the anticipated flow of fluid through the distal tip of the catheter). The condition is the result of an inter-lumen void formed in the hub component of the catheter during the manufacturing process. During use, this observed condition could translate to cross-communication of the blood circuit.

To date, Medtronic has received one reported complaint and has not received any reports of patient injury or death related to this issue.

Risk to Health:

Utilization of a product with this manufacturing defect could introduce the potential for patient harm(s) including embolism, thrombosis, hemolysis, infection, and inadequate treatment. Replacement of an implanted catheter could introduce the potential for patient harm(s) including infection, delay to treatment/ therapy, and unintended radiation exposure due to the placement of an additional catheter.

Patient Recommendation:

For patients with affected lots of chronic hemodialysis catheters currently in place, a replacement procedure may not be necessary. Clinicians should 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 interlumen communication of fluid, while flushing one extension tube, the clinician should 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.

Required Actions:

1. Immediately quarantine and discontinue use for specific lots of chronic hemodialysis catheters (see Appendix 1).
2. Return specific lots of chronic hemodialysis catheters as indicated in Appendix 1.
3. If you have distributed the specific lots of chronic hemodialysis catheters listed in Appendix 1, please promptly forward the information from this letter to those recipients.
4. Please complete the Recall Product Return form even if you do not have unused inventory.
5. Share this notice with those who need to be aware within your organization.
6. Retain this notification for your records regarding the retrieval of the unused product identified above.

Additional Information:

This action is being taken with the knowledge of the FDA and other regulatory authorities. We request that you contact Medtronic if you experience a quality problem or adverse event.

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.

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

Regular Mail or Fax: Download form: 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.

Sincerely,

Seth Kersten

Senior Director, Global Quality

Medtronic Renal Care Solutions