On January 20, 2023, the U.S. Food and Drug Administration (FDA) announced that Medtronic would recall more than 22,000 hemodialysis catheters. The Class I recall, the most severe type of product recall, of the Mahurkar Acute Dual Lumen High Flow (13.5 French) Hemodialysis Catheters followed reports of two injuries. Medtronic indicates that the Mahurkar family of dual lumen catheters is indicated for hemodialysis, apheresis and infusion.
Hemodialysis, a common treatment when kidneys are no longer able to clean blood, relies on catheters to filter waste and water from the blood. Hemodialysis helps control blood pressure and balance important minerals. During hemodialysis, a patient’s blood goes through a dialyzer, a large filtering machine sometimes called an “artificial kidney.” For some patients, a venous catheter is the best access method. A large, semi-flexible, hollow tube is implanted under the skin, usually by a nephrologist or interventional radiologist. The catheter, which can be used for three weeks, draws blood through one lumen (channel) and returns cleaned blood through another lumen, from the dialyzer to the body.
Catheters may also be used for therapeutic plasma exchange in the treatment of many diseases and indications. Appropriate vascular access, providing high blood flow for both phases of the procedure, is critical to the success of infusion or apheresis treatments. The Mahurkar catheter is used for the rapid withdrawal and return of blood necessary for apheresis.
The FDA’s announcement identified a possible defect in the recalled device’s hub, the end of the catheter that connects to the blood lines, that could result in leakages. Using a leaking catheter could cause severe adverse medical outcomes. A mixing of venous and arterial blood could leading to poor dialysis and recirculation, thrombi, and emboli.
The January 2023 recall follows the FDA’s August 2022 recall announcement of about 1,032,377 Medtronic hemodialysis catheters, marketed under the Palindrome and Mahurkar brands in the U.S. The manufacturing dates of the Palindrome and Mahurkar Hemodialysis Catheters recalled in August 2022 include June 1, 2017, through April 1, 2022. These products were distributed from June 28, 2017, until 11, 2022. and infusion procedures.
On June 8, 2022, Covidien, LLC, a Medtronic subsidiary, issued an Urgent Medical Recall Letter to impacted customers, telling them of the medical device’s issue and probable risks to health. At the time, Covidien, LLC urged customers to:
- Immediately discontinue the recalled chronic hemodialysis catheters.
- Immediately quarantine the recalled medical devices.
- Follow facility-specific procedures concerning hemodialysis patency, function, and efficacy.
- To identify fluid contamination by flushing one extension tube.
- If fluid contamination is discovered, the patient’s medical team must use their clinical judgment to determine the timing and necessity of a replacement catheter.
- Return recalled lots of chronic hemodialysis catheters.
- Forward the information from the recall letter to whom the products have been delivered.
- Complete the Consignee Product Retrieval Confirmation Form even when there aren’t any unused catheters.
- Share the recall notice with all medical professionals within your organization.
- Retain this notification for your records.
For any of the recalls, customers may contact Medtronic Technical Services at medtronic.com. A complete list of recalled devices can be found in the Medical Device Recalls database.
Medtronic Plc is a medical device technology company. Founded in 1949 and headquartered in Dublin, Ireland, Medtronic develops, manufactures, distributes and sells device-based medical therapies and services. Medtronic has announced plans to divest its dialysis business, forming a new firm with DaVita.
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