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 Mahurkar™ Acute Triple Lumen Catheters and Mahurkar™ Acute High Pressure Triple Lumen Catheters.
Please note: This recall does not include the Mahurkar™ Elite Catheters.
You are receiving this letter as Medtronic records indicate your facility may have at least one of the Mahurkar™ Acute Triple Lumen Catheters and/or at least one of the Mahurkar™ Acute High Pressure Triple Lumen Catheters outlined in Attachment B. Medtronic initiated this action to prevent the use of potentially affected product that may impact patients.
Issue Description:
During manufacturing related testing, the catheter center lumen was found to have an occlusion in the tip of the catheter. Investigation identified the source of the occlusion as excessive MDX, a silicone-based lubricant which coats the catheter tip. As of 10 June 2023, there have been zero (0) confirmed complaints. Additionally, there have been zero (0) reported adverse events and there have been zero (0) reported deaths.
Risk to Health:
An incorrect application of MDX to catheters may result in the hazardous situation whereby the catheter is occluded, partially or fully, and/or uncured or excessive MDX may dislodge from the catheter. An occurrence of the hazardous situation may lead to potential harms identified as full catheter obstruction resulting in delay to treatment and partial obstruction resulting in reduced flow or particulate dislodgement that may result in delay to treatment, hemolysis, embolism/embolus or thrombosis/thrombus.
Patient Recommendation:
Mahurkar™ Acute Triple Lumen Catheters and Mahurkar™ Acute High Pressure Triple Lumen Catheters are intended for short term use of up to 29 days. For patients with affected lot(s) currently in place, a replacement procedure is recommended. If a patient is found to have a catheter from an affected lot, the patient’s medical team should assess the overall patient risk when considering the timing of a replacement. Clinicians should continue to follow current product Instructions For Use (IFU) along with facility specific policies and procedures for routine assessment of the hemodialysis access device for patency, function, and efficacy.
Required Actions:
- Determine if the product you have is affected by this recall. Jump to recall lookup tool
- Immediately quarantine and discontinue use of all unused Mahurkar™ Acute Triple Lumen Catheters and Mahurkar™ Acute High Pressure Triple Lumen Catheters. (See Identifying Affected Product for guidance to identify impacted product)
- Please note: This recall does not include the Mahurkar™ Elite Catheters.
- Complete the Customer Confirmation Form within 3 business days of receiving this notice. Replying promptly will confirm your receipt of the notification and prevent you from receiving repeat notices.
- Note: Please complete the online Customer Confirmation Form even if you DO NOT have affected product.
- If you have affected product, it must be returned for processing.
Upon completion of the online Customer Confirmation Form, Customer Service will contact you with an RGA number to return all unused affected Mahurkar™ Acute Triple Lumen Catheters and Mahurkar™ Acute High Pressure Triple Lumen Catheters from your inventory to Medtronic.
- This notice should be passed on to all those who need to be aware within your organization or to any organization including but not limited to Nephrologists, Intensivists, physicians, renal nurses, critical care nurses, ICU nurses or other dialysis staff where the potentially affected devices have been transferred. Please maintain a copy of this notice in your records.
Additional Information:
Medtronic is communicating this information to the US Food & Drug Administration (FDA).
Adverse reactions or quality problems experienced with this product should be reported to FDA and Medtronic:
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:
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
Renal Care Solutions
Identifying Affected Product
The MAHURKAR™* Triple Lumen Catheter is a radiopaque, polyurethane tube with two clear silicone catheter extensions and three internal lumina distinguished by color-coded adapters on the extensions:
- Red adapter (arterial)
- Blue adapter (venous)
- Clear adapter (medial)
The 12 Fr/Ch catheter is available in various implantable lengths as shown on the box and device labels. The MAHURKAR™* Triple Lumen Catheter is intended for short term central venous access for hemodialysis, apheresis, and infusion.
The MAHURKAR™* Triple Lumen Catheter is a radiopaque, polyurethane tube with two clear silicone catheter extensions and one clear polyurethane Infusion lumen. The three internal lumina can be distinguished by the color-coded luer-lock adapters on the silicone rubber extensions:
- Red adapter (arterial)
- Blue adapter (venous)
- Clear adapter (medial)
The proximal lumen provides "arterial" outflow from the patient; the distal lumen provides "venous" return; the medial lumen is for infusion of fluid, blood products, medications, blood sampling, pressure injection of contrast media and central venous pressure monitoring.
