Medtronic takes swift action in hemodialysis catheter recall to uphold patient safety

USA — In a bid to uphold patient safety, Medtronic’s recent recall of hemodialysis catheters has been classified as a Class I event by the U.S. Food and Drug Administration (FDA).

The recall, prompted by routine manufacturing testing, underscores the critical importance of preventing potential blockages that could impede catheter function and compromise patient outcomes.

Medtronic proactively reached out to healthcare providers in June, flagging an alarming discovery during routine manufacturing tests.

A potential blockage within the catheter came to light, which could lead to obstructed treatment and adverse effects, including blood clot formation and damage to red blood cells.

In response, healthcare providers utilizing the affected catheters are urged to promptly halt their use and place them under quarantine.

Encouragingly, Medtronic has not received any confirmed complaints or reports of adverse events or fatalities related to the identified issue.

Unraveling the recall details

The recall primarily pertains to specific lots of Mahurkar Acute Triple Lumen Catheters and Mahurkar Acute High-Pressure Triple Lumen Catheters.

It’s worth noting that Medtronic’s Mahurkar Elite Catheters remain unaffected by the recall, ensuring continued patient safety in their usage.

According to a company spokesperson, the recall decision stems from the potential ramifications of a blockage within the catheter’s central lumen.

This obstruction can disrupt treatment, limit flow, and even result in issues like hemolysis, embolism, or thrombosis.

The involvement of excessive MDX, a silicone-based lubricant coating the catheter tip, was identified as a key factor leading to these risks.

Collaborative efforts and lessons learned

Medtronic’s partnership with IQVIA’s Novasyte underscores the company’s unwavering dedication to patient well-being, with a proactive approach and transparent communication standing as a testament to their commitment.

This isn’t the first instance of Medtronic’s resolute actions in the face of potential risks, as evidenced by a prior incident that prompted the FDA’s issuance of a Class I recall notice.

The recent recall is not the first time Medtronic has demonstrated its resolve to address potential concerns.

An earlier episode spotlighted a hub defect in Mahurkar Acute Dual Lumen High Flow (13.5 French) Hemodialysis Catheters, which led to the FDA’s swift response in the form of a Class I recall notice in January.

Interestingly, this marks the third time that Medtronic has been involved in a recall related to Mahurkar hemodialysis catheters.

A recall in July 2022, carried out by the company’s subsidiary Covidien, involved more than 1 million Palindrome and Mahurkar hemodialysis catheters due to a hub defect that led to an unintended connection between extension catheters.

Subsequently, another recall was initiated in January of the same year due to reported potential catheter hub defects causing tube leaks.

Focused measures and recommendations

For those currently using catheters from the affected lots, a replacement procedure is recommended. Medical teams are advised to assess the patient’s overall risk profile and make informed decisions about the optimal timing for a catheter replacement.

Healthcare providers have a crucial role to play as well. Medtronic mandates a thorough inventory assessment to identify any affected products.

If found, the immediate steps are to quarantine and discontinue the use of all unused Mahurkar acute triple-lumen catheters and Mahurkar acute high-pressure triple-lumen catheters.

Medtronic is just the latest company in the last few months to be hit with a recall as it, anecdotally, seems FDA is letting go of any leeway given during the COVID-19 pandemic.

Since June, Teleflex, Ethicon, Draeger, Integra, Baxter, Abiomed, Philips, and Getinge – to name a few – have all been targets for recalls. Some have even seen more than one recall in the first half of 2023.

For all the latest healthcare industry news from Africa and the World, subscribe to our NEWSLETTER, and YouTube Channel, follow us on Twitter and LinkedIn, and like us on Facebook.