Medtronic is once again in the crosshairs of an FDA Class I recall for its Mahurkar dialysis catheters. In the last two years, the company saw two Class I recalls for its hemodialysis catheters, first concerning 1 million devices, and then another 359,000, all of which had a risk of internal leaking and cross-contamination.
The latest recall pertains to Mahurkar Acute Triple Lumen catheters and Mahurkar Acute High Pressure Triple Lumen Catheters, which are indicated for hemodialysis and feature three tubes instead of the typical two. The additional port acts as a pathway ready for blood access or fluid and medication delivery between dialysis treatments. The catheters are intended for short-term use of up to 29 days.
“These catheters are available in straight extension and curved extension catheter options and kit, tray (IC Tray), and safety tray (PASS Tray) configurations,” according to Medtronic.
Of note, the recall does not include the Mahurkar Elite Catheters.
The recall relates to a newly identified issue, a reported occlusion in the tip of the catheter’s center lumen. The occlusion was found during manufacturing related testing and the company has reported no confirmed complaints, adverse events, or deaths.
After an investigation, Medtronic identified that the source of the occlusion was excessive MDX, “a silicone-based lubricant which coats the catheter tip,” according to the company recall notice. Excess MDX incorrectly applied to the catheters may result in partial or full occlusion, leading to a delay in treatment and reduced blood flow. Additionally, uncured or excessive MDX has the risk of dislodging from the catheter, resulting in hemolysis, embolism, or thrombosis.
The company recommends that patients with a recalled product implanted undergo a replacement procedure if overall health permits. Unused stock should also be immediately quarantined, and its use discontinued. Additionally, customers should contact Medtronic, or Novasyte — a IQVIA company assisting in the recall — to have affected product returned for processing.
“We regret any inconvenience this may cause,” Seth Kerten, senior director of global quality, Renal Care Solutions at Medtronic, wrote in the recall notice. “We are committed to patient safety and appreciate your prompt attention to this matter.”
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.