Medtronic's Field Action for 6-F Sherpa NX Delivery Catheter Classified by FDA as Class I Recall

October 9, 2019—Medtronic announced that the FDA has classified the company’s voluntary field action initiated in March 2019 related to the 6-F Sherpa NX Active coronary guide catheter as a Class I recall. The catheter is used during coronary and peripheral interventional procedures. This issue does not affect the Medtronic Launcher coronary guide catheter or other Medtronic coronary stents, balloons, or implantable devices.

Medtronic stated that, in response to receiving six complaints, the company conducted a thorough investigation of certain lots of the product and determined that the affected catheters may have the potential to lose outer material from a distal component that could result in the underlying stainless-steel braid wires being exposed after insertion.

The company advised that it has received no reports of patient injuries but, as a precaution, it has voluntarily recalled all models of the 6-F Sherpa NX Active catheters because of potential patient risks associated with this issue.

The issue was reported to the FDA and other regulatory authorities. Customers using the catheter have been asked to return all affected inventory to Medtronic. Additionally:

• Health care professionals can direct questions to their Medtronic Field Representative or Medtronic Customer Service at +1 (888) 283-7868. Patients may contact Medtronic Cardiovascular Patient Services at +1 (877) 526-7890, and may also view information about this action on the company's website here.
• Adverse reactions or quality problems experienced with the use of these products may be reported to the FDA online here (form available to fax or mail), or by phone FDA at +1 (800) 332-1088.