Medtronic Recalls Sherpa NX Active Guide Catheters Due to Design Problem Leading to Unreasonable Risk of Death or Serious Injury
On March 15, 2019 Medtronic issued a safety recall for Sherpa NX Active Guide Catheters due to their propensity to fracture and migrate within the body. The FDA has reviewed the nature of the product problem and determined that use of these devices exposes patients to a reasonable probability of patient death.
What Is This Device: The device is used to assist with placement and exchange of guidewires and other intervention devices and to administer drugs or fluids into blood vessels. These devices are often used in percutaneous coronary interventions, also known as angioplasty, where stents or balloons are used to treat narrowed or stenotic sections of the coronary artery or heart.
Reasons for the Recall: Medtronic has admitted that the Sherpa NX Active Guide Catheters have an “unacceptable potential” for fracturing or fragmenting. These fractured pieces could be left inside the patient’s body, and this or the attempts to remove these fractured pieces, can cause dire health consequences such as blockage of blood vessels (occlusion), injury to blood vessel walls, development of blood clots, embolism, heart attack or death.
Who May Be Affected: Anyone having undergone a procedures using catheters such as procedures involving placement and exchange of guidewires and other intervention devices and to administer drugs or fluids into blood vessels. These devices are believed to have commonly been used in coronary angioplasty procedures.
Contact Brenes Law Group: Brenes Law Group has substantial experience litigating intravascular medical devices cases like these and has successfully litigated prior catheter failure cases. If you or a loved one underwent a medical procedure and were informed that a catheter or guidewire used during the procedure fractured, broke, migrated, or perforated a blood vessel wall, please contact Brenes Law Group for a free consultation.