CoreValve Evolut PRO PLUS Delivery Catheter System recallZ-2043-2021 · Medtronic Heart Valves Division · initiated Jun 11, 2021

Why it was recalled

Due to reports of actuator separation for various delivery catheter systems. Affected products were manufactured before July 11, 2020.

FDA root cause category: Device Design

What the company is doing

On 06/09/2021, the Recalling Firm sent an "URGENT MEDICAL DEVICE RECALL" Notification via UPS 2-day (US Customers) and regionally approved methods (OUS Customer) to customers informing them that it has been identified that were is the potential for actuator separation with delivery catheter systems manufactured before 07/11/2020. Customer are instructed to: 1. Identify and quarantine all unused affected product manufactured before 11-JUL-2020.The enclosed Customer Notification Detail Report includes affected product for their facility. 2. Return all unused affected product in their inventory to Recalling Firm. Contact Customer Service at 800-854-3570 to initiate a product return. Their local Representative can assist them as necessary in initiating the return of this product. 3. Complete the enclosed Customer Confirmation Form and email it to [email protected]. 4. Forward this notice to all who need to be aware within their organization and to any organization where the affected product may have been transferred. For any questions or assistance, contact Customer Service at 800-854-3570

Recall details

Recall number

Z-2043-2021

Status

Open, Classified

Initiated by the company

Jun 11, 2021

Recalling firm

Medtronic Heart Valves Division

Quantity

Total of all Delivery Systems (Globally) = 67,339 units

Product code

NPT

Distribution

U.S.: AL, AK, AR, AZ, CA, CT, DE, DC, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NE, NH, NJ, NM, NV, NY, NC, ND, OH, OK, OR, PA, Puerto Rico, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV. O.U.S.: Albania, Argentina, Australia, Austria, Belarus, Belgium, Brazil, BULGARIA, Canada, Chile, CHINA, Colombia, COSTA RICA, Croatia, Curacao, CYPRUS, Czech Republic, Denmark, DOMINICAN REPUBLIC, Egypt, ESTONIA, FINLAND, FRANCE, FRENCH POLYNESIA, GEORGIA, Germany, Greece, GUATEMALA, HONDURAS, Hong Kong, Hungary, ICELAND, India, INDONESIA, IRAN (ISLAMIC REPUBLIC OF), Ireland, Israel, Italy, Japan, JORDAN, KAZAKHSTAN, KOREA, REPUBLIC OF, KUWAIT, LATVIA, LEBANON, LITHUANIA, Luxembourg, MACEDONIA (THE FORMER YUGOSLAV REPUBLIC OF), Malaysia, MALTA, Mexico, MOLDOVA (REPUBLIC OF), Montenegro, Netherlands, New Zealand, Norway, OMAN, Panama, Peru, Poland, Portugal, QATAR, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, SLOVAKIA (Slovak Republic), SLOVENIA, South Africa, Spain, Sweden, Switzerland, SYRIAN ARAB REPUBLIC, Taiwan (Republic of China), THAILAND, Turkey, UNITED ARAB EMIRATES, United Kingdom, URUGUAY, UZBEKISTAN, VENEZUELA and Viet Nam.

Product description

CoreValve Evolut PRO PLUS Delivery Catheter System, REF: D-EVPROP2329US; D-EVPROP34US;

Devices named in this recall

2 devices in the FDA device registry whose identifier appears in the recall's code information.

• Evolut™ PRO+ D-EVPROP2329US

  Medtronic Corevalve LLC · Aortic valve, prosthesis, percutaneously delivered
  1 recall40 deaths281 reports
• Evolut™ PRO+ D-EVPROP34US

  Medtronic Corevalve LLC · Aortic valve, prosthesis, percutaneously delivered
  1 recall9 deaths54 reports

Product lines

• Medtronic Evolut TAVRMedtronic Corevalve LLC · 45 models · 9,600 reports · 1 recall
• Evolut PRO+Medtronic Corevalve LLC · 8 models · 2,532 reports · 1 recall

Other products in the same recall event

The FDA groups related products into one recall event (event 88113).

• Z-2042-2021 · Open, Classified
  CoreValve Evolut PRO Delivery Catheter System, REF: ENVPRO-14; ENVPRO-16;