Medtronic EnVeo R Delivery Catheter System (DCS), Models: ENVEOR-L, ENVEOR-L-C, and ENVEOR-US. Designed to replace the n

FDA device recall Z-2546-2016 · posted 2016-08-16 · Terminated

Recall details

Recalling firm

Medtronic Cardiovascular Surgery-the Heart Valve Division

Reason for recall

Potential for vascular trauma with the use of the Medtronic EnVeo R Delivery Catheter System (DCS).

Action taken

Firm initiated a recall on 8/3/16 by sending an Urgent Medical Device Correction letter to inform them of the potential for vascular trauma with the use of the Medtronic EnVeo R Delivery Catheter System (DCS). The letter informs the customers of the recommendations to reduce the rate of vascular trauma events and the procedural uses. The letter informs the customers that the Evolut R System Instructions for Use (IFU) will also be updated appropriately consistent with the Dear Doctor communication. Patients with questions can contact Medtronic Cardiovascular Patient Services at 877-526-7890 (Monday-Friday, 7:30am-5pm Central Time). Customers with any questions are instructed to contact their Medtronic Field Representative or Lifeline Technical Services at 1-877-526-7890. On 8/19/16, firm sent a copy of a customer notification letter that will be sent to their customers to inform them that of the communication letter that was released in August 2016 by Medtronic regarding potential for aortic vascular trauma with the use of the Medtronic EnVeo R Delivery Catheter System (DCS). The letter informs the customers that FDA classify the recall as a Class II recall and the recall does not require customers to return the product. The recall letter informs the customers that Medtronic has taken further action by updating all customer training materials and the Instructions for Use (IFU).

Root cause

Device Design

Status

Terminated

Product code

NPT

Quantity affected

7,319 units

Distribution

Worldwide Distribution -- US, Australia, Austria, Belgium, Brazil, Colombia, Costa Rica, Czech Republic, Denmark, Dominican Republic, Egypt, Estonia, Finland, France, Germany, Greece, Hong Kong, Hunga

Date initiated

2016-08-03

Date posted

2016-08-16

Date terminated

2017-03-31

Location

Santa Ana, CA