Boston Scientific Innova Over-the-Wire Self-Expanding Stent System, Catalog No. 39181-08023. 8 mm x 20 mm x 130 cm (sten

FDA device recall Z-2532-2011 · posted 2011-06-16 · Terminated

Recall details

Recalling firm

Boston Scientific Corporation

Reason for recall

Boston Scientific Corporation is conducting a recall of the Innova Self-Expanding Stent System because they have received 6 complaints involving no deployment/partial deployment of the Innova Stent. Potential health hazard events resulting from this type of failure include increased procedure time, vessel wall injury, and/or emergency surgery to remove the partially deployed stent. This recall d

Action taken

Boston Scientific sent an Urgent Medical Device Recall Removal - Immediate Action Required letter, dated May 13, 2011, to all affected customers via registered mail. The letter explained the issue, identified affected product, stated that further distribution and or use of the devices should cease immediately, and asked that devices in inventory to be segregated and immediately returned to Boston Scientific. An Account Reply Verification Tracking Form was also asked to be returned. Boston Scientific Sales Representative were assist in the return process by providing a Returned Goods Authorization (RGA) number. Customers were instructed to contact their local Sales Representative for any questions.

Root cause

Device Design

Status

Terminated

Product code

NIP

Distribution

Worldwide Distribution - USA (nationwide) and the countries of Product removal in US is being managed through SuperNOVA Clinical Trial suspension in accordance with IDE #G100291. OUS distribution to i

Date initiated

2011-05-19

Date posted

2011-06-16

Date terminated

2014-02-04

Location

Maple Grove, MN