Capio Open Access Box 4 (Capio OPC); Model #M0068311251. Intended for use in general suturing applications during open o

FDA device recall Z-1619-2018 · posted 2018-05-04 · Terminated

Recall details

Recalling firm

Boston Scientific Corporation

Reason for recall

Potential for Capio sutures to break and /or detach.

Action taken

Boston Scientific sent Urgent Medical Device Correction letters, dated February 12, 2018, to customers via FED-EX two day delivery. Customers were informed of the updates to the affected product instructions for use and advised to read the notification carefully and immediately post the information in a visible location near the product to ensure it is easily accessible to all users of the device. Also, the notification should be passed on to any health professional of the customer's organization that needs to be aware and to any organization where the potentially affected devices have been transferred. Customers with questions should contact their local BSC (Boston Scientific) Representative. **No product is being recalled and you are not required to return product to Boston Scientific** There is no impact to previously implanted mesh devices.

Root cause

Device Design

Status

Terminated

Product code

PWI

Quantity affected

21,051

Distribution

Worldwide Distribution -- US, Brazil, Guatemala, Ecuador, Malaysia, Czech Republic, United Kingdom, Argentina, Honduras, Peru, Singapore, Denmark, Iceland, Chile, Nicaragua, Venezuela, Japan, Egypt, I

Date initiated

2018-02-12

Date posted

2018-05-04

Date terminated

2020-04-10

Location

Marlborough, MA