The Resolution II Clip, 155 cm size and 235 cm size, Boxes of 1, 10, and 20 clips consists of a pre-loaded, radiopaque s

FDA device recall Z-3056-2011 · posted 2011-08-22 · Terminated

Recall details

Recalling firm

Boston Scientific Corporation

Reason for recall

Boston Scientific has received reports where, following clip deployment, the alignment of the clip and delivery system does not allow for the withdrawal of the delivery system away from the clip, resulting in tissue trauma, increased bleeding and the clip being pulled off tissue as the delivery system is withdrawn.

Action taken

Boston Scientific sent an URGENT MEDICAL DEVICE RECALL letter dated August 12, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to forward the Medical Device Recall to their customers. Customers were instructed to: Immediately discontinue use of any affected product. Complete and return the Reply Verification Tracking Form by fax to 508-683-5578. Package and return any affected product to: Boston Scientific Corporation Distribution Center Attn: QA Returns 500 Commander Shea Blvd Quincy, MA 02171 For questions regarding this recall call 508-683-5578.

Root cause

Other

Status

Terminated

Product code

FHN

Quantity affected

14, 093 boxes of both 155 cm and 235 cm size clips

Distribution

Worldwide Distribution - including USA (nationwide)

Date initiated

2011-07-19

Date posted

2011-08-22

Date terminated

2012-06-22

Location

Marlborough, MA

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