BOX KIT00714 KIT SLEEVE Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two, triple-stagg

FDA device recall Z-1833-2018 · posted 2018-05-16 · Terminated

Recall details

Recalling firm

COVIDIEN MEDTRONIC

Reason for recall

Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents.

Action taken

On April 26, 2108, all consignees were issued were issued Urgent Medical Device Recall notices and Return Forms via Federal Express or certified mail. On May 22, 2018, all consignees received an UPDATED URGENT MEDICAL DEVICE RECALL notice. The updated notice included NEW product which has been processed under FDA Ref # 80423. The notice informs customers of the potential for use of a device with a missing sled and the actions they should take to discontinue use of the product and return all inventory of the affected lots to Medtronic (Covidien), 195 McDermott Road, North Haven, CT 06473, Attention: Field Returns Department. All in-control inventory and devices returned from customers will be reworked. **FOR INTERNATIONAL CUSTOMERS** Please be aware that the recalled units are packed within various convenience kits as identified on the Attachment B provided with your customer letter. Customers are also encouraged to EMAIL OR FAX THE ACKNOWLEDGEMENT FORM TO: - "Product purchased directly from Medtronic": feedback.customerservice@Covidien.com or fax to (800) 895-6140. - "Product purchased through distributor": FCAMITG@Covidien.com or fax it to (203) 492-7719.

Root cause

Process control

Status

Terminated

Product code

GDW

Quantity affected

171,271 units in total

Distribution

Worldwide and US Nationwide

Date initiated

2018-04-26

Date posted

2018-05-16

Date terminated

2020-06-17

Location

NORTH HAVEN, CT

Related 510(k) clearances