Tri-Staple 2.0 Black Intelligent Reload, Product Number SIG60AXT

FDA device recall Z-1228-2023 · posted 2023-03-06 · Open, Classified

Recall details

Recalling firm

Covidien, LP

Reason for recall

Affected lots have the potential for a broken sled vane, which may cause the reload to misfire leading to non-functional staple line closure, transecting tissue without forming staples, and tissue hang-up. These conditions may be associated to a delay to treatment, unspecified infection, hemorrhage/blood loss/bleeding, failure to anastomose, peritonitis, sepsis, pneumothorax, tissue trauma, or death.

Action taken

On January 25, 2023, the firm notified customers via Urgent Medical Device Recall letter. Customers were asked to take the following immediate actions: 1. Identify and quarantined all unused affected product. 2. Return unused affected product to Medtronic using the Customer Confirmation Form. 3. Forward the information to all who need to be aware within your organization, or to any organization where the affected product was transferred. There are no additional actions required for patients where a stapler in scope of this recall was used during a procedure. These patients should continue to be monitored in accordance with your medical facility s standard care protocols. If you have any questions regarding this communication, please contact your Medtronic Representative Customer Service at 800-962-9888, option 2.

Root cause

Process change control

Status

Open, Classified

Product code

GDW

Quantity affected

264 US; 5056 OUS

Distribution

Worldwide distribution - US Nationwide distribution in the states of Arkansas, California, Florida, Georgia, Louisiana, Massachusetts, New York, North Carolina, Ohio, Washington and the countries of A

Date initiated

2023-01-25

Date posted

2023-03-06

Location

North Haven, CT

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