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Tri-Staple 2.0 recallZ-1228-2023 · Covidien, LP · initiated Jan 25, 2023

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Covidien, LP or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Process change control

What the company is doing

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.

Recall details

Recall number
Z-1228-2023
Status
Open, Classified
Initiated by the company
Jan 25, 2023
Posted by the FDA
Mar 6, 2023
Recalling firm
Covidien, LP
Quantity
264 US; 5056 OUS
Product code
GDW
FDA submissions
K160176
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 Australia, Austria, Belgium, Canada, Canary Islands, Denmark, Finland, France, Germany, Ireland, Italy, Kuwait, Netherlands, New Caledonia, Norway, Poland, Portugal, Spain, Sweden, Switzerland, United Kingdom.

Product description

Tri-Staple 2.0 Black Intelligent Reload, Product Number SIG60AXT

Code information (models, lots, serial numbers)

UDI-DI (GTIN): 20884521543598 Lots: N2D0002Y, N2D0004Y, N2D0195Y

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

31 devices cleared under K160176 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

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