Tri-Staple 2.0 recallZ-1891-2024 · Covidien, LP · initiated Apr 15, 2024
Open, Classified
Is my device affected?
- 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.
- 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.
- 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
Potential damage to the cartridge can result in poor staple formation and/or incomplete staple line, may cause a delay in surgery
FDA root cause category: Under Investigation by firm
What the company is doing
Medtronic issued Urgent Medical Device Recall letter on 4/15/24 via UPS 2-day. Letter states reason for recall, health risk and action to take: Customer Actions: " Immediately identify and quarantine all unused Tri-Staple" 2.0 Black Reinforced Intelligent Reload, Model SIGTRSB60AXT, from the specified lot(s) mentioned above. " Return all unused product in your inventory, corresponding to the specified lot(s) mentioned above, to Medtronic as indicated in the enclosed Customer Confirmation Form. Please complete the enclosed Customer Confirmation Form, even if you have no product to return. Pass on this information to all those who need to be aware within your organization or to any organization where the potentially affected devices have been transferred. Please keep a copy of this letter in your file. 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-1891-2024
- Status
- Open, Classified
- Initiated by the company
- Apr 15, 2024
- Posted by the FDA
- May 24, 2024
- Recalling firm
- Covidien, LP
- Quantity
- 1681 units
- Product code
- GDW
- FDA submissions
- K173270
- Distribution
- Worldwide - US Nationwide distribution in the state of NJ and the countries of Australia, Japan, New Zealand, Saudi Arabia, Singapore, South Africa, Taiwan, Thailand.
Product description
Tri-Staple 2.0 Black Reinforced Intelligent Reload- Applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection of tissue and creation of anastomosis Model: SIGTRSB60AXT
Code information (models, lots, serial numbers)
GTIN: 10884521717633 20884521717630 Lot #: N3G1372Y
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Tri-Staple 2.0 SIGTRSB60AXTCovidien LP · STAPLE, IMPLANTABLE1 recall1 death615 reports
Product lines
Other devices under the same FDA submission
3 devices cleared under K173270 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Tri-Staple 2.0 SIGTRSB60AMTCovidien LP · STAPLE, IMPLANTABLE778 reports
- Tri-Staple 2.0 SIGTRSB45AXTCovidien LP · STAPLE, IMPLANTABLE107 reports
- Tri-Staple 2.0 SIGTRSB45AMTCovidien LP · STAPLE, IMPLANTABLE88 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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