Covidien Signia" Small Diameter Curved Tip Intelligent Reload, Model SIGSDS30CTVT

FDA device recall Z-1458-2024 · posted 2024-04-01 · Open, Classified

Recall details

Recalling firm

Covidien, LP

Reason for recall

Under certain firing conditions, reloads were found to articulate in an uncontrolled manner potentially causing disruption to the staple line. The issue is related to components in impacted reloads that are not fully secure, which leads to uncontrolled articulation. The issue can occur using either the Endo GIA" Ultra Universal Stapler or Signia" Stapling System.

Action taken

On February 14, 2024, the firm notified domestic customers and notified international customers starting February 19, 2024 of the issue via URGENT: MEDICAL DEVICE RECALL letters. Actions to be taken by the customer: 1. Identify and quarantine all unused impacted product listed above. 2. See Attachment A for guidance on identifying affected lots. 3. Return all quarantined devices to Medtronic. Please contact rs.covidienfeedbackcustomerservice@medtronic.com for the Return Goods Authorization (RGA). 4. Credit for the returned affected devices will be issued based on the RGA number. 5. If purchased from a distributor, contact your distributor directly to arrange for the return of the devices back to your distributor. 6. Please complete and return the enclosed Customer Confirmation Form to rs.gmbmitgfca@medtronic.com even if you do not have unused inventory. 7. Pass on this notice to all those who need to be aware within your organization or to any organization where the listed affected lots may have been transferred or distributed. Adverse events or quality problems experienced with this product should be reported to the FDA and Medtronic: Online at http://www.fda.gov/Safety/MedWatch/HowToReport/default.htm, or call FDA at 1-800-FDA-1088 (1-800-332-1088) and Medtronic Technical Services at 800-255-6774, option 2 to provide information regarding those events. We regret any inconvenience this may cause. We are committed to patient safety and appreciate your prompt attention to this matter. If you have any questions regarding this communication, please contact your Medtronic Field Representative or Customer Service at 800-962-9888 Option 2.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

GDW

Quantity affected

3,023 units

Distribution

Worldwide distribution - US Nationwide and the countries of France, Hong Kong, Israel and Japan.

Date initiated

2024-02-14

Date posted

2024-04-01

Location

North Haven, CT

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