# China NMPA Product Recall - Laparoscopic disposable stapler with curved staple cartridge

Source: https://www.globalkeysolutions.net/records/china_product_recall/covidien-llc/e58a2714-74f9-49f1-8bf1-29f340bbf9f7/
Source feed: China

> China NMPA product recall for Laparoscopic disposable stapler with curved staple cartridge by Covidien llc published November 03, 2017. Recall level: Level 2 Recall. Medtronic, through its subsidiary Covidienllc, initiated a voluntary Class II recall of specific bat

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Covidienllc is proactively recalling its laparoscopic single-use stapler cartridge with curved attachment.
- Company Name: Covidien llc
- Publication Date: 2017-11-03
- Product Name: Laparoscopic disposable stapler with curved staple cartridge
- Recall Level: Level 2 Recall
- Recall Reason: Two complaints have been received globally regarding the device's staple cartridge becoming detached during use, a problem attributed to a manufacturing error. Using the device with this issue during surgery may result in the need to remove the dislodged object or incomplete staple formation leading to nonfunctional tissue anastomosis.
- Discovering Company: Covidien Medical Devices International Trading (Shanghai) Co., Ltd.
- Manufacturing Company: Covidien llc
- Summary: Medtronic, through its subsidiary Covidienllc, initiated a voluntary Class II recall of specific batches of its Arc-Shaped Staple Container for Disposable Endoscopic Cutting Stapler (Model EGIARADXT, Batch N6L0351X). This recall, reported to the National Medical Products Administration (NMPA) on September 29, 2017, and published on November 3, 2017, was prompted by two global complaints. The core issue involves the potential for the staple container to become loose during surgical use, attributed to a manufacturing error. Such detachment could necessitate the removal of foreign material or result in incomplete tissue anastomosis, compromising surgical outcomes. The recalled device, designed for various open and minimally invasive general, obstetrics and gynecology, and thoracic surgeries, is used to sever and anastomose tissues. While this issue has the potential for patient harm, Medtronic has not received any reports of patient injuries to date. Importantly, the affected products were not sold in China. Consequently, the Chinese regulatory authority, NMPA, has determined that no further corrective actions are required within China.

Company: https://www.globalkeysolutions.net/companies/covidien-llc/5111c5da-0a3d-4895-b59e-e49f0ad3547d/