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European product recall

Medtronic recalls Covidien Endo GIA articulating loading units

Medtronic has received four reports of injury related to this issue

Medtronic has announced a voluntarily select recall for specific production lots of its Covidien Endo GIA™ Articulating Loading Unitn. The company said in a safety field notice that this voluntary recall is being conducted due to the potential for a device to be missing the sled component. The sled component is responsible for staple deployment and without the sled, no staples would be deployed. Use of a product with this issue may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents. Medtronic has received four reports of injury related to this issue.

This voluntary recall affects only the item codes and lots listed on Attachment A & B of the safety field notice (please click here to view the item codes)

Medtronic requests that users should immediately discontinue use of the affected products detailed on Attachment A and B, and that all such items should be quarantined and return any unused products of the listed item codes and lots. Unused products from the affected item codes and lots should be returned as described in safety field.

Furthermore, for distributors the company advises the to please promptly forward the information from this letter to recipients. All unused products from the – again affected item codes and lots must be returned.

“The Competent Authority of your country has been notified of this action. Please maintain a copy of this notice in your records. We request that you contact Medtronic if you experienced quality problems or adverse 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,” the company said in its statement.

To review the safety field notice, please click here

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