Medtronic Issues Class I Recall in China for Cardioplegia Delivery Cannula Due to Potential Serious Risks

Source: Medical Device Business Review

Recently (July 31, 2025), the National Medical Products Administration released information regarding the Medtronic Cardioplegia Delivery Cannula.Recall Information,The recall is classified as the most severe level, indicating that the series of devices may cause serious injury or death.

It is worth mentioning that this recall is an update to the report submitted to the National Medical Products Administration on April 17, 2025, regarding the recall of 36 specific batches of antegrade perfusion catheters (Hu Drug Supervision Device Main Recall 2025-032).This recall adds a specific batch number (0230554221), model (11014L).The batch number imported has increased by 10 boxes, of which 3 boxes were sold to the Chinese market, and the remaining 7 boxes are locked in the Medtronic Shanghai warehouse.

The specific product information for this recall is as follows:

Recalled Product

• Product Name:Antegrade Perfusion Cannula Cardioplegia Delivery Cannula

• Number of products sold in China: 136 boxes

• China Medical Device Registration No. 20153101305

Equipment Overview

Used to deliver cardioplegia solution during cardiopulmonary bypass surgery.

Image source: Medtronic official website

Reason for Recall

During the manufacturing process, suspected scratches and loose plastic material were found in the male luer connector used for antegrade perfusion cannulation. As of July 14, 2025, Medtronic has not received any complaints related to this issue. If this problem is discovered before use, the potential hazard could be surgical delays.

If this issue is not identified before use and the catheter is used, the potential hazard is neurological dysfunction.

Medtronic China will send a Medical Device Voluntary Recall Notification Letter to all affected customers, explaining the background and requirements of this recall; at the same time, it will cease the operation and use of the affected products, return unused affected products, and submit the signed confirmation letter.

The product has been used by the customer, and no further action is required. The affected products will be uniformly quarantined in our company's warehouse after being returned, and will be returned to the original factory or destroyed according to the final disposal decision.

Attachment: Full list of affected devices (Click to read the original text for more information)