Cook Incorporated Upgrades Recall of Atrial Septal Puncture Needle to Class I Due to Risk of Thrombosis

On March 26, the National Medical Products Administration released information stating that Cook Medical has voluntarily recalled 100 atrial septal puncture needles (Registration Certificate No.: Guo Xie Zhu Jin 20143155640) with batch number 8833687, due to a potential defect involving the absence of the bevel on the needle tip. The recall level has been upgraded from Class II to Class I.

On February 19, Cook Medical issued a recall notice. The notice stated that, during an analysis of customer complaints, the company identified a complaint involving six returned atrial septal puncture needles (Model: TSNC-18-71.0) with a quality defect characterized by the absence of the bevel on the needle tip. This defect may cause damage to the interior of the introducer sheath device during interventional procedures. Cook Medical is voluntarily recalling atrial septal puncture needles with lot number 8833687. The recall is classified as Class II.

Atrial Septal Puncture Needle products are used in cardiac interventional procedures to establish left heart access via atrial septal puncture. A cardiologist specializing in interventional cardiology told reporters that during interventional treatments such as left-heart ablation performed through the atrial septum, if the needle tip of the atrial septal puncture needle lacks a bevel, it can cause increased damage to the atrial septum, potentially resulting in an atrial septal shunt and subsequent complications.

According to reporters, the reason for upgrading the product recall level is that when the company reported to the U.S. FDA for a product recall, the FDA analysis concluded that if the needle punctures and damages the internal structure of the introducer sheath during interventional therapy, it could cause fragments of the introducer sheath to fall into the blood vessel, damaging the vessel wall and potentially leading to thrombosis, posing significant potential harm to the human body. Therefore, the FDA required the recall level to be upgraded to Class I. Cook Medical subsequently also raised the recall level in China.

Regarding the defect of missing needle bevels on product needles, industry expert Wu Jun analyzed that the issue might stem from equipment malfunctions during production, which were not promptly detected by production control measures.

The company’s voluntary upgrade of the recall to a Class I recall means that the company must notify relevant medical device distributors, user institutions, or inform users within one day, and implement quality control for each individual product.

According to the company’s recall report, this recall involves 100 products that have been sold in the U.S. and Canadian markets; China has not yet imported the affected batches.

Original Title: Cook Medical Upgrades Recall of Atrial Septal Puncture Needle to Class I: May Cause Thrombosis