| Developers: | Medtronic |
| Branches: | Pharmaceuticals, Medicine, Healthcare |
2022: Recall of 1 million defective dialysis catheters
On July 11, 2022, it became known that Medtronic was recalling more than 1 million dialysis catheters due to a malfunction that could potentially lead to the leakage of devices during use.
FDA The company is recalling nine different kinds of dialysis catheters, which number about 1.02 million devices affected, according to the data. The recall, which began on June 8, 2022, concerns a subsidiary of Medtronic -. Covidien
Medtronic said in an emailed statement that "no patient harm has been reported so far and the product recall process is underway. An investigation into the cause of the incident is ongoing and Medtronic has notified all relevant regulatory authorities. "
The FDA classified the recall for each product as Class I, the agency's most serious classification, and combined all products into one recall.
The regulator indicated the same reason for the recall of each product: "potential leakage of fluid from the sleeve of special catheters for chronic dialysis due to an interluminal slit in the bushing component, which may lead to unexpected leakage of fluid during use."
Medtronic sent a recall notice to customers by mail on June 8, 2022, according to the FDA. The letter asked customers to "immediately quarantine and stop using" the relevant products and return them to Medtronic.
The company also requested that any adverse product-related events be reported to the FDA. The recall includes several models of Palindrome Chronic catheters and one model of Mahurkar Chronic Carbothane catheter.
This recall is the latest product safety issue facing Medtronic. Along with the latest recall, the FDA posted seven recall warnings for Class I products in 2022. In 2021, the agency posted 10 recall notices for Class I products.
CEO Jeff Marta gave a speech in January 2022 on ongoing reviews, calling them his top priority. However, the company has since repeatedly recalled Class I products, including further feedback from the HVAD pump, which has already been withdrawn from the market.[1]
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