The U.S. Food and Drug Administration (FDA) said it is aware that Medtronic Plc (NYSE:MDT) has notified customers to remove certain Left Heart Vent Catheters from use and sale, citing safety concerns.
The catheter is used to vent the left heart during cardiopulmonary bypass procedures lasting up to six hours.
The agency classified the action as a Class I recall, its most serious category, indicating continued use could result in serious injury or death.
Also Read: Court Nixes Jury Award Over Medtronic’s Heart Valve Infringement Claim
Device Defect And Potential Patient Risks
According to Medtronic, the affected catheters may fail to hold their shape when bent, despite being designed to remain malleable and retain shaft positioning.
If the defect is identified before use, procedures may be delayed while a replacement cannula is obtained. If not identified and the device is used, it may cause tissue abrasion or perforation. Perforation of critical heart tissue could be fatal if complicated, undetected, or untreated.
As of July 28, Medtronic reported three serious injuries and no deaths linked to the issue.
Separate Recall Involving Capsule Delivery Devices
In June, the FDA said it is aware that Medtronic and its subsidiary, Given Imaging Inc., have issued two letters to affected customers recommending that certain Bravo CF Capsule Delivery Devices be removed from where they are used and sold.
Medtronic stated that the capsule may not attach to the patient’s esophagus or detach from the delivery device as intended due to a misapplication of the adhesive during manufacturing Bravo CF capsule delivery device.
MDT Price Action: Medtronic shares were up 0.05% at $97.52 during premarket trading on Wednesday, according to Benzinga Pro data.
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