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Manufacturing Error Leads To Class I Recall For Covidien Ventilator

 
• By Elizabeth Orr

The US FDA says a problem with how a capacitor was installed in the devices is why almost 300 devices are being recalled.

The screen of a Puritan Bennett 980 ventilator is seen in this file photo.
Medtronic

Medtronic plc subsidiary Covidien plc. is recalling some batches of the Puritan Bennett 980 series ventilator over a manufacturing error, a recent notice from the US Food and Drug Administration states. The agency classified it as a class I recall, which means it carries the highest risk for patients.

According to the FDA, a capacitor within the ventilator was put together incorrectly, which could cause the device to suddenly...

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CDX Medical Technologies Secures $2.5M To Advance Smart ECMO Platform Toward FDA Approval

 
• By Shubham Singh

CDX is eying applications for its pump platform that go beyond ECMO. The company’s CEO says smart pumps that can be fine-tuned to patient volume and configuration are needed, and CDX is creating a scalable solution capable of supporting both acute and chronic lung care.

Surgical Robotics CEOs Talk Metrics For Success, Valuations, Competition And IPO Outlook

 
• By Marion Webb

Leaders of robotic systems companies Distalmotion, Neocis and Noah Medical discussed success metrics, competition and funding. Institutional investors are focusing on utilization, procedure rates and a clear path to profitability as the IPO window reopens, BTIG analyst Ryan Zimmerman said.

A Year After Exiting The Ventilator Market, Medtronic Recalls Thousands Of Newport Devices

 
• By Brian Bossetta

After two serious injuries and one death linked to some of its ventilators, Medtronic has recalled the devices and asked customers to stop using them and find alternative means. The action comes more than a year after the company left the market.

Medtech Innovators Court London-Based Investors At BioWales 2025

 
• By Ashley Yeo

BioWales in London 2025 showcased the efforts healthtech innovators are making to meet investors on their own turf, illustrating changing attitudes and evolving needs.

More from Device Area

Medtech M&A Resurges: How To Define Startup Exit Strategy

 
• By Natasha Barrow

The medtech M&A landscape is experiencing a resurgence fueled by significant capital from private equity and venture firms, says Alex Wakefield, CRO of AcuityMD. Building strong relationships with physicians remains crucial in medtech, and defining an exit strategy early is imperative.

Intuitive Surgical Sees Early Wins With Da Vinci 5, Lifts FY25 Guidance As Tariff Impact Eases

 
• By Shubham Singh

For the full year, the company now expects tariffs to increase the cost of sales by approximately 1% of revenue, plus or minus 20 basis points. This is lower than the previous estimate of approximately 1.7% of revenue. The updated gross margin guidance for 2025 is 66%-67%, up from 65%-66.5%.

ForSight Sets Its Sights On Automating Delicate Eye Procedures

 
• By Marion Webb

ForSight Robotics is developing a robotic platform to automate cataract and other eye surgeries, aiming to ease surgeon strain and expand access. Backed by $200m in total funding, it's targeting a first human surgery using Oryom by year-end and is in discussions with US FDA.