- Covidien (COV -1.5%) reports its Puritan Bennett 980 ventilator system has the CE mark designation.
- Normally, achieving CE mark status is routine, but this has not been the case with its ventilator product line. Last May, the FDA slapped the company with a Class I recall notice for the battery packs used with its Newport HT70's after the firm recalled them a month before due to performance problems that posed great risk to patients.
- Earlier this year, the FDA issued another Class I recall notice to the firm pertaining to a software problem in the Puritan Bennett 840 Series ventilators. The glitch would potentially generate a diagnostic code that would shut the device down and force patients to breathe on their own.
- The 980 series is also approved by sale in the U.S., Canada and Japan. Commercial rollout will begin in the next several months.