Maquet Cardiopulmonary Gmbh recalls Percutaneous Insertion Kit (PIK)

The packaging may not consistently maintain sterile barrier integrity.

Percutaneous Insertion Kit (PIK), dilator set L, Model Numbers: 701054427 (USA), 701054427 (OUS);

On July 31, 2026 URGENT MEDICAL DEVICE REMOVAL letters were sent to customers. Customer Actions: 1. Ensure all affected, unused product in your inventory has been properly quarantined. 2. Please ensure this message is forwarded to any individuals that need notification within your organization or any organization where the affected devices have been transferred. 3. Contact Customer Service via email at customersupport.us@getinge.com or 888-943-8872, option 2 / (888 9GETUSA), Monday through Friday, between the hours of 8:00 a.m. and 5:00 p.m. (Eastern Time Zone) to return your unused, unexpired, affected product. Credit will be issued for returned product. 4. Complete and return the enclosed response form to Getinge by e-mailing a copy to recallresponses.qrc@getinge.com.

• FDA enforcement recordOfficial FDA database entry for Z-3146-2026
• FDA 510(k) clearance · K131666The device's official FDA premarket clearance record
• FDA device classification · DWFOfficial FDA classification for this device type
• CFR regulation · 21 CFR 870.4210The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Maquet Cardiopulmonary GmbhSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.