FDA Device Recall Z-0099-2019

Maquet Datascope Corp - Cardiac Assist Division · Mahwah, NJ

Class I — life-threatening Ongoing

Highest impact — Class I device recall — FDA determination that use of, or exposure to, the device will cause serious adverse health consequences or death. Distribution is nationwide and the recall remains in progress.

Device

Cardiosave Hybrid IABP, Part Number 0998-00-0800-53

Lot / serial / GTIN: UDI - 10607567108391 All Serial Numbers

Quantity: N/A

Reason for recall

There is a potential for interruption and/or inability to start therapy to the patient prior to or during use of Cardiosave IABP for users who are at altitudes above 3200 Ft.

Recall record

Recall number: Z-0099-2019
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Press Release
Distribution: US Nationwide; Internationally to 77 countries
Recall initiated: 2018-09-20
Classified by FDA Center: 2018-10-26
FDA published: 2018-11-07
Recalling firm: Maquet Datascope Corp - Cardiac Assist Division
Firm location: Mahwah, NJ

Operational response

A Class I device recall indicates a strong likelihood of serious adverse health consequence or death from continued use. Identify affected units by serial number, lot, or GTIN against your inventory and against implanted-device patient registry. Pull affected inventory from active use immediately. For implanted devices, follow the recalling firm’s patient-notification protocol; in most cases this requires informing affected patients and their treating physicians directly.

For the official FDA enforcement record, see FDA's Recall Search.

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