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Terminated

Retrograde Cardioplegia Cannula, Model Number RMG-0015S The Retrograde Cardioplegia Cannula is intended for use in perfusing cardioplegia solutions retrograde through the coronary sinus by means of transatrial introduction.

FDA Recall Z-0068-2019 · Posted None

Recalling FirmSurge Medical Sales, LLC (DBA Surge Cardiovascular)
Recall StatusTerminated
Product CodeDWF
Date Initiated2018-07-18
Date Terminated2019-04-04
Product Quantity35 units

Reason for Recall

The device was built with the rigid insertion stylet instead of the flexible stylet.

Firm Action

The firm, MediSurge, contacted its customer via email on 7/18/18. The email described the product, problem and actions to be taken. If you have any questions, contact Director of Quality Assurance/Regulatory Affairs, at 616-202-6120 or email: [email protected].

Root Cause

Nonconforming Material/Component

Distribution Pattern

US Distribution to state of: SC.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K964199CHASE CORONARY SINUS PERFUSION CANNULAChase Medical, Inc. · 1997-03-19

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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