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Terminated

MEGA 7.5Fr. 30cc Intra-Aortic Balloon Catheter with Insertion Kit & STATLOCK MEGA 7.5Fr. 40cc Intra-Aortic Balloon Catheter with Insertion Kit & STATLOCK MEGA 8Fr. 50cc Intra-Aortic Balloon Catheter with Insertion Kit & STATLOCK MEGA 8Fr. 50cc Intra-Aortic Balloon Catheter with Insertion Kit, STATLOCK & APA

FDA Recall Z-1935-2016 · Posted None

Recalling FirmDatascope Corporation
Recall StatusTerminated
Product CodeDSP
Date Initiated2016-05-13
Date Terminated2019-03-22
Product Quantity31,030 units (US); 15,604 units (OUS)

Reason for Recall

It was discovered during post-quarantine packaging on 2/16/2016 that the IFU for the STATLOCK Sheath Stabilization device for Percutaneous Sheath Introducer (Vendor PN 2403097-1405R) was erroneously packaged with the Mega and Sensation Plus IAB Catheter Kits instead of the IFU for the STATLOCK Catheter Stabilization device for IAB catheters (Vendor PN 24030905-1406R).

Firm Action

Maquet Inc sent an Urgent Medical Device Field Correction Letter/Response Form dated 5/13/2016 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers.

Root Cause

Unknown/Undetermined by firm

Distribution Pattern

Worldwide Distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K120868MEGA(TM) 7.5FR. 30CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES, MEGA(TM) 7.5FR. 40CC INTRA-AORTIC BALLOON CATHETERDatascope Corp., Cardiac Assist Division · 2012-04-20

Official Source

View FDA Recall →

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

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