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U.S. Department of Health and Human Services

Class 2 Device Recall XPOSE 4 Access Device (XP4000) XPOSE 3 Access Device (XP3000) positioners.

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  Class 2 Device Recall XPOSE 4 Access Device (XP4000) XPOSE 3 Access Device (XP3000) positioners. see related information
Date Initiated by Firm November 16, 2011
Date Posted February 06, 2012
Recall Status1 Terminated 3 on January 10, 2014
Recall Number Z-0968-2012
Recall Event ID 60987
Product Classification Stabilizer,heart - Product Code MWS
Product XPOSE 4 Access Device (XP-4000) XPOSE 3 Access Device (XP-3000) positioners.

Product Usage:
The OM-9100S Acrobat V Vacuum Off-Pump System is intended for use during performance of cardiac surgical procedures through a sternotomy incision. The stabilizer isolates and provides local immobilization of a vessel on the beating heart.
Code Information Pre-Market Notification Number: N/A, Class I Exempt Device Device Listing No. 0043888, 0033972  AXIUS XPOSE 3 Off Pump Positioner XP-3000   25037165, 25037244, 25038989, 25040320, 25040776   XPOSE 4 Off Pump Positioner XP-4000   25037059, 25037396, 25037447, 25037894, 25038001, 25038376, 25038550, 25038874, 25039267, 25039158, 25039455, 25039915, 25040060, 25040465, 25040617, 25040866, 25041058, 25041248, 25041714, 25041606, 25042076, 25042550   
Recalling Firm/
Manufacturer		 Maquet Cardiovascular, LLC
45 Barbour Pond Dr
Wayne NJ 07470-2094
For Additional Information Contact Ms. Karen LeFevere
973-709-7652
Manufacturer Reason
for Recall		 There may be a small perforation in the sterile pouch of select lots of the ACROBAT V, ACROBAT SUV, and ACROBAT Mechanical Stabilizers and the XPOSE 3 and XPOSE 4 Positioners.
FDA Determined
Cause 2		 Employee error
Action Maquet sent an Urgent Device Removal Immediate Action Required letter dated November 16, 2011 and a Field Action Response forms via Federal Express to to affected customers. The letter identifies the problem, product. risk factors and actions to be taken. Customers were instructed to examine their stocks immediately to determine if they have any of the recalled product. If so, discontinue dispensing (distributing) the lot and complete the Field Action Response form attached to complete and fax the attached Field Action Response form. In addition, it provides instructions for how to return the recalled product to MAQUET. Distributors are instructed to provide the same instructions to their customers supplied with the recalled products. If you have any questions contact the Recall Hotline Center at 1-888-613-0271. If you have any additional questions, contact your local MAQUET Cardiovascul'ar sales representative or Customer Service at 1-888-880-2874 (6AM -5PM PST).
Quantity in Commerce 9436 unit total (US AND WORLDWIDE)
Distribution Worldwide Distribution - USA Nationwide
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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