—#106992

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.

FDA product code: MWS — Stabilizer, Heart
Device class: Class 1
Medical specialty: Cardiovascular
Affected lot / code info: 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

Why it was recalled

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.

Root cause (FDA determination)

Employee error

Action the firm took

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).

Recalling firm

Firm: Maquet Cardiovascular, LLC
Address: 45 Barbour Pond Dr, Wayne, New Jersey 07470-2094

Distribution

Distribution pattern: Worldwide Distribution - USA Nationwide

Timeline

Recall initiated: 2011-11-16
Posted by FDA: 2012-02-06
Terminated: 2014-01-10
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #106992. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.