Z-0968-2012

XPOSE 4 Access Device (XP-4000) XPOSE 3 Access Device (XP-3000) positioners

Name: Z-0968-2012 XPOSE 4 Access Device (XP-4000) XPOSE 3 Access Device (XP-3000) positioners
Creator: Maquet Cardiovascular, LLC
Published: 2011-11-16
License: https://open.fda.gov/license/

Maquet Cardiovascular LLC / initiated 2011-11-16 / Terminated / root cause: manufacturing process

FDA source

Maquet Cardiovascular, LLC began a recall of 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... on 2011-11-16. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0968-2012
Status: Terminated
Initiated: 2011-11-16
Posted: 2012-02-06
Terminated: 2014-01-10
Recalling firm: Maquet Cardiovascular LLC
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.
Product code: MWS Stabilizer, Heart
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.
Root cause tag: manufacturing process
FDA root cause: 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
Product codes and lots: 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

Product code MWS

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)