Reported Nov 5, 2014 · Terminated
Acrobat V Vacuum Off-Pump System OM-9100S Acrobat SUV Vacuum Off-Pump System OM-9000S Axius Xpose 3 Access Device…
Maquet Cardiovascular, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Maquet Cardiovascular, LLC · 45 Barbour Pond Dr · Wayne, NJ · 07470-2094
Is this the product you have?
- Acrobat V Vacuum Off-Pump System OM-9100S Acrobat SUV Vacuum Off-Pump System OM-9000S Axius Xpose 3 Access Device XP-3000 XPOSE 4 Access Device XP-4000 Acrobat V Vacuum Off-Pump System Each Acrobat V Vacuum Off-Pump system is intended for use during performance of cardiac surgical procedures through a sternotomy incision approach.
- Lot codes and dates
- class I 510 K exempt Acrobat V Vacuum Off-Pump SystemAcrobat SUV Vacuum Off-Pump System
OM-9100S250818322508362925084722250865152508772325089063250899422509068525091907250927832509296825093960250952072509664925097068250976792509789525098213
Axius Xpose 3 Access DeviceOM-9000S2508390425084006250844982508464825084928250850942508585025086057250863302508646825086786250868692508724925087330250874122508779325088394250887042508915425089224250897242509057825090748250909432509117125092128250922722509269025092813250931672509328125094024250940652509447325094712250948602509510725095600250957692509612825096305250964042509691325097097250973362509741725097747250978012509854025098968
XPOSE 4 Access DeviceXP-300025063171250632642506400525064805250652162506607225066261250672422506749325067915250688692507067125071619250724682507368425075060250770552507799925078510250788082508077325081495250829972508417925086061250874982508889625090502250908322509177925092248250928842509361925094030250957682509611825096687250975082509840225098904
62 of 62 codes
XP-40002506335125063594250641602506442825064917250653152506554725067036250673962506824525068555250691892506958925069971250704922507080825071242250720562507285225073562250744412507524925075644250766812507720825077638250781542507933425079975250802562508046525081324250815662508195925083287250836992508453325085038250855162508569625086333250865302508719225088336250885172508955725089623250903242509069225091410250918112509239825092567250930832509357025094620250948452509521125095862
- class I 510 K exempt Acrobat V Vacuum Off-Pump System
- Amount recalled
- 16,532 units (19,270 units international)
Where it was sold
- Nationwide
Why it was recalled
An internal finding identified the presence of pinholes/cuts in some of the Tyvek pouches of the vacuum tubing sets included as an accessory to Acrobat V Vacuum Off-Pump System, Acrobat SUV Vacuum Off-Pump System, Axius XPOSE 3 Access Device and XPOSE 4 Access Device.
This product could cause temporary or reversible health problems — stop using it.
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