Recall Z-0132-2015 ยท MWS Stabilizer, Heart
Maquet Cardiovascular, LLC
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.
| Date | Oct 24, 2014 (initiated Aug 13, 2014) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Package design/selection |
| Action | Maquet Inc. issued Recall letters/Acknowledgement forms dated via Fed-Ex on 8/13/2014. |
| Quantity | 16,532 units (19,270 units international) |
| Distribution | Worldwide Distribution: US (nationwide) and countries of: ARGENTINA, AUSTRIA, BANGLADESH, BELARUS, BRAZIL, BRUNEI, CANADA, CHILE, CHINA, COLOMBIA, CROATIA, CZECH REPUBLIC, DENMARK, ECUADOR, GERMANY, FINLAND, FRANCE, GREECE, HONG KONG, INDICA, INDONESIA, ISRAEL, ITALY, JAPAN, MEXICO, MALAYSIA, NETHER |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.