Acrobat V Vacuum Off-Pump System OM-9100S Acrobat SUV Vacuum Off-Pump System OM-9000S Axi...
FDA Device Recall #Z-0132-2015 — Class II — August 13, 2014
Recall Summary
| Recall Number | Z-0132-2015 |
| Classification | Class II — Moderate risk |
| Date Initiated | August 13, 2014 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Maquet Cardiovascular, LLC |
| Location | Wayne, NJ |
| Product Type | Devices |
| Quantity | 16,532 units (19,270 units international) |
Product Description
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.
Reason for Recall
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.
Distribution Pattern
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, NETHERLANDS, PANAMA, PERU, PHILIPPINES, POLAND, PORTUGAL, RUSSIA, SAUDI ARABIA, SINGAPORE, SLOVAK REPUBLIC, SOUTH KOREA, SPAIN, SWITZERLAND, TAIWAN, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM AND VIETNAM.
Lot / Code Information
class I 510 K exempt Acrobat V Vacuum Off-Pump System OM-9100S 25081832 25083629 25084722 25086515 25087723 25089063 25089942 25090685 25091907 25092783 25092968 25093960 25095207 25096649 25097068 25097679 25097895 25098213 Acrobat SUV Vacuum Off-Pump System OM-9000S 25083904 25084006 25084498 25084648 25084928 25085094 25085850 25086057 25086330 25086468 25086786 25086869 25087249 25087330 25087412 25087793 25088394 25088704 25089154 25089224 25089724 25090578 25090748 25090943 25091171 25092128 25092272 25092690 25092813 25093167 25093281 25094024 25094065 25094473 25094712 25094860 25095107 25095600 25095769 25096128 25096305 25096404 25096913 25097097 25097336 25097417 25097747 25097801 25098540 25098968 Axius Xpose 3 Access Device XP-3000 25063171 25063264 25064005 25064805 25065216 25066072 25066261 25067242 25067493 25067915 25068869 25070671 25071619 25072468 25073684 25075060 25077055 25077999 25078510 25078808 25080773 25081495 25082997 25084179 25086061 25087498 25088896 25090502 25090832 25091779 25092248 25092884 25093619 25094030 25095768 25096118 25096687 25097508 25098402 25098904 XPOSE 4 Access Device XP-4000 25063351 25063594 25064160 25064428 25064917 25065315 25065547 25067036 25067396 25068245 25068555 25069189 25069589 25069971 25070492 25070808 25071242 25072056 25072852 25073562 25074441 25075249 25075644 25076681 25077208 25077638 25078154 25079334 25079975 25080256 25080465 25081324 25081566 25081959 25083287 25083699 25084533 25085038 25085516 25085696 25086333 25086530 25087192 25088336 25088517 25089557 25089623 25090324 25090692 25091410 25091811 25092398 25092567 25093083 25093570 25094620 25094845 25095211 25095862 25097087 25097274
Other Recalls from Maquet Cardiovascular, LLC
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2586-2025 | Class II | Heartstring III Proximal Seal System. Intravas... | Aug 15, 2025 |
| Z-2588-2025 | Class II | Heartstring III Proximal Seal System, 4.3 MM. I... | Aug 15, 2025 |
| Z-2587-2025 | Class II | Heartstring III Proximal Seal System, 3.8 MM. I... | Aug 15, 2025 |
| Z-2636-2025 | Class II | Vasoview Hemopro 3 Endoscopic Vessel Harvesting... | Aug 6, 2025 |
| Z-1622-2025 | Class II | The VASOVIEW HEMOPRO 2 Endoscopic Vessel Harves... | Mar 20, 2025 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.