Acrobat V Vacuum Off-Pump System OM-9100S Acrobat SUV Vacuum Off-Pump… — Class II medical device recall Z-0132-2015
Terminated recall by Maquet Cardiovascular, LLC, reported 2014-11-05, distributed nationwide. An internal finding identified the presence of pinholes/cuts in some of the Tyvek pouches of the vacuum tubing
| Recall number | Z-0132-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Maquet Cardiovascular, LLC, Wayne, NJ, United States |
| Recall initiated | 2014-08-13 |
| Classified | 2014-10-24 |
| Reported by FDA | 2014-11-05 |
| Terminated | 2016-03-30 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, BD, BR, CA, CH, CL, CN, CO, CZ, DE, DK, EC, ES, FI, FR, GB, GR, HK, HR, ID, IL, IT, JP, KR, MX, MY, NL, PA, PE, PH, PL, PT, RU, SA, SG, TR, TW, VN |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0132-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.