Maquet Cardiovascular Recalls Acrobat-i Positioners Due to Sterility Concerns
Maquet Cardiovascular is recalling 14,338 Acrobat-i Positioners because manufacturing deviations compromised the sterile barrier, meaning sterility cannot be assured during the product's 2-year shelf life.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (sterility compromise) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Maquet Cardiovascular, LLC is recalling 14,338 units of the Acrobat-i Positioner, Model Number C-XP-5000Z. The recall is due to deviations in the manufacturing process that created a compromise in the sterile barrier. As a result, the sterility of the devices cannot be assured during the duration of the product's 2-year shelf life.
The affected devices were distributed nationwide and internationally to numerous countries, including Albania, Algeria, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bosnia and Herzegovina, Brunei, Canada, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, India, Indonesia, Italy, Japan, Lebanon, Luxembourg, Malaysia, Netherlands, Oman, Pakistan, Poland, Portugal, Slovenia, South Africa, Spain, Switzerland, the Republic of Korea, Turkey, United Arab Emirates, and the United Kingdom. The recall covers specific batch numbers, including 3000272452, 3000289270, and 3000293675, among others.
Healthcare providers and facilities should stop using the affected Acrobat-i Positioners and contact Maquet Cardiovascular for instructions on how to return or dispose of the devices. Patients who have used these devices should consult their healthcare provider if they have concerns about potential sterility issues.
The recalled product
- Product
- Acrobat-i Positioner. Model Number C-XP-5000Z
- Manufacturer
- Maquet Cardiovascular, LLC
- Hazard
- Affected units
- 14,338
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 3000289270
- 3000293675
- 3000340401
- 3000382289
- 3000282355
- 3000287205
- 3000290368
- 3000306921
- 3000308238
- 3000307458
- 3000318694
- 3000282741
- 3000290350
- 3000306394
- 3000334128
- 3000355318
- 3000362345
- 3000278266
- 3000343467
- 3000353846
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Maquet Cardiovascular, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
Same manufacturer · Maquet Cardiovascular, LLC
See all →- HighVasoview Hemopro 2 Endoscopic Vessel Harvesting System Recall
FDA (Devices) · 2026-07-22
- HighVessel harvesting systems recalled after out-of-box failures in harvesting tool jaws
FDA (Devices) · 2025-10-01
- HighHeartstring III seal systems recalled over failures to load, deploy and seal
FDA (Devices) · 2025-09-24
- HighHeartstring III 4.3 mm seal systems recalled over loading and deployment failures
FDA (Devices) · 2025-09-24
- HighHeartstring III 3.8 mm seal systems recalled over three identified failure modes
FDA (Devices) · 2025-09-24
Same hazard · sterility compromise
See all →- SevereSpectra Medical Devices Recalls Sodium Chloride Injection Ampules Due to Sterility Concerns
FDA (Devices) · 2026-08-19
- HighStryker Recalls Ahto Dual Spike Tube Set Due to Leaking Handpiece
FDA (Devices) · 2026-08-12
- HighIntramedullary Bone Saw Blade Assembly Recalled Due to Potential Sterile Barrier Damage
FDA (Devices) · 2026-08-12
- ModerateIntramedullary Bone Saw Blade Assembly Recalled Due to Potential Sterile Barrier Damage
FDA (Devices) · 2026-08-12
- HighIntramedullary Bone Saw Blade Assemblies Recalled Due to Potential Packaging Damage
FDA (Devices) · 2026-08-12