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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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.
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