CLASS II ONGOING Device recall · Reported 14 Feb 2024 · FDA Enforcement Report
Beq-rf-32-Usa RotaFlow Centrifugal Pump recalled
Maquet Medical Systems USA is recalling Beq-rf-32-Usa RotaFlow Centrifugal Pump with Bioline Coating, distributed nationwide in the US. The recall was initiated on 8 Jan 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0977-2024
- FDA event ID
- 93852
- Recalling firm
- Maquet Medical Systems USA, Wayne, NJ
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 8 Jan 2024
- FDA classified
- 2 Feb 2024
- Reported
- 14 Feb 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Heart & Vascular Devices
Timeline
| 8 Jan 2024 | Recall initiated by company | |
| 2 Feb 2024 | Classified by FDA | +25 days |
| 14 Feb 2024 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Nonconformities at their seal could potentially compromise the sterile barrier for affected products. Breach of sterile barrier could expose patients to pathogenic agents, resulting in the following potential harms: inflammation, infection, or sepsis.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
BEQ-RF-32-USA RotaFlow Centrifugal Pump with BIOLINE Coating, Product Code 701047554. For use with an extracorporeal cardiovascular or cardiopulmonary bypass circuit.
Where it was distributed
Worldwide - US Nationwide distribution to the states of CA, IL, MD, MO, NC, NY, OH, OR, PA, TX, UT, VA and the countries of Canada, Germany, Italy, Japan, and Netherlands.
Nationwide CaliforniaIllinoisMarylandMissouriNorth CarolinaNew YorkOhioOregonPennsylvaniaTexasUtahVirginia
Questions about this recall
Why was it recalled?
Nonconformities at their seal could potentially compromise the sterile barrier for affected products. Breach of sterile barrier could expose patients to pathogenic agents, resulting in the following potential harms: inflammation, infection, or sepsis.
Which lots are affected?
UDI-DI 4037691530864 Lots 3000286570 and 3000325568 ***Lots added 3/21/24*** 3000341070; 3000355577; 3000358977
Where was it sold?
Worldwide - US Nationwide distribution to the states of CA, IL, MD, MO, NC, NY, OH, OR, PA, TX, UT, VA and the countries of Canada, Germany, Italy, Japan, and Netherlands.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 93852This product is part of a recall event; the main page for the event is Bo-rf-32-Usa RotaFlow Centrifugal Pump recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Bo-rf-32-Usa RotaFlow Centrifugal Pump recalled | Maquet Medical Systems USA | Sterility | Nationwide |
More recalls from Maquet Medical Systems USA
All 41| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Cardiohelp-i System recalled by Maquet Medical Systems U | Maquet Medical Systems USA | Packaging Defects | Nationwide |
| Device | CLASS II | Model No. Beq-hls 5050 USA, HLS Set Advanced 5.0, Product Code/Part recalled | Maquet Medical Systems USA | Sterility | Nationwide |
| Device | CLASS II | Beq-hls 7050 USA, HLS Set Advanced 7.0, Product recalled | Maquet Medical Systems USA | Sterility | Nationwide |
| Device | CLASS II | Bo-rf-32-Usa RotaFlow Centrifugal Pump recalled | Maquet Medical Systems USA | Sterility | Nationwide |
| Device | CLASS II | Bubble Sensor recalled by Maquet Medical Systems U | Maquet Medical Systems USA | Device Malfunction | 13 states |
Other Heart & Vascular Devices recalls
All 6,199| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled | Atrium Medical | Potency & Assay | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes: *Bardex¿ I.C recalled | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Getinge PVC Thoracic Catheter, Firm PVC Straight recalled | Atrium Medical | Potency & Assay | Nationwide |