Maquet Cardiovascular Recalls Custom Tubing Sets for Extracorporeal Circulation
Maquet Cardiovascular is recalling custom tubing sets for extracorporeal circulation because a design flaw may prevent sterilization gas from reaching all parts of the device.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, and the failure to assure sterility in a device used for extracorporeal circulation poses a significant risk of serious injury or infection, meeting the criteria for a Severe rating.
Plain-English summary
Maquet Cardiovascular, LLC is recalling Custom Tubing Sets for Extracorporeal Circulation (ECC). The recall involves specific batch numbers: 3000045166, 3000050578, and 3000054620. The product is identified by the material code 701050647R01 and was distributed nationwide.
The recall was initiated because the closed stopcock and non-vented cap configuration may prevent the flow of humidity and ethylene oxide gas into the fluid path between the closed port and the cap. This issue means that the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured, potentially compromising the sterility of the device.
Healthcare facilities and consumers who have these specific tubing sets should stop using them immediately. Users should contact Maquet Cardiovascular, LLC for further instructions on how to return or dispose of the affected products.
The recalled product
- Product
- Maquet Getinge-BO-TOP 15200 OR PACK HMO & RF Material:701050647R01
- Manufacturer
- Maquet Cardiovascular, LLC
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 (1)
- Batch Numbers: 3000045166 3000050578 3000054620
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 183 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 183 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 failure
See all →- SevereAvKare Carboxymethylcellulose Sodium Eye Drops Recalled for Sterility Concerns
FDA (Drugs) · 2026-09-30
- SevereAvKare Carboxymethylcellulose Sodium Eye Drops Recalled for Sterility Concerns
FDA (Drugs) · 2026-09-30
- SevereROHTO DIGI-EYE Eye Drops Recalled Over Sterility Assurance Gap
FDA (Drugs) · 2026-07-29
- HighROHTO DRY-AID Eye Drops Recalled Due to Sterility Concerns
FDA (Drugs) · 2026-07-29
- SevereOne-Piece Introducer Tray kits recalled for sterility failure
FDA (Devices) · 2026-07-22
Similar recalls
- HighMaquet Custom Tubing Packs Recalled for Potential Endotoxin Exposure
FDA (Devices) · 2016-04-20
- HighDatascope Recalls Maquet Cardiopulmonary Bypass Tubing Kits Due to Valve Defect
FDA (Devices) · 2018-06-20
- HighDatascope Recalls Maquet Cardiopulmonary Bypass Custom Tubing Kits
FDA (Devices) · 2018-06-20
- HighMaquet Rotaflow Centrifugal Pump Tubing Recalled for Endotoxin Risk
FDA (Devices) · 2016-04-20
- HighMaquet CARDIOHELP System extracorporeal support device components recalled for sterility
FDA (Devices) · 2023-03-08
- HighMaquet Recalls HLS Set Advanced Oxygenator Tubing Packs Due to Endotoxin Risk
FDA (Devices) · 2016-04-20