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 proper sterilization, potentially compromising sterility.
What this means for you
Illness, injury, or structural failure has been reported. 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. Per the rubric, FDA Class II recalls are assigned a score of 4 (Severe), particularly when the defect involves a fundamental safety failure like sterilization assurance in a medical device.
Plain-English summary
Maquet Cardiovascular, LLC is recalling specific batches of Maquet Getinge-BEQ-T 46500 PRIME PACK custom tubing sets used for extracorporeal circulation. The recall is due to a potential sterilization failure where the closed stopcock and non-vented cap configuration may prevent humidity and ethylene oxide gas from reaching the fluid path. This issue means the Sterility Assurance Level (SAL) of the stopcock ports cannot be guaranteed.
The affected product is identified by Material 701065823 and includes Batch Numbers 3000043849 and 3000046392. The recall is classified as Class II by the FDA, indicating a situation where use of the product could, in most cases, cause temporary or medically reversible health consequences. The product was distributed nationwide.
Healthcare facilities and users should stop using the affected tubing sets and contact Maquet Cardiovascular for instructions on return or replacement. The recall is driven by the risk that the device may not be sterile, which is a critical safety requirement for devices used in extracorporeal circulation.
The recalled product
- Product
- Maquet Getinge-BEQ-T 46500 PRIME PACK Material:701065823
- 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: 3000043849 3000046392
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 →- 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
- SevereTransvenous Pacing Electrode Tray with Bipolar Balloon Pacing Electrode Recalled
FDA (Devices) · 2026-07-22
- SevereArterial Line Kit with Lidocaine HCL Injection Fails Sterility Testing
FDA (Devices) · 2026-07-22
- SevereOne-Piece Introducer Tray kits recalled for sterility failure
FDA (Devices) · 2026-07-22