Maquet Getinge-T AV Manifold Recall Due to Sterility Assurance Concerns
Maquet Cardiovascular is recalling specific AV Manifold units for extracorporeal circulation because a design flaw may prevent proper sterilization of the stopcock ports.
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 medical device where sterility cannot be assured, creating a risk of harm from potential contamination. Per the rubric, risk-of-harm products where injury has not yet been reported are classified as High.
Plain-English summary
Maquet Cardiovascular, LLC is recalling the Maquet Getinge-T 41303 AV Manifold for Extracorporeal Circulation (ECC). The recall affects units with batch numbers 3000041542, 3000046483, 3000049065, 3000055328, 3000057682, 3000060483, and 3000063712. These products were 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 during sterilization. As a result, the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured, potentially compromising the sterility of the device.
Healthcare facilities and users should stop using the affected units and contact Maquet Cardiovascular for instructions on return or replacement. The source text does not report any specific illnesses or injuries associated with this recall.
The recalled product
- Product
- Maquet Getinge-T 41303 AV MANIFOLD FOR ECC PA Material:701066551
- Manufacturer
- Maquet Cardiovascular, LLC
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 compromise
See all →- ModerateAVID Medical Recalls Halyard IV Start Kits Due to Packaging Seal Issues
FDA (Devices) · 2026-09-30
- HighMedline Recalls Cataract Convenience Kits Due to Open Sterile Seals
FDA (Devices) · 2026-09-23
- HighMedline Myringotomy Kits Recalled for Potential Sterility Compromise
FDA (Devices) · 2026-09-23
- HighMedline Anesthesia Pain Kits Recalled for Potential Sterility Compromise
FDA (Devices) · 2026-09-23
- HighMaquet Percutaneous Insertion Kit Recalled for Sterile Barrier Integrity Issues
FDA (Devices) · 2026-09-23
Similar recalls
- HighMaquet CARDIOHELP System extracorporeal support device components recalled for sterility
FDA (Devices) · 2023-03-08
- HighMaquet Pediatric Arterial Cannula Recalled for Incorrectly Sized Connectors
FDA (Devices) · 2013-07-03
- HighMaquet Cardiovascular Recalls Acrobat-i Positioners Due to Sterility Concerns
FDA (Devices) · 2024-11-27
- HighMerit Medical Recalls Manifold Kits Due to Compromised Sterile Barrier
FDA (Devices) · 2016-11-30
- HighMaquet Cardiovascular Recalls HLS Set Advanced Due to Sterility Breach
FDA (Devices) · 2020-12-23
- HighAcrobat SUV Vacuum Stabilizer System Sterile Barrier Compromise Recall
FDA (Devices) · 2024-11-27