Maquet Getinge-T 8028 Pressure Pigtail Recalled for Sterility Assurance Concerns
Maquet Cardiovascular is recalling specific Pressure Pigtail devices because a design feature may prevent sterilization gas from reaching all fluid paths, potentially compromising sterility.
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 hazard involves a potential failure of sterilization assurance for a medical device used in extracorporeal circulation, which carries a significant risk of serious injury or infection.
Plain-English summary
Maquet Cardiovascular, LLC is recalling the Maquet Getinge-T 8028 Pressure Pigtail 4" (Material: 701055993). The recall affects specific batch numbers: 3000054751, 3000055509, 3000061510, 3000066891, 3000075388, 3000080435, 3000080699, and 3000081533. The devices 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 between the closed port and the cap during sterilization. As a result, the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured, which poses a risk of infection if the device is used.
Healthcare facilities and consumers should check their inventory for the affected batch numbers. If the devices are found, they should be removed from use and returned to the manufacturer or the supplier in accordance with the recall instructions.
The recalled product
- Product
- Maquet Getinge-T 8028 PRESSURE PIGTAIL 4" Material: 701055993
- 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 · infection
See all →- SevereSafeguard US Operating LLC Recalls Compression Bandages Due to Degradation
FDA (Devices) · 2026-10-14
- SevereStryker Bard EP XT Decapolar Steerable Diagnostic EP Catheter Recalled for Sterile Barrier Breach
FDA (Devices) · 2026-10-14
- HighEmbosphere Microspheres Recalled Due to Packaging Sterility Concerns
FDA (Devices) · 2026-10-07
- SevereAurolab Trust Recalls FOCUS PI Eye Drops Due to Sterility Concerns
FDA (Drugs) · 2026-10-07
- HighFDA Recalls Performance Pro Nitrile Gloves Due to Defects
FDA (Devices) · 2026-10-07
Similar recalls
- HighMaquet Pediatric Arterial Cannula Recall for Limited Flexibility
FDA (Devices) · 2012-08-22
- HighGetinge Pediatric Diffusion Membrane Oxygenator Recalled for Sterility Concerns
FDA (Devices) · 2019-12-18
- HighMaquet Percutaneous Insertion Kit Recalled for Sterile Barrier Integrity Issues
FDA (Devices) · 2026-09-23
- HighMaquet Pediatric Arterial Cannula Recalled for Incorrectly Sized Connectors
FDA (Devices) · 2013-07-03
- HighMaquet Cardiovascular Recalls HLS Set Advanced Due to Sterility Breach
FDA (Devices) · 2020-12-23
- HighMaquet CARDIOHELP System extracorporeal support device components recalled for sterility
FDA (Devices) · 2023-03-08