Maquet Getinge-T 8030 High Flow Pigtail Tubing Recalled for Sterility Assurance Issues
Maquet Cardiovascular is recalling specific Custom Tubing Sets for Extracorporeal Circulation because a design configuration may prevent proper sterilization, potentially compromising sterility.
What this means for you
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, posing a risk of infection. This fits the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Maquet Cardiovascular, LLC is recalling specific units of the Maquet Getinge-T 8030 4 in High Flow Pigtail (Material: 709000366). These are Custom Tubing Sets used for Extracorporeal Circulation (ECC). The recall affects Batch Number 3000065493 and was distributed nationwide.
The recall was initiated because the closed stopcock/non-vented cap configuration of the tubing may prevent the flow of humidity and ethylene oxide gas into the fluid path during the sterilization process. This design issue means that the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured, creating a potential risk that the device may not be sterile when used.
Healthcare facilities and users of these specific tubing sets should stop using the affected units immediately. Users should contact Maquet Cardiovascular for instructions on how to return the product or obtain a replacement. No specific dates or additional distribution details are provided in the source text.
The recalled product
- Product
- Maquet Getinge-T 8030 4 in High Flow Pigtail Material: 709000366
- 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: 3000065493
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