Maquet Getinge ECC Pump Packs Recalled for Sterility Assurance Concerns
Maquet Cardiovascular is recalling specific ECC Pump Packs because a design feature may prevent proper sterilization, 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. The hazard involves a failure to assure sterility in a medical device used for extracorporeal circulation, which poses a significant risk of infection or serious injury, aligning with the 'Severe' criteria for significant injury reports or high-risk device defects.
Plain-English summary
Maquet Cardiovascular, LLC is recalling Maquet Getinge-BEQ-TOP 30907 ECC Pump Packs (Material: 701065770) due to a potential sterility issue. The recall covers units with batch numbers 3000041328 and 3000041619, which were distributed nationwide.
The recall was initiated because the closed stopcock and non-vented cap configuration on the custom tubing sets 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, meaning the devices may not be sterile.
Healthcare facilities and users should stop using the affected pump packs immediately. Maquet Cardiovascular is the recalling firm and is responsible for managing the recall process.
The recalled product
- Product
- Maquet Getinge-BEQ-TOP 30907 ECC PUMP PACK Material: 701065770
- 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: 3000041328 3000041619
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 CARDIOHELP System extracorporeal support device components recalled for sterility
FDA (Devices) · 2023-03-08
- HighMaquet Rotaflow Centrifugal Pump Tubing Recalled for Endotoxin Risk
FDA (Devices) · 2016-04-20
- HighRotaFlow Centrifugal Pump Seal Defect Poses Infection Risk
FDA (Devices) · 2024-02-14
- HighMaquet Custom Tubing Packs Recalled for Potential Endotoxin Exposure
FDA (Devices) · 2016-04-20
- HighGetinge Pediatric Diffusion Membrane Oxygenator Recalled for Sterility Concerns
FDA (Devices) · 2019-12-18
- HighMaquet Cardiovascular Recalls HLS Set Advanced Due to Sterility Breach
FDA (Devices) · 2020-12-23