Terumo Cardiovascular Procedure Kits: Possible Blood Leaks in LeukoGuard Filters
Terumo recalls procedure kits with Pall LG6NS LeukoGuard arterial blood filters due to possible blood leaks. Affected kits may cause bleeding risks during heart surgery. Consumers should contact Terumo for details.
Use caution until it’s fixed
Possible blood leaks through the hydrophobic portion of the Pall LG6NS LeukoGuard Leukocyte Reduction Arterial Blood Filters.
Contact the company
What happened, in plain English
Terumo is recalling cardiovascular procedure kits that include Pall LG6NS LeukoGuard leukocyte reduction arterial blood filters because these filters might leak blood during use. This could lead to bleeding complications for patients undergoing heart surgery. Read more at govinfonow.com/recall/72299-terumo-cardiovascular-procedure-kits-possible-blood-leaks-in-leukoguard-filters.
Source Summary by GovInfoNow · govinfonow.com/recall/72299-terumo-cardiovascular-procedure-kits-possible-blood-leaks-in-leukoguard-filters · Updated August 31, 2026 · FDA enforcement record: FDA #Z-1314-2018
Cite this page
“Terumo Cardiovascular Procedure Kits: Possible Blood Leaks in LeukoGuard Filters.” GovInfoNow, updated August 31, 2026. https://govinfonow.com/recall/72299-terumo-cardiovascular-procedure-kits-possible-blood-leaks-in-leukoguard-filters. Based on FDA recall #Z-1314-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1314-2018%22&limit=1).
Why it’s dangerous
The Pall LG6NS LeukoGuard filters have a hydrophobic portion that may leak blood during use. This could cause bleeding complications in patients receiving heart surgery through cardiopulmonary bypass procedures.
Who’s affected
Patients undergoing heart surgery using the recalled procedure kits are most at risk. Medical professionals who use these kits for cardiopulmonary bypass procedures may also be affected.
How to tell if you have this one
Check if your kit includes the Pall LG6NS LeukoGuard leukocyte reduction arterial blood filter. The product is sold as a disposable kit for one-time use up to 6 hours.
- Brand
Terumo- Category
Medical device
What to do — step by step
Contact Terumo
Reach out to Terumo for specific instructions on whether your kit is affected and what to do next.
Where it went and when
Where it was distributed
Distributed in 7 states.
FDA distribution: “US Distribution to the states of : AL, OH, VA, NC, GA, NY, FL” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Alabama, Florida, Georgia, New York, North Carolina, Ohio, Virginia.
Recall timeline
FDA terminated this recall 16 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-1314-2018 (December 18, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1314-2018 to see it in context.
- Plain-language summary written by qwen3:4b on August 31, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.