FDA Devices recall · Reported April 18, 2018
Terumo Cardiovascular Procedure Kits containing Pall LG6NS LeukoGuard¿ Leukocyte Reduction Arterial Blood Filters. The Cardiovascular Procedure Kit containing the Pall LG6NS LeukoGuard¿ Leukocyte Reduction Arterial Blood Filter for Exh¿acorporeal Service is indicated for use only in the exh¿acorporeal circuit for cardiopulmonary bypass procedures for which the user designed it. The product is a sterile, disposable kit, intended for one time use for period up to 6 hours, after which it must be
Possible blood leaks through the hydrophobic portion of the Pall LG6NS LeukoGuard Leukocyte Reduction Arterial Blood Filters.
Terumo Cardiovascular Systems Corp recalled Terumo Cardiovascular Procedure Kits containing Pall LG6NS LeukoGuard¿ Leukocyte Reductio… - a moderate-severity action.
Terumo Cardiovascular Procedure Kits containing Pall LG6NS LeukoGuard¿ Leukocyte Reductio… was recalled by Terumo Cardiovascular Systems Corp in April 18, 2018. Reason: Possible blood leaks through the hydrophobic portion of the Pall LG6NS LeukoGuard Leukocyte Reduction Arteria…. Check the official notice for the remedy. Verify recall #Z-1314-2018 with the FDA Devices before acting.
The recall
Terumo Cardiovascular Systems Corp issued this moderate-severity FDA Devices recall-Possible blood leaks through the hydrophobic portion of the Pall LG6NS LeukoGuard Leukocyte Reduction Arteria….
- Moderate
- severity level
- 3K units
- affected scope
- Class II
- classification
- April 18, 2018
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1314-2018 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 41,021 medical devices recalls on record
Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Product description
Terumo Cardiovascular Procedure Kits containing Pall LG6NS LeukoGuard¿ Leukocyte Reduction Arterial Blood Filters. The Cardiovascular Procedure Kit containing the Pall LG6NS LeukoGuard¿ Leukocyte Reduction Arterial Blood Filter for Exh¿acorporeal Service is indicated for use only in the exh¿acorporeal circuit for cardiopulmonary bypass procedures for which the user designed it. The product is a sterile, disposable kit, intended for one time use for period up to 6 hours, after which it must be discarded in a manner which is within acceptable laws and practices. The Pall LG6NS LeukoGuard ¿ Leukocy1e Reduction Arterial Blood Filter for Exh¿acorporeal Service is designed to reduce the levels of circulating leucocy1es and exclude microemboli greater than 40 ¿m in size from the perfu sate during exh¿acorporea l circulation. This included gas emboli, fat emboli and aggregates composed of platelets, red blood cells and other debris. The Pall LG6NS LeukoGuard ¿ Leukocyte Reduction Arterial Blood Filter can be included in Cardiovascular Procedure Kits (Convenience Kits). When the Pall LG6NS LeukoGuard¿ Leukocyte Reduction Arterial Blood Filters is included in the Kits, the intended use of the filter remains unaffected.
Reason for recall
Possible blood leaks through the hydrophobic portion of the Pall LG6NS LeukoGuard Leukocyte Reduction Arterial Blood Filters.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1314-2018 |
| Date reported | April 18, 2018 |
| Date initiated | December 18, 2017 |
| Recalling firm | Terumo Cardiovascular Systems Corp |
| Firm location | Ashland, MA |
| Affected scope | 2677 |
| Distribution | US Distribution to the states of : AL, OH, VA, NC, GA, NY, FL |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1314-2018) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Nationwide recalls with similar severity or category timing
Drug and device notices outside this firm and state, matched by severity timing and product category.
Similar severity · nearest report date
Same archive severity grade (Moderate), closest by report date among other firms and states.
Similar Medical Devices · nearest report date
Same product category, closest by report date among other firms and states (deduped against the severity set).
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Methodology · Corrections · Archive as of August 2026