Edwards Pressure Monitoring Kit with TruWave disposable pressure… — Class II medical device recall Z-2776-2015
Terminated recall by Edward Lifesciences, Llc, reported 2015-09-23, distributed nationwide. Flow restriction issues in a trifurcated IV set included in the pressure transducer kits. A restriction of the
| Recall number | Z-2776-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Edward Lifesciences, Llc, Irvine, CA, United States |
| Recall initiated | 2015-07-31 |
| Classified | 2015-09-16 |
| Reported by FDA | 2015-09-23 |
| Terminated | 2016-07-08 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, CA, CN, CO, DE, DK, FR, GB, HR, IT, NL, NZ, SE, SI |
| Lot numbers | 59976102, 59976182, 59983333, 59987950, 59987991, 59987992, 59994195, 59994210, 59994223, 59994227, 59994257, 59994267, 59998630, 59999004, 59999006, 60001398, 60001412, 60001415, 60001468, 60001473, 60001486, 60008882, 60008883, 60008919, 60008925, 60008929, 60008937, 60008942, 60014134, 60014160, 60014163, 60014177, 60019038, 60020153, 60020166, 60020168, 60020177, 60020222, 60020223, 60020235 and 61 more |
| Model numbers | 59976102, 59976182, 59983333, 59987950, 59987991, 59987992, 59994195, 59994210, 59994223, 59994227, 59994257, 59994267, 59998630, 59999004, 59999006, 60001398, 60001412, 60001415, 60001468, 60001473, 60001486, 60008882, 60008883, 60008919, 60008925 and 76 more |
Product
Edwards Pressure Monitoring Kit with TruWave disposable pressure transducer. A sterile, single-use kit that monitors pressures when attached to pressure monitoring catheters. For use on patients requiring intravascular, intracranial, or intrauterine pressure monitoring.
Reason for recall
Flow restriction issues in a trifurcated IV set included in the pressure transducer kits. A restriction of the flow of IV fluid would result in either an inability to prime the system before use or difficulty in flushing the line after a blood draw.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2776-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.