DeRoyal CARDIAC CATH SET-UP KIT: Edwards Transducers Recalled
DeRoyal recalls CARDIAC CATH SET-UP KIT PGYBK with Edwards Life Sciences TruWave disposable pressure transducers that were previously recalled. Affected units have specific serial numbers and GTIN.
Lower-risk recall
Kit were manufactured and distributed with Edwards Life Sciences TruWave Disposable pressure transducers which were subsequently recalled by Edwards Life Sciences.
Contact the company
What happened, in plain English
DeRoyal is recalling its CARDIAC CATH SET-UP KIT PGYBK model because it includes pressure transducers previously recalled by Edwards Life Sciences. This means the kit may have faulty components that could pose safety risks if used improperly. Read more at govinfonow.com/recall/56772-deroyal-cardiac-cath-set-up-kit-edwards-transducers-recalled.
Source Summary by GovInfoNow · govinfonow.com/recall/56772-deroyal-cardiac-cath-set-up-kit-edwards-transducers-recalled · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0622-2024
Cite this page
“DeRoyal CARDIAC CATH SET-UP KIT: Edwards Transducers Recalled.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/56772-deroyal-cardiac-cath-set-up-kit-edwards-transducers-recalled. Based on FDA recall #Z-0622-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0622-2024%22&limit=1).
Why it’s dangerous
The kit includes Edwards Life Sciences TruWave disposable pressure transducers that were previously recalled by Edwards. These transducers may have manufacturing defects that could lead to inaccurate readings or other issues during medical procedures.
Who’s affected
Medical professionals using the DeRoyal CARDIAC CATH SET-UP KIT PGY: 1. Users with the specific serial numbers listed (59716839, 59867186) or GTIN 00749756364065 are affected. 2. Those using the kit for medical procedures may be at risk if the transducers are defective.
How to tell if you have this one
Check for the model number 'CARDIAC CATH SET-UP KIT PGYBK' with serial numbers '59716839' or '59867186' and GTIN 00749756364065. The product was sold with these specific identifiers.
- Brand
DeRoyal- Product
DeRoyal CARDIAC CATH SET-UP KIT PGYBK, REF 89-10572- Category
Medical device
What to do — step by step
Check Product Details
Verify the serial numbers and GTIN to confirm if your kit is affected.
Where it went and when
Where it was distributed
Distributed in Virginia.
FDA distribution: “US: Virginia” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Virginia.
Recall timeline
FDA published this recall 42 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
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-0622-2024 (November 22, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0622-2024 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 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.