CLASS II Device recall · Reported 13 Sep 2017 · FDA Enforcement Report
On-X Prosthetic Heart Valve with Gelweave Valsalva Graft, single use recalled
CryoLife is recalling On-X Prosthetic Heart Valve with Gelweave Valsalva Graft, single use, distributed in Illinois. The recall was initiated on 12 Feb 2014 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-3108-2017
- FDA event ID
- 77728
- Recalling firm
- CryoLife, Kennesaw, GA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 12 Feb 2014
- FDA classified
- 6 Sep 2017
- Reported
- 13 Sep 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Heart & Vascular Devices
Timeline
| 12 Feb 2014 | Recall initiated by company | |
| 6 Sep 2017 | Classified by FDA | +1302 days |
| 13 Sep 2017 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Mix-up RGA (Return Goods Authorization) leading to 5 devices being redistributed and implanted 2 patients.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
On-X Prosthetic Heart Valve with Gelweave Valsalva Graft, single use. Indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic heart valves in the aortic position in cases that involve an ascending aortic aneurysm or other associated aortic disease.
Where it was distributed
US Distribution to the state of : Illinois
Questions about this recall
Why was it recalled?
Mix-up RGA (Return Goods Authorization) leading to 5 devices being redistributed and implanted 2 patients.
Which lots are affected?
Model No. ONXAAP; Serial No. 3260716, 3718302, 3190113, 3194122 and 3634902
Where was it sold?
US Distribution to the state of : Illinois
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from CryoLife
All 14| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | BioGlue Surgical Adhesive recalled by CryoLife | CryoLife | Hidden Drug Ingredients | GA |
| Device | CLASS II | CryoPatch SG Pulmonary Human Cardiac Patch recalled by CryoLife | CryoLife | Device Malfunction | Nationwide |
| Device | CLASS II | CryoValve SG Pulmonary Human Heart Valve recalled by CryoLife | CryoLife | Device Malfunction | Nationwide |
| Device | CLASS II | CryoPatch SG Pulmonary Hemi-Artery Patch recalled by CryoLife | CryoLife | Other | TX |
| Device | CLASS II | On-X Aortic Heart Valve with Anatomic Sewing Ring recalled by CryoLife | CryoLife | Labeling Errors | Nationwide |
Other Heart & Vascular Devices recalls
All 6,199| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled | Atrium Medical | Potency & Assay | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes: *Bardex¿ I.C recalled | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Getinge PVC Thoracic Catheter, Firm PVC Straight recalled | Atrium Medical | Potency & Assay | Nationwide |