CLASS II Device recall · Reported 12 Feb 2014 · FDA Enforcement Report
Crimper Model 9100CR26 The Crimper is indicated for use in preparing recalled
Edwards Lifesciences is recalling Crimper Model 9100CR26 The Crimper is indicated for use in preparing, distributed nationwide in the US. The recall was initiated on 20 Jan 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-0918-2014
- FDA event ID
- 67362
- Recalling firm
- Edwards Lifesciences, Draper, UT
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 20 Jan 2014
- FDA classified
- 3 Feb 2014
- Reported
- 12 Feb 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Heart & Vascular Devices
Timeline
| 20 Jan 2014 | Recall initiated by company | |
| 3 Feb 2014 | Classified by FDA | +14 days |
| 12 Feb 2014 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Edwards Lifesciences is recalling two lot numbers of the 26mm transcatheter heart valve crimper because they may not open sufficiently when the handle is rotated in the full open position. As a result, user may have difficulty fitting a 26mm Sapien transcatheter heart valve into the crimper orifice when preparing the valve for crimping.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Crimper Model 9100CR26 The Crimper is indicated for use in preparing the Edwards SAPIEN Transcatheter Heart Valve for implantation.
Where it was distributed
Nationwide Distribution
Questions about this recall
Why was it recalled?
Edwards Lifesciences is recalling two lot numbers of the 26mm transcatheter heart valve crimper because they may not open sufficiently when the handle is rotated in the full open position. As a result, user may have difficulty fitting a 26mm Sapien transcatheter heart valve into the crimper orifice when preparing the valve for crimping.
Which lots are affected?
lot 59617777 and 59658495.
Where was it sold?
Nationwide Distribution
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 Edwards Lifesciences
All 95| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Edwards Evoque tricuspid delivery system recalled | Edwards Lifesciences | Other | Nationwide |
| Device | CLASS I | Optisite Arterial Cannula recalled by Edwards Lifesciences | Edwards Lifesciences | Device Malfunction | Nationwide |
| Device | CLASS I | Fem-flexii Femoral Arterial Cannula recalled by Edwards Lifesciences | Edwards Lifesciences | Device Malfunction | Nationwide |
| Device | CLASS I | Fem-flex II Femoral Arterial Cannula recalled by Edwards Lifesciences | Edwards Lifesciences | Device Malfunction | Nationwide |
| Device | CLASS I | Fem-flex II Femoral Arterial Cannula recalled by Edwards Lifesciences | Edwards Lifesciences | Device Malfunction | 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 |