Z-0918-2014Class II

Crimper Model 9100CR26 The Crimper is indicated for use in preparing the Edwards SAPIEN Transcatheter Heart...

Name: Z-0918-2014 Crimper Model 9100CR26 The Crimper is indicated for use in preparing the Edwards SAPIEN Transcatheter Heart...
Creator: Edwards Lifesciences, LLC
Published: 2014-01-20
License: https://open.fda.gov/license/

Edwards Lifesciences LLC / initiated 2014-01-20 / Terminated / root cause: manufacturing process

FDA source

Edwards Lifesciences, LLC began a recall of Crimper Model 9100CR26 The Crimper is indicated for use in preparing the Edwards SAPIEN Transcatheter Heart Valve for implantation on 2014-01-20. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0918-2014
Classification: Class II
Status: Terminated
Initiated: 2014-01-20
Posted: 2014-02-03
Terminated: 2014-03-24
Recalling firm: Edwards Lifesciences LLC
Product: Crimper Model 9100CR26 The Crimper is indicated for use in preparing the Edwards SAPIEN Transcatheter Heart Valve for implantation.
Product code: NPT Aortic Valve, Prosthesis, Percutaneously Delivered
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Edwards Lifesciences issued an Urgent Product Notice to all customers. Letters were sent via Fed Ex on 01/20/14. The letter outlines steps to be taken to enable a valve to fit into the open orifice, and allow the valve to be crimped according to normal instructions. Customers were instructed to forward the Urgent Product Notification letter to necessary personnel within their organization. Customers were also instructed to acknowledge they have reviewed and understand the notification letter by signing and dating the form included with the letter. Customers with questions were instructed to contact their Edwards Clinical Specialist.
Quantity in commerce: 422
Distribution: Nationwide Distribution
Product codes and lots: lot 59617777 and 59658495.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0918-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0918-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-12	2014-02-03

Product code NPT

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)