Z-2777-2011

Steerable Coronary Sinus Catheter, Model SCS01, 9 Fr x 20.4", Sterile R, Edwards Lifesciences Port Access...

Name: Z-2777-2011 Steerable Coronary Sinus Catheter, Model SCS01, 9 Fr x 20.4", Sterile R, Edwards Lifesciences Port Access...
Creator: Edwards Lifesciences, LLC
Published: 2011-06-15
License: https://open.fda.gov/license/

Edwards Lifesciences LLC / initiated 2011-06-15 / Terminated / root cause: manufacturing process

FDA source

Edwards Lifesciences, LLC began a recall of Steerable Coronary Sinus Catheter, Model SCS01, 9 Fr x 20.4", Sterile R, Edwards Lifesciences Port Access Systems. Device is a three-lumen, 9 Fr catheter with... on 2011-06-15. The reason FDA records is "Possibility of separation of the introducer sheath from the hub on Coronary Sinus Catheters". 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-2777-2011
Status: Terminated
Initiated: 2011-06-15
Posted: 2011-07-11
Terminated: 2012-06-01
Recalling firm: Edwards Lifesciences LLC
Product: Steerable Coronary Sinus Catheter, Model SCS01, 9 Fr x 20.4", Sterile R, Edwards Lifesciences Port Access Systems. Device is a three-lumen, 9 Fr catheter with an elastomeric balloon near its tip for occluding the coronary sinus in order to retrograde perfuse the coronary circulation. An 11 Fr catheter introducer sheath, which is compatible with the catheter contamination guard, is packaged with these catheters.
Product code: DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Reason for recall: Possibility of separation of the introducer sheath from the hub on Coronary Sinus Catheters.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: Edwards Lifesciences, LLC sent an Urgent Product Recall - Action Required letter dated June 15, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Cusotmers were instructed to check their inventory for any affected product and return all unused product from their stock to Edwards at: Edwards Lifesciences 12060 Lone Peak Pkwy Draper, UT 84020 Attention: Suzanne Carpenter, RGA # Customers were instructed to contact Customer Service to obtain a Returned Goods Authorization number and replacement product . Once customers verified their inventory, they were to complete the attached form and fax it to Edwards at (949) 250-3489. For any questions customers were instructed to call Edwards Customer Service at (800) 424-3278.
Quantity in commerce: 97 units
Distribution: Nationwide Distribution.
Product codes and lots: Lot numbers: 678238B, 751043B, 755821B, 763122B.

Product code DWF

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)