Z-0992-2011

Steerable Coronary Sinus Catheter Kit, REF SCS01, 9 Fr x 20.4", Contains Phthalates, Sterile EO, Edwards...

Name: Z-0992-2011 Steerable Coronary Sinus Catheter Kit, REF SCS01, 9 Fr x 20.4", Contains Phthalates, Sterile EO, Edwards...
Creator: Edwards Lifesciences Llc
Published: 2010-12-03
License: https://open.fda.gov/license/

Edwards Lifesciences LLC / initiated 2010-12-03 / Terminated / root cause: design

FDA source

Edwards Lifesciences Llc began a recall of Steerable Coronary Sinus Catheter Kit, REF SCS01, 9 Fr x 20.4", Contains Phthalates, Sterile EO, Edwards Lifesciences LLC, Irvine, CA 92614. The Steerable... on 2010-12-03. The reason FDA records is "Defective product may result in the silicone valve becoming dislodged from the introducer which can result in injury". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0992-2011
Status: Terminated
Initiated: 2010-12-03
Posted: 2011-01-28
Terminated: 2011-10-27
Recalling firm: Edwards Lifesciences LLC
Product: Steerable Coronary Sinus Catheter Kit, REF SCS01, 9 Fr x 20.4", Contains Phthalates, Sterile EO, Edwards Lifesciences LLC, Irvine, CA 92614. The Steerable Coronary Sinus Catheter 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 Steerable Coronary Sinus Catheter contamination guard, is packaged with these catheters.
Product code: DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Reason for recall: Defective product may result in the silicone valve becoming dislodged from the introducer which can result in injury.
Root cause tag: design
FDA root cause: Device Design
Action: The firm, Edwards Lifesciences, sent an "URGENT PRODUCT RECALL - ACTION REQUIRED" letter dated December 3, 2010 to customers. The letter describes the product, problem and actions to be taken by the customers. The customers were instructed to check their inventory and return the unused devices; complete and return the INTROCSC Introducer Recall Response form to the attention of Customer Service, Edwards LifeSciences, One Edwards Way, Irvine, CA at 949-250-3489. If you have any questions, please contact Edwards Customer Service at 800-424-3278 from 8:00am - 4:30pm Pacific Time.
Quantity in commerce: 90 kits
Distribution: Nationwide Distribution
Product codes and lots: Lot No.: 666556, 669235, 678238, 751043, 755821, 763122

Product code DWF

K023880Class IICardio Vations Steerable Coronary Sinus CatheterETHICON, Inc. / cleared 2002-12-11

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)