Proplege Coronary Sinus Catheter model PR9, 11 French Introducer, kitted with PR9. Product Usage: The catheter introduce
FDA device recall Z-1322-2013 · posted 2013-05-14 · Terminated
Recall details
- Recalling firm
- Edwards Lifesciences, LLC
- Reason for recall
- Edwards Lifesciences is recalling certain Proplege Coronary Sinus Catheter, model PR9 due to confirmed reports of blood leakage through the hemostasis valve in the introducer that is kitted with the catheter.
- Action taken
- Edwards Lifesciences sent an Urgent Field Safety Notice letter dated February 1, 2013. The letter identified the affected product, problem and actions to be taken. Customers were instructed to review entire inventory for the affected product, quarantine and return to Edwards. Contact Customer Services at 800-424-3278 for any question, to obtain a Returned Goods Authorization number and replacement product.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- DWF
- Quantity affected
- 807
- Distribution
- Worldwide Distribution - USA Nationwide including the states of: MD, NY, PA, CA, FL, AZ, AL, TX, VA, OH, MO, NC, GA, TN, CO, OR, SC, ME, IL, HI, NJ, WA, WI, CT, KY, LA and Canada.
- Date initiated
- 2013-01-25
- Date posted
- 2013-05-14
- Date terminated
- 2017-02-16
- Location
- Draper, UT
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| EDWARD PROPLEGE PERIPHERAL RETROGRADE CARDIOPLEGIA DEVICE (K120780) | Edwards Lifesciences, LLC | 2012-06-27 |