Edwards Lifesciences Anastaflo Intravascular Shunt, Model code IVS12512, IVS1512, IVS17512, IVS2012, IVS2512, IVS3012, I
FDA device recall Z-1963-2013 · posted 2013-08-14 · Terminated
Recall details
- Recalling firm
- Edwards Lifesciences, LLC
- Reason for recall
- Edwards Lifesciences is recalling certain lots of the Anastaflo intravascular Shunt due to concerns of excessive adhesive on the shunt body that may interfere with suturing of by-pass grafts.
- Action taken
- Edwards Lifesciences sent a Urgent Field Safety Notice letter dated July 30, 2013, via Fed-Ex to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The letters are tracked through customer service and as part of the customer acknowledgement letter. Customers are asked to return products. If the customer does not send back the acknowledgement letter, three additional contacts are made to notify the customer and request return of affected product. This is tracked by Edwards customer service and reported each week. We reconcile the shipments made to customers against the returned product to determine impact to distribution. Once you have verified your inventory, please complete the attached acknowledgment form and fax it back to Edwards Customer Service at 800.422.9329 within three days of receipt of this Field Safety Notice. The return of this form allows us to confirm that you have reviewed this notice and have taken appropriate action. Please contact Customer Service at 800.424.3278 to obtain a Returned Goods Authorization number and replacement product. We sincerely regret the inconvenience caused by this action and appreciate your immediate attention to this matter. The Customer Service organization can answer questions about when replacement IVS Shunts will be available. If you have questions that have not been answered by this letter, please call Edwards Customer Service at 800.424.3278 from the hours of 6:00AM - 4:30PM PST or contact your Edwards sales representative concerning the recall.
- Root cause
- Process control
- Status
- Terminated
- Product code
- DWF
- Quantity affected
- 29,618 units
- Distribution
- Nationwide and the country of Canada
- Date initiated
- 2013-07-30
- Date posted
- 2013-08-14
- Date terminated
- 2014-10-14
- Location
- Draper, UT
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| T-ANASTAFLO (K990396) | Edwards Lifesciences Research Medical | 1999-10-01 |