Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported August 21, 2013
Edwards Lifesciences Anastaflo Intravascular Shunt, Model code IVS12512, IVS1512, IVS17512, IVS2012, IVS2512, IVS3012, IVS1530, IVS2030 and IVS25 Anastaflo shunts are intended for use in preventing ischemia by shunting and/ or perfusing blood or cardioplegic solution distal to the anastomosis site during the construction of coronary artery bypass grafts30.
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-…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Edwards Lifesciences, LLC recalled Edwards Lifesciences Anastaflo Intravascular Shunt, Model code IVS12512, IVS1512, IVS1751… - a moderate-severity action.
Edwards Lifesciences Anastaflo Intravascular Shunt, Model code IVS12512, IVS1512, IVS1751… was recalled by Edwards Lifesciences, LLC in August 21, 2013. Reason: Edwards Lifesciences is recalling certain lots of the Anastaflo intravascular Shunt due to concerns of excess…. Check the official notice for the remedy. Verify recall #Z-1963-2013 with the FDA Devices before acting.
The recall
Edwards Lifesciences, LLC issued this moderate-severity FDA Devices recall-Edwards Lifesciences is recalling certain lots of the Anastaflo intravascular Shunt due to concerns of excess….
- Moderate
- severity level
- 30K units
- affected scope
- Class II
- classification
- August 21, 2013
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1963-2013 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1963-2013) was formally reported on August 21, 2013, with the manufacturer initiating the action on July 30, 2013. It is classified under Moderate severity (Class II), with a current status of Terminated. Edwards Lifesciences, LLC is listed as the recalling firm, operating out of Draper, UT. Federal records list the affected scope as 29,618 units.
The documented reason for this recall is: 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. Distribution data in the federal record shows the product reached: Nationwide and the country of Canada. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
29,618 units
Related Recalls
6
3 from same agency
Product description
Edwards Lifesciences Anastaflo Intravascular Shunt, Model code IVS12512, IVS1512, IVS17512, IVS2012, IVS2512, IVS3012, IVS1530, IVS2030 and IVS25 Anastaflo shunts are intended for use in preventing ischemia by shunting and/ or perfusing blood or cardioplegic solution distal to the anastomosis site during the construction of coronary artery bypass grafts30.
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1963-2013 |
| Date reported | August 21, 2013 |
| Date initiated | July 30, 2013 |
| Recalling firm | Edwards Lifesciences, LLC |
| Firm location | Draper, UT |
| Affected scope | 29,618 units |
| Distribution | Nationwide and the country of Canada |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1963-2013) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
Edwards Lifesciences Anastaflo Intravascular Shunt, Model code IVS12512, IVS1512, IVS17512, IVS2012, IVS2512, IVS3012, IVS1530, IVS2030 and IVS25 Anastaflo shunts are intended for use in preventing ischemia by shunting and/ or perfusing blood or cardioplegic solution distal to the anastomosis site during the construction of coronary artery bypass grafts30.. Recalled by Edwards Lifesciences, LLC. Units affected: 29,618 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 21, 2013. Severity: Moderate. Recall number: Z-1963-2013.
Where was the recalled product distributed? ▼
Distribution: Nationwide and the country of Canada.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1963-2013) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported August 21, 2013. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.