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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 65838

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
July 30, 2013
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Edwards Lifesciences, LLC

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

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Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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.

Z-1963-2013
Recall number
Z-1963-2013
Initiated
July 30, 2013
Classification
Class II
Status
Terminated
Recalling firm
Edwards Lifesciences, LLC
Quantity
29,618 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

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Inspect official wording and provenance

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.

Code information

Model: IVS12512 Lots 58969460 to 59509355, Model: IVS1512 Lots 58914820 to 59518788, Model: IVS1530 Lots 58911395 to 59473506, Model: IVS17512 Lots 58903206 to 59546227, Model: IVS2012 Lots 58911394 to 59531271, Model: IVS2030 Lots 58932183 to 59504235, Model: IVS2512 Lots 58914819 to 59518801, Model: IVS2530 Lots 58919317 to 59463362, Model: IVS3012 Lots 58966707 to 59514116

Distribution pattern

Nationwide and the country of Canada