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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 63407

7 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
November 21, 2012
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Terumo Cardiovascular Systems Corporation

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.

How coverage and grouping work

Complete imported group

Every recalled product in this event

7 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 7

24 Fr 8mm Sft Flow Str Wire W/L The Sarns Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use.

Z-0456-2013
Recall number
Z-0456-2013
Initiated
November 21, 2012
Classification
Class II
Status
Terminated
Quantity
5760 total

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
does not meet specifications

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The presence of plastic flash was identified at the tip of certain lots of Sarns Soft-Flow Aortic Cannula. The plastic flash has the potential to detach and contribute to an adverse patient effect. While this potential failure has not been reported from the field as an observed defect, it was determined that the product does not meet specifications and this condition could result in an unacceptabl

Code information

catalog number: 5841 and 5845 and lot number: 0581536 and 0581138.

Distribution pattern

Worldwide Distribution - USA including AL , CA , CO , DC , DE , FL , GA , IL , IN , KS , KY , LA , MA , MI , MO , MS , MT , NC , ND , NE , NH , NY , OH , PA , TN , TX , VA , and WI. Internationally to Australia, United Arab Emirates (UAE), Singapore, Malaysia, BELGIUM, Japan, and CANADA.

device · product 2 of 7

24 Fr 8mm Sft Flow Straight Wir The Sarns Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use

Z-0457-2013
Recall number
Z-0457-2013
Initiated
November 21, 2012
Classification
Class II
Status
Terminated
Quantity
5760 total

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
does not meet specifications

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The presence of plastic flash was identified at the tip of certain lots of Sarns Soft-Flow Aortic Cannula. The plastic flash has the potential to detach and contribute to an adverse patient effect. While this potential failure has not been reported from the field as an observed defect, it was determined that the product does not meet specifications and this condition could result in an unacceptabl

Code information

catalog number: 5843 and lot number: 0584961

Distribution pattern

Worldwide Distribution - USA including AL , CA , CO , DC , DE , FL , GA , IL , IN , KS , KY , LA , MA , MI , MO , MS , MT , NC , ND , NE , NH , NY , OH , PA , TN , TX , VA , and WI. Internationally to Australia, United Arab Emirates (UAE), Singapore, Malaysia, BELGIUM, Japan, and CANADA.

device · product 3 of 7

24 Fr 8mm Sft Flow Straight The Sarns Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use.

Z-0458-2013
Recall number
Z-0458-2013
Initiated
November 21, 2012
Classification
Class II
Status
Terminated
Quantity
5760 total

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
does not meet specifications

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The presence of plastic flash was identified at the tip of certain lots of Sarns Soft-Flow Aortic Cannula. The plastic flash has the potential to detach and contribute to an adverse patient effect. While this potential failure has not been reported from the field as an observed defect, it was determined that the product does not meet specifications and this condition could result in an unacceptabl

Code information

catalog number: 5847 and lot number: 0582251 and 0586068

Distribution pattern

Worldwide Distribution - USA including AL , CA , CO , DC , DE , FL , GA , IL , IN , KS , KY , LA , MA , MI , MO , MS , MT , NC , ND , NE , NH , NY , OH , PA , TN , TX , VA , and WI. Internationally to Australia, United Arab Emirates (UAE), Singapore, Malaysia, BELGIUM, Japan, and CANADA.

device · product 4 of 7

18 Fr 6mm Sft Flow Angled Wire The Sarns Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use.

Z-0459-2013
Recall number
Z-0459-2013
Initiated
November 21, 2012
Classification
Class II
Status
Terminated
Quantity
5760 total

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
does not meet specifications

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The presence of plastic flash was identified at the tip of certain lots of Sarns Soft-Flow Aortic Cannula. The plastic flash has the potential to detach and contribute to an adverse patient effect. While this potential failure has not been reported from the field as an observed defect, it was determined that the product does not meet specifications and this condition could result in an unacceptabl

Code information

catalog number: 7071 and lot number: 0597322, 0602541, 0610241, 0615610, 0619197, 0620809, and 0620810.

Distribution pattern

Worldwide Distribution - USA including AL , CA , CO , DC , DE , FL , GA , IL , IN , KS , KY , LA , MA , MI , MO , MS , MT , NC , ND , NE , NH , NY , OH , PA , TN , TX , VA , and WI. Internationally to Australia, United Arab Emirates (UAE), Singapore, Malaysia, BELGIUM, Japan, and CANADA.

device · product 5 of 7

18 Fr 6mm Sft Flow Ang Wire W/L The Sarns Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use.

Z-0460-2013
Recall number
Z-0460-2013
Initiated
November 21, 2012
Classification
Class II
Status
Terminated
Quantity
5760 total

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
does not meet specifications

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The presence of plastic flash was identified at the tip of certain lots of Sarns Soft-Flow Aortic Cannula. The plastic flash has the potential to detach and contribute to an adverse patient effect. While this potential failure has not been reported from the field as an observed defect, it was determined that the product does not meet specifications and this condition could result in an unacceptabl

Code information

catalog number: 7072 and lot number: 0602542, 0614871, and 0620810.

Distribution pattern

Worldwide Distribution - USA including AL , CA , CO , DC , DE , FL , GA , IL , IN , KS , KY , LA , MA , MI , MO , MS , MT , NC , ND , NE , NH , NY , OH , PA , TN , TX , VA , and WI. Internationally to Australia, United Arab Emirates (UAE), Singapore, Malaysia, BELGIUM, Japan, and CANADA.

device · product 6 of 7

24 Fr 8mm Soft Flow Ang Wire W/L The Sarns Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use.

Z-0461-2013
Recall number
Z-0461-2013
Initiated
November 21, 2012
Classification
Class II
Status
Terminated
Quantity
5760 total products

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
does not meet specifications

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The presence of plastic flash was identified at the tip of certain lots of Sarns Soft-Flow Aortic Cannula. The plastic flash has the potential to detach and contribute to an adverse patient effect. While this potential failure has not been reported from the field as an observed defect, it was determined that the product does not meet specifications and this condition could result in an unacceptabl

Code information

catalog number: 5762 and lot number: 0570466 and 0589212

Distribution pattern

Worldwide Distribution - USA including AL , CA , CO , DC , DE , FL , GA , IL , IN , KS , KY , LA , MA , MI , MO , MS , MT , NC , ND , NE , NH , NY , OH , PA , TN , TX , VA , and WI. Internationally to Australia, United Arab Emirates (UAE), Singapore, Malaysia, BELGIUM, Japan, and CANADA.

device · product 7 of 7

24 Fr 8mm Soft Flow Ang W/L The Sarns Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use.

Z-0462-2013
Recall number
Z-0462-2013
Initiated
November 21, 2012
Classification
Class II
Status
Terminated
Quantity
5760 total units

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
does not meet specifications

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The presence of plastic flash was identified at the tip of certain lots of Sarns Soft-Flow Aortic Cannula. The plastic flash has the potential to detach and contribute to an adverse patient effect. While this potential failure has not been reported from the field as an observed defect, it was determined that the product does not meet specifications and this condition could result in an unacceptabl

Code information

catalog number: 5774 and lot number: 0595116.

Distribution pattern

Worldwide Distribution - USA including AL , CA , CO , DC , DE , FL , GA , IL , IN , KS , KY , LA , MA , MI , MO , MS , MT , NC , ND , NE , NH , NY , OH , PA , TN , TX , VA , and WI. Internationally to Australia, United Arab Emirates (UAE), Singapore, Malaysia, BELGIUM, Japan, and CANADA.