CLASS II Device recall · Reported 23 Jan 2013 · FDA Enforcement Report
Sarns high-flow aortic arch cannula OD with connector long recalled
Terumo Cardiovascular Systems is recalling Sarns high-flow aortic arch cannula OD with connector long, with X coating surface The, distributed nationwide in the US. The recall was initiated on 7 Jan 2013 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0671-2013
- FDA event ID
- 64007
- Recalling firm
- Terumo Cardiovascular Systems, Ann Arbor, MI
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 7 Jan 2013
- FDA classified
- 11 Jan 2013
- Reported
- 23 Jan 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 7 Jan 2013 | Recall initiated by company | |
| 11 Jan 2013 | Classified by FDA | +4 days |
| 23 Jan 2013 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Flexible Arterial Cannula and High-Flow Aortic Arch Cannula connectors were identified to contain flash on the exterior of the cannula connector that exceeded established specifications. Because the flash has the potential to detach in the operative field, TCVS has decided to remove all affected lots that were manufactured with the affected connector part.
Product as listed by the FDA
Sarns high-flow aortic arch cannula, 6.5 mm (20 Fr) OD with 3/8in connector, 11in (28 cm) long, with X coating surface The Sarns" High Flow Aortic Arch Cannula and Sarns" Flexible Arterial Cannulae are indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery
Where it was distributed
Nationwide and worldwide: AL , AR , AZ , CA , CO , CT , FL , GA , HI , IA , IL , IN , KS , KY , LA , MA , ME , MI, MO , NC , ND , NV , NY , OH , OK , PA , SD , TN , TX , UT , VA , WA , and WI. Bahrain, BRAZIL, CANADA, CHILE, Honduras, Singapore, Taiwan, Trinidad and Tobago, and UNITED ARAB EMIRATES (UAE).
Nationwide AlabamaArkansasArizonaCaliforniaColoradoConnecticutFloridaGeorgiaHawaiiIowaIllinoisIndianaKansasKentuckyLouisianaMassachusettsMaineMichiganMissouriNorth Carolina
Questions about this recall
Why was it recalled?
Flexible Arterial Cannula and High-Flow Aortic Arch Cannula connectors were identified to contain flash on the exterior of the cannula connector that exceeded established specifications. Because the flash has the potential to detach in the operative field, TCVS has decided to remove all affected lots that were manufactured with the affected connector part.
Which lots are affected?
Lot number: 0677299 and Catalog number: 12325X
Where was it sold?
Nationwide and worldwide: AL , AR , AZ , CA , CO , CT , FL , GA , HI , IA , IL , IN , KS , KY , LA , MA , ME , MI, MO , NC , ND , NV , NY , OH , OK , PA , SD , TN , TX , UT , VA , WA , and WI. Bahrain, BRAZIL, CANADA, CHILE, Honduras, Singapore, Taiwan, Trinidad and Tobago, and UNITED ARAB EMIRATES (UAE).
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
5 other products · FDA event 64007This product is part of a recall event; the main page for the event is Sarns high-flow aortic arch cannula OD with connector long recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Sarns high-flow aortic arch cannula OD with connector long recalled | Terumo Cardiovascular Systems | Other | Nationwide | |
| CLASS II | Sarns flexible arterial cannula with connector, suture ring long recalled | Terumo Cardiovascular Systems | Other | Nationwide | |
| CLASS II | Sarns high-flow aortic arch cannula OD with connector long recalled | Terumo Cardiovascular Systems | Other | Nationwide | |
| CLASS II | Sarns flexible arterial cannula OD with connector recalled | Terumo Cardiovascular Systems | Other | Nationwide | |
| CLASS II | Sarns flexible arterial cannula OD with connector recalled | Terumo Cardiovascular Systems | Other | Nationwide |
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| Device | CLASS II | Getinge PVC Thoracic Catheter, Firm PVC Straight recalled | Atrium Medical | Potency & Assay | Nationwide |