Terumo Cardiovascular Systems Corporation: 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.

Agency Publication Date: January 11, 2013

Affected Products

Product: Sarns flexible arterial cannula, 6.7 mm (20Fr) OD with 3/8 in. connector, suture ring, 9.5 in (24 cm) long The Sarns&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;quot; High Flow Aortic Arch Cannula and Sarns&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;quot; Flexible Arterial Cannulae are indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery

Lot number: 0677286 and Catalog number: 13010.

Lot Numbers:

number

Product: Sarns flexible arterial cannula, 7.3 mm (22 Fr) OD with 3/8in connector, suture ring, 9.5in (24 cm) long The Sarns&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;quot; High Flow Aortic Arch Cannula and Sarns&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;quot; Flexible Arterial Cannulae are indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery

Lot number: 0677284 and Catalog number: 13020

Lot Numbers:

number

Product: Sarns flexible arterial cannula, 8.0 mm (24 Fr) with 3/8in connector, suture ring, 9.5in (24 cm) long The Sarns&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;quot; High Flow Aortic Arch Cannula and Sarns&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;quot; Flexible Arterial Cannulae are indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery

Lot number: 0677287 and 0681074 and Catalog number: 13030

Lot Numbers:

number

Product: Sarns high-flow aortic arch cannula, 5.2 mm (16 Fr) OD with 3/8in connector, 7.5in (19 cm) long The Sarns&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;quot; High Flow Aortic Arch Cannula and Sarns&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;quot; Flexible Arterial Cannulae are indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery

Lot number: 0677294, 0680693, 0682187 and Catalog number: 12315

Lot Numbers:

number

Product: Sarns high-flow aortic arch cannula, 6.5 mm (20 Fr) OD with 3/8in connector, 11in (28 cm) long The Sarns&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;quot; High Flow Aortic Arch Cannula and Sarns&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;quot; Flexible Arterial Cannulae are indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery

Lot number: 0680122, 0680751and Catalog number: 12325

Lot Numbers:

number

Product: 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&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;quot; High Flow Aortic Arch Cannula and Sarns&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;quot; Flexible Arterial Cannulae are indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery

Lot number: 0677299 and Catalog number: 12325X

Lot Numbers:

number

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 64007

Status: Resolved

Manufacturer: Terumo Cardiovascular Systems Corporation

Manufactured In: United States

Units Affected: 6 products (6830 total units for all products; 6830 total all products; 6830 total all products; 6830 total all products; 6830 total all products; 6830 total all products)

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Sources: FDA iRES · Raw API Response

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Affected Products

Lot number: 0677286 and Catalog number: 13010.

Lot Numbers:

number

Lot number: 0677284 and Catalog number: 13020

Lot Numbers:

number

Lot number: 0677287 and 0681074 and Catalog number: 13030

Lot Numbers:

number

Lot number: 0677294, 0680693, 0682187 and Catalog number: 12315

Lot Numbers:

number

Lot number: 0680122, 0680751and Catalog number: 12325

Lot Numbers:

number

Lot number: 0677299 and Catalog number: 12325X

Lot Numbers:

number

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 64007

Status: Resolved

Manufacturer: Terumo Cardiovascular Systems Corporation

Manufactured In: United States

Units Affected: 6 products (6830 total units for all products; 6830 total all products; 6830 total all products; 6830 total all products; 6830 total all products; 6830 total all products)