Terumo Cardiovascular Systems Corporation: Medical Device Recall in 2012 - (Recall #: Z-1875-2012)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

Product Description:

Sarns Antegrade Cardioplegia Cannula: ROOT INFUSTION VENT CATHETER WITH 12 GAUGE BLUE NEEDLE RECTANGULAR FLANGE, 6" (15 CM) LONG Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in the aortic root to deliver cardioplegia solution or blood to the heart, to vent the left heart, and to aspirate air from the aorta during cardiopulmonary bypass procedures.

Product Classification:

Class II

Date Initiated: May 9, 2012

Date Posted: July 4, 2012

Recall Number: Z-1875-2012

Event ID: 61731

Reason for Recall:

During production of the Sarns Antegrade Cardioplegia Cannula, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of a foreign substance on the inner surface of some cannulae tips. Terumo CVS' preliminary investigation found that the substance can be dislodged from the cannula surface. The substance was likely deposited during the molding process, but the exact composition of the

Status: Terminated

Product Quantity: 53,139 (each) in total

Code Information:

Catalog number: 203861: 0548731, 0552411, 0556018, 0558941, 0563005, 0565138, 0565841, 0569745, 0570058, 0571163, 0571584, 0573043, 0573288, 0575518, 0580832, 0583446,0585251, 0586160, 0590448, 0591942, 0596210, 0600490, 0607020, 0618429, 0619201, 0630155, 0634777, 0640509, 0649185, 0652212, 0655898, 0661142, and 0668560.

Distribution Pattern:

Worldwide Distribution - US (nationwide) including the states of: AL, AR , AZ , CA, CT , FL, IA , IL, IN , KS , LA , MI , NM, MO , NC, NE , NJ , NV, NY , OH, OK , PA, RI , SC , TN, TX, WA , WI, WV and the countries of: BELGIUM, BRAZIL, Byelorussian SSR, CAMBODIA , Dominican Republic, Honduras, Japan, Malaysia, Mexico, Nicaragua, Saudi Arabia, Singapore, South Africa, Thailand, Trinidad and Tobago, UNITED ARAB EMIRATES (UAE), and Vietnam.

Voluntary or Mandated:

Voluntary: Firm initiated