Device recall: Sarns Antegrade Cardioplegia Cannula: ROOT INFUSTION VENT CATHETER WITH 12 GAUGE BLUE NEEDLE RECTANGULAR FLANGE, 6"…
Class II FDA enforcement event 61731. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
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
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Terumo Cardiovascular Systems Corporation started this device recall on 9 May 2012. The firm address in the FDA record is in Ann Arbor, MI. FDA put the recall in Class II. FDA event 61731 has 20 product records. The first FDA enforcement report date is 4 Jul 2012. The record gives the status Terminated, with the termination date 24 Apr 2013.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
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…
Recalling firm
Terumo Cardiovascular Systems Corporation, Ann Arbor, MI.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
20 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1875-2012 | 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… | 53,139 (each) in total | Class II | Terminated | 4 Jul 2012 |
| Z-1876-2012 | SARNS ANTEGRADE: CARDIOPLEGIA CANNULA: ROOT INFUSION VENT/CATHETER WITH 14- GAUGE WHITE 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… | 53,139 (each) in total | Class II | Terminated | 4 Jul 2012 |
| Z-1877-2012 | SARNS ANTEGRADE CARDIOPLEGIA CANNULA: ROOT INFUSION CANNULA WITH 14-GAUGE WHITE NEEDLE,RECTANGULAR FLANGE AND SUTURE COLLAR, 6" (15CM) 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… | 53,139 (each) in total | Class II | Terminated | 4 Jul 2012 |
| Z-1878-2012 | SARNS ANTEGRADE CARDIOPLEGIA CANNULA: ROOT INFUSION CANNULA WITH 12-GAUGE BLUE NEEDLE,RECTANGULAR FLANGE AND SUTURE COLLAR, 6" (15CM) 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… | 53,139 (each) in total | Class II | Terminated | 4 Jul 2012 |
| Z-1879-2012 | FX PACK 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. | 53,139 (each) in total | Class II | Terminated | 4 Jul 2012 |
| Z-1880-2012 | INDIANA/OHIO HEART 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. | 53,139 (each) in total | Class II | Terminated | 4 Jul 2012 |
| Z-1881-2012 | XC HEART/LUNG PACK W/SX25RX 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. | 53,139 (each) in total | Class II | Terminated | 4 Jul 2012 |
| Z-1882-2012 | X-COATED TRANSPLANT PACK 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. | 53,139 (each) in total | Class II | Terminated | 4 Jul 2012 |
| Z-1883-2012 | X-COATED SMALL PATIENT PACK 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. | 53,139 (each) in total | Class II | Terminated | 4 Jul 2012 |
| Z-1884-2012 | X-COATED SMALL PATIENT PACK 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. | 53,139 (each) in total | Class II | Terminated | 4 Jul 2012 |
| Z-1885-2012 | MAYO MN XCOATED 3/8X1/2 AV 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. | 53,139 (each) in total | Class II | Terminated | 4 Jul 2012 |
| Z-1886-2012 | X-COATED FX25RW H/L PACK 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. | 53,139 (each) in total | Class II | Terminated | 4 Jul 2012 |
| Z-1887-2012 | X-COATED H/L PK W/FX15RW40 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. | 53,139 (each) in total | Class II | Terminated | 4 Jul 2012 |
| Z-1888-2012 | CUSTOM CPB CATHETER KIT-DR. 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. | 53,139 (each) in total | Class II | Terminated | 4 Jul 2012 |
| Z-1889-2012 | CPB CATHETER KIT-DR GERHARDT 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. | 53,139 (each) in total | Class II | Terminated | 4 Jul 2012 |
| Z-1890-2012 | CPB CATHETER KIT- DR OWEN 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. | 53,139 (each) in total | Class II | Terminated | 4 Jul 2012 |
| Z-1891-2012 | CPB CATHETER KIT- DR HENDRICKSO 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. | 53,139 (each) in total | Class II | Terminated | 4 Jul 2012 |
| Z-1892-2012 | CPB CATHETER KIT-DR VANTRIGHT 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. | 53,139 (each) in total | Class II | Terminated | 4 Jul 2012 |
| Z-1893-2012 | CPB CATHETER KIT-DR VANTRIGHT 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. | 53,139 (each) in total | Class II | Terminated | 4 Jul 2012 |
| Z-1894-2012 | CPB CATHETER KIT-DR BARTLES 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. | 53,139 (each) in total | Class II | Terminated | 4 Jul 2012 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2012
- 823
- Share of these events in Class II
- 88%
- Product records in this event
- 20Median of the firm: 2
- Events of the firm on the register
- 73
Other events of the firm
Official channels
- FDA enforcement report Z-1875-2012The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 61731. https://recallregister.com/fda/ii/61731/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
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…
- What quantity of product is in FDA event 61731?
- The event has 20 product records. The first record gives this quantity:
53,139 (each) in total
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2012 have the same class?
- 88% of the 823 device events that started in 2012 are in Class II.