# K934127: Sarns Low Jetting Aortic Arch Cannula

- Pathway: 510(k) (Traditional)
- Applicant: 3M Health Care, Sarns
- Decided: Feb 22, 1994 after 181 days
- Product code: DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4210
- Recalls of this device: 41 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
12 later devices descend from it; 5 cite it directly.
2 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K060101: Estech Aortic Easy Flow Cannula (2006), 6 descendants of its own
- K083111: Impella 5.0 Catheter Family (2009), 3 descendants of its own
- K102726: Cardiohelp System (2011), 2 descendants of its own
- K091542: Estech Easyflow Cannula with Guidewire (2009), 1 descendant of its own
- K081560: Vascutek Cannula Graft, Model CGS2008S (2009), 1 descendant of its own

## Recalls of this device
- May 23, 2014 · Class II · Z-2099-2014: During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product specifications
- May 23, 2014 · Class II · Z-2105-2014: During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product specifications
- Oct 23, 2013 · Class II · Z-0193-2014: During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product specifications on certain product lots of 
- Oct 23, 2013 · Class II · Z-0196-2014: During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product specifications on certain product lots of 
- Oct 23, 2013 · Class II · Z-0194-2014: During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product specifications on certain product lots of 
- Oct 23, 2013 · Class II · Z-0195-2014: During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product specifications on certain product lots of 
- Nov 21, 2012 · Class II · Z-0456-2013: 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. Wh
- Nov 21, 2012 · Class II · Z-0462-2013: 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. Wh
- Nov 21, 2012 · Class II · Z-0458-2013: 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. Wh
- Nov 21, 2012 · Class II · Z-0460-2013: 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. Wh
- Nov 21, 2012 · Class II · Z-0461-2013: 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. Wh
- Nov 21, 2012 · Class II · Z-0459-2013: 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. Wh
- Feb 23, 2012 · Not classified · Z-1294-2012: During in-house inspection, Terumo Cardiovascular Systems discovered one Soft-Flow Aortic Cannula with a hole in the tip, just above the suture ball.
- Feb 23, 2012 · Not classified · Z-1297-2012: During in-house inspection, Terumo Cardiovascular Systems discovered one Soft-Flow Aortic Cannula with a hole in the tip, just above the suture ball.
- Feb 23, 2012 · Not classified · Z-1313-2012: During in-house inspection, Terumo Cardiovascular Systems discovered one Soft-Flow Aortic Cannula with a hole in the tip, just above the suture ball.
- Feb 23, 2012 · Not classified · Z-1302-2012: During in-house inspection, Terumo Cardiovascular Systems discovered one Soft-Flow Aortic Cannula with a hole in the tip, just above the suture ball.
- Feb 23, 2012 · Not classified · Z-1310-2012: During in-house inspection, Terumo Cardiovascular Systems discovered one Soft-Flow Aortic Cannula with a hole in the tip, just above the suture ball.
- Feb 23, 2012 · Not classified · Z-1299-2012: During in-house inspection, Terumo Cardiovascular Systems discovered one Soft-Flow Aortic Cannula with a hole in the tip, just above the suture ball.
- Feb 23, 2012 · Not classified · Z-1309-2012: During in-house inspection, Terumo Cardiovascular Systems discovered one Soft-Flow Aortic Cannula with a hole in the tip, just above the suture ball.
- Feb 23, 2012 · Not classified · Z-1300-2012: During in-house inspection, Terumo Cardiovascular Systems discovered one Soft-Flow Aortic Cannula with a hole in the tip, just above the suture ball.
- Feb 23, 2012 · Not classified · Z-1305-2012: During in-house inspection, Terumo Cardiovascular Systems discovered one Soft-Flow Aortic Cannula with a hole in the tip, just above the suture ball.
- Feb 23, 2012 · Not classified · Z-1301-2012: During in-house inspection, Terumo Cardiovascular Systems discovered one Soft-Flow Aortic Cannula with a hole in the tip, just above the suture ball.
- Feb 23, 2012 · Not classified · Z-1307-2012: During in-house inspection, Terumo Cardiovascular Systems discovered one Soft-Flow Aortic Cannula with a hole in the tip, just above the suture ball.
- Feb 23, 2012 · Not classified · Z-1293-2012: During in-house inspection, Terumo Cardiovascular Systems discovered one Soft-Flow Aortic Cannula with a hole in the tip, just above the suture ball.
- Feb 23, 2012 · Not classified · Z-1298-2012: During in-house inspection, Terumo Cardiovascular Systems discovered one Soft-Flow Aortic Cannula with a hole in the tip, just above the suture ball.
- Feb 23, 2012 · Not classified · Z-1292-2012: During in-house inspection, Terumo Cardiovascular Systems discovered one Soft-Flow Aortic Cannula with a hole in the tip, just above the suture ball.
- Feb 23, 2012 · Not classified · Z-1306-2012: During in-house inspection, Terumo Cardiovascular Systems discovered one Soft-Flow Aortic Cannula with a hole in the tip, just above the suture ball.
- Feb 23, 2012 · Not classified · Z-1296-2012: During in-house inspection, Terumo Cardiovascular Systems discovered one Soft-Flow Aortic Cannula with a hole in the tip, just above the suture ball.
- Feb 23, 2012 · Not classified · Z-1287-2012: During in-house inspection, Terumo Cardiovascular Systems discovered one Soft-Flow Aortic Cannula with a hole in the tip, just above the suture ball.
- Feb 23, 2012 · Not classified · Z-1291-2012: During in-house inspection, Terumo Cardiovascular Systems discovered one Soft-Flow Aortic Cannula with a hole in the tip, just above the suture ball.
- Feb 23, 2012 · Not classified · Z-1288-2012: During in-house inspection, Terumo Cardiovascular Systems discovered one Soft-Flow Aortic Cannula with a hole in the tip, just above the suture ball.
- Feb 23, 2012 · Not classified · Z-1304-2012: During in-house inspection, Terumo Cardiovascular Systems discovered one Soft-Flow Aortic Cannula with a hole in the tip, just above the suture ball.
- Feb 23, 2012 · Not classified · Z-1290-2012: During in-house inspection, Terumo Cardiovascular Systems discovered one Soft-Flow Aortic Cannula with a hole in the tip, just above the suture ball.
- Feb 23, 2012 · Not classified · Z-1311-2012: During in-house inspection, Terumo Cardiovascular Systems discovered one Soft-Flow Aortic Cannula with a hole in the tip, just above the suture ball.
- Feb 23, 2012 · Not classified · Z-1312-2012: During in-house inspection, Terumo Cardiovascular Systems discovered one Soft-Flow Aortic Cannula with a hole in the tip, just above the suture ball.
- Feb 23, 2012 · Not classified · Z-1295-2012: During in-house inspection, Terumo Cardiovascular Systems discovered one Soft-Flow Aortic Cannula with a hole in the tip, just above the suture ball.
- Feb 23, 2012 · Not classified · Z-1303-2012: During in-house inspection, Terumo Cardiovascular Systems discovered one Soft-Flow Aortic Cannula with a hole in the tip, just above the suture ball.
- Feb 23, 2012 · Not classified · Z-1314-2012: During in-house inspection, Terumo Cardiovascular Systems discovered one Soft-Flow Aortic Cannula with a hole in the tip, just above the suture ball.
- Feb 23, 2012 · Not classified · Z-1308-2012: During in-house inspection, Terumo Cardiovascular Systems discovered one Soft-Flow Aortic Cannula with a hole in the tip, just above the suture ball.
- Feb 23, 2012 · Not classified · Z-1289-2012: During in-house inspection, Terumo Cardiovascular Systems discovered one Soft-Flow Aortic Cannula with a hole in the tip, just above the suture ball.
- Oct 19, 2005 · Not classified · Z-0181-06: The product is labeled as sterile, but the firm has determined that the suture flange may tear through the front of the package.

Source page: https://510kreport.com/device/K934127
Methodology: https://510kreport.com/methodology