Sarns D4 Aortic Arch Cannulae 6 — Class II medical device recall Z-2094-2014
Terminated recall by Terumo Cardiovascular Systems Corporation, reported 2014-07-30, distributed nationwide. During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose f
| Recall number | Z-2094-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Terumo Cardiovascular Systems Corporation, Ann Arbor, MI, United States |
| Recall initiated | 2014-05-23 |
| Classified | 2014-07-22 |
| Reported by FDA | 2014-07-30 |
| Terminated | 2015-02-24 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AU, BE, CA, CL, GB, JP, MX, MY, SG, TH, TW |
| Quantity | 7,460 units |
| Reason classes | specification failure |
| Lot numbers | 0645166, 0646481, 0649158, 0649648, 0649709, 0650489, 0650491, 0652316, 0652644, 0653227, 0653235, 0653402, 0653442, 0653856, 0654562, 0655040, 0655043, 0656440, 0658973, 0659436, 0659820, 0659824, 0660676, 0661133, 0667798, 0667803, 0668894, 0669133, 0672209, 0673024, 0673777, 0674461, 0674746, 0675018, 0675761, 0676282, 0676284, 0677655, 0678084, 0678213 and 8 more |
| Model numbers | 165264, 165265, 165266, 165267, 165269, 165765, 4344, 4400, 4460, 9482, 9483, 9484, 9485, 9486 |
Product
Sarns D4 Aortic Arch Cannulae 6.0mm, 7mm & 8mm angled and straight tip with or without side holes and/or luer Product Usage: The Sarns Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use.
Reason for recall
During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product specifications
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.