Terumo Recalls Sarns D4 Aortic Arch Cannulae Due to Particulate
Terumo CVS is recalling Sarns D4 Aortic Arch Cannulae because in-process inspections found loose fiber particulate exceeding specifications.
The agency’s classification
FDA (Devices): Class II
Class II is 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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a high-risk medical device used in surgery where particulate contamination poses a risk of harm, but the source text does not report any specific injuries or illnesses.
Plain-English summary
Terumo Cardiovascular Systems Corporation is recalling Sarns D4 Aortic Arch Cannulae, 6.0mm, 7mm, and 8mm, with angled and straight tips. These medical devices are indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. The recall involves 7,460 units.
The recall was initiated after an in-process inspection identified the presence of loose fiber particulate that exceeded finished product specifications. The affected products were distributed worldwide, including nationwide in the United States and in specific countries such as Australia, Belgium, Canada, and the United Kingdom.
Healthcare facilities and users should stop using the affected Sarns D4 Aortic Arch Cannulae and contact Terumo Cardiovascular Systems Corporation for instructions on return or replacement.
The recalled product
- 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…
- Manufacturer
- Terumo Cardiovascular Systems Corporation
- Hazard
- Affected units
- 7,460
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Part No. 165269
- Lot #: 0649648
- 0652316
- 0653402
- 0659824
- 0678725
- 0682564
- Part No. 9482
- Lot #: 0653227
- 0656440
- 0673777
- Part No. 4344
- Lot #: 0645166
- 0653856
- 0673024
- Part No. 9485
- Lot #: 654068
- Part No. 9486
- Lot #: 649867
- Part No. 4400
Distribution
Part of a larger recall action
This product is one of 13 recalled by Terumo Cardiovascular Systems Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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