Sorin Group Aortic Arch Cannula Recalled for Excess Plastic on Tip
Sorin Group USA, Inc. is recalling Aortic Arch Cannulas due to the identification of excess plastic on the tip of the device.
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 a physical defect (excess plastic) presents a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the criteria for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Sorin Group USA, Inc. is recalling Sorin Group Aortic Arch Cannulas, Model No. NA-1116 through RA-1206, due to the identification of excess plastic on the tip of the cannula. The affected units are sterile, prescription-only devices indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.
The recall covers 105,770 units distributed worldwide, including nationwide distribution in the United States and in Canada, Iran, Mexico, and New Zealand. The specific lot numbers affected range from 1407000078 to 1705200165 and S140979 to S141841.
Healthcare providers and facilities should stop using the affected cannulas and contact the manufacturer for further instructions. The source text does not report any specific illnesses, injuries, or deaths associated with this defect.
The recalled product
- Product
- Sorin Group Aortic Arch Cannula, 7 mm x 10 in x 3/8 in, Rx Only, Sterile Product Usage: The Aortic Arch Cannulae are indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.
- Manufacturer
- Sorin Group USA, Inc.
- Affected units
- 105,770
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)
- Model No. NA-1116
- NA-1118
- NA-1126
- NA-1136
- NA-1206
- NA-1207
- NA-1208
- NA-1316
- NA-1327
- NA-1337
- NA-1338
- RA-1117
- RA-1126
- RA-1127
- RA-1128A
- RA-1136
- RA-1137A
- RA-1137
- RA-1138
- RA-1206
Distribution
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