Agency classClass IIOur severity:High FDA (Devices)·Z-2147-2016·Announced 2016-07-20

Sorin Recalls Aortic Arch Cannulae Due to Incorrect Tip Angle

Sorin Group USA is recalling Aortic Arch Cannulae because the distal tip angle is 15-20 degrees instead of the specified 45 degrees.

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 medical device used in high-risk surgery (cardiopulmonary bypass) with a structural defect that deviates from design specifications. Per the rubric, this is classified as High (3) because it is a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Sorin Group USA, Inc. is recalling Aortic Arch Cannulae (part numbers NA-55X7 and NA-55X8) because the distal end of the device may be less than specified. The defective cannulae exhibit a tip angle of approximately 15-20 degrees, whereas the design specification requires an angle of approximately 45 degrees.

These devices are designed for use in the extracorporeal circuit during cardiopulmonary bypass surgery. The recall involves 5,740 units distributed nationwide in the United States (specifically to Louisiana, Michigan, Missouri, Ohio, Tennessee, and Texas) as well as to Italy and Canada.

The source text does not specify instructions for consumers or healthcare providers regarding the return or disposal of these devices. No illnesses or injuries are reported in the provided text.

The recalled product

Product: AORTIC ARCH CANNULA, Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (part numbers NA-55X7 and NA-55X8) Aortic Arch Cannulae are designed to be used in the extracorporeal circuit during cardiopulmonary bypass surgery. The cannula consists of varying lengths of…
Manufacturer: Sorin Group USA, Inc.
Category: Medical Device — Cardiopulmonary Bypass
Hazard: structural-defect
device-malfunction
Affected units: 5,740

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)

Lots: 1505600017
1505600018
1506500005
1509200078
1513100112
1513900027
1513900028
1514700045
1516600192
1516800126
1517800004
1519500037
1520100049
1520100050
1520900031
1520900033
1521600126
1523000093
1523600120
1525100023

Distribution

Distributed nationwide across the United States.

The notice also names 5 states specifically:

Same manufacturer · Sorin Group USA, Inc.

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Same hazard · structural defect