CLASS II Device recall · Reported 16 Aug 2017 · FDA Enforcement Report

Sorin Group Aortic Arch Cannula x recalled

Sorin Group USA is recalling Sorin Group Aortic Arch Cannula x, distributed nationwide in the US. The recall was initiated on 9 Jun 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel 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; Lot No. 1407000078 to 1705200165, S140979 to S141841.

Quantity recalled105,770 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2871-2017
FDA event ID: 77699
Recalling firm: Sorin Group USA, Arvada, CO
Classification: Class II
Status: Terminated
Recall initiated: 9 Jun 2017
FDA classified: 10 Aug 2017
Reported: 16 Aug 2017
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Foreign Material
Device type: Heart & Vascular Devices

Timeline

9 Jun 2017	Recall initiated by company
10 Aug 2017	Classified by FDA	+62 days
16 Aug 2017	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Identification of excess plastic on the tip of the cannula.

Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.

Product as listed by the FDA

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.

Where it was distributed

Worldwide Distribution - US Nationwide in the states of : AR, AZ, CA, GA, IL, IN, KS, MI, MN, MO, NC, NE, NY, OK, PA, SD, TX, & VA. and foreign countries of: Canada, Iran, Mexico, & New Zealand.

Nationwide Arkansas Arizona California Georgia Illinois Indiana Kansas Michigan Minnesota Missouri North Carolina Nebraska New York Oklahoma Pennsylvania South Dakota Texas Virginia

Questions about this recall

Is Sorin Group Aortic Arch Cannula x recalled?

Yes. Sorin Group USA recalled Sorin Group Aortic Arch Cannula x on 9 Jun 2017. The recall is Class II and its status is Terminated. Recall number Z-2871-2017.

Why was it recalled?

Identification of excess plastic on the tip of the cannula.

Which lots are affected?

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; Lot No. 1407000078 to 1705200165, S140979 to S141841.

Where was it sold?

Worldwide Distribution - US Nationwide in the states of : AR, AZ, CA, GA, IL, IN, KS, MI, MN, MO, NC, NE, NY, OK, PA, SD, TX, & VA. and foreign countries of: Canada, Iran, Mexico, & New Zealand.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Sorin Group USA

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15 Nov 2017Device	CLASS II	FlexFlow Venous Cannula recalled by Sorin Group USA	Sorin Group USA	Sterility	Nationwide
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