Aortic Arterial Cannula 20 Fr (O.D.) recallZ-2159-2018 · Maquet Cardiopulmonary Ag · initiated May 14, 2018

Terminated

Is my device affected?

Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
If yours is listed, follow the instructions from Maquet Cardiopulmonary Ag or your healthcare provider. The company's action is summarized under what the company is doing.
Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

This lot of arterial cannula may have been supplied with 3/8-width de-airing plugs that could break during the process of removal from the arterial cannula.

FDA root cause category: Component design/selection

What the company is doing

Urgent Medical Device Recall letters were distributed beginning 5/14/18. The letters instructed customers to do the following: 1. Read and understand this notification, and disseminate the information provided to all users, or prospective users, of the affected arterial cannulae. 2. Check your arterial cannula inventory and compare with the Getinge part number, article number and lot number provided on Page 1 of this notification. 3. Remove any affected product that are still in your inventory and prepare it for shipment back to Getinge. 4. Call Getinge Customer Support at 1-888-627-8383 (Press Option 2 and then Option 2) for a Return Authorization (RGA) and for shipping information and label. Customer Support will issue a credit for the product return. 5. Complete, sign and promptly return the filled out response form (Page 4 of this notification) either by email to [email protected] or by fax to 1-973-860-1675.

Recall details

Recall number: Z-2159-2018
Status: Terminated
Initiated by the company: May 14, 2018
Recalling firm: Maquet Cardiopulmonary Ag
Quantity: 40 US
Product code: DWF
FDA submissions: K012774
Distribution: Worldwide distribution including US state of VA and Puerto Rico, Australia, Belgium, Brazil, Canada, Chile, Colombia, Cuba, Cyprus, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Germany, Iran, Ireland, Israel, Italy, Japan, Lebanon, Malaysia, Martinique, Mauritius, Mexico, Netherlands, New Zealand, Norway, Pakistan, Poland, Portugal, Reunion, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Syria, Thailand, Turkey, United Arab Emirates, and United Kingdom.

Product description

Aortic Arterial Cannula 20 Fr (O.D.); 23 cm (L); with 3/8-inch wide connector, Part Number 701002206, Article Number A20-0101. For use in cardiopulmonary bypass

Code information (models, lots, serial numbers)

UDI CODE: 04037691085555, Lot Number: 92196585

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

NA Art.Can.,reinf.,straight tip w.ring
Maquet Cardiopulmonary AG · CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
1 recall0 reports

Other products in the same recall event

The FDA groups related products into one recall event (event 80076).

Z-2160-2018 · Terminated
Aortic Arterial Cannula 22 Fr (O.D.); 23 cm (L); with 3/8-inch connector with LL, Part Number 701002246, Article Number A22-7107. For use in cardiopulmonary bypass
Z-2161-2018 · Terminated
Aortic Arterial Cannula 24 Fr (O.D.); 23 cm (L); with 3/8-inch connector with LL, Part Number 701002267, Article Number A24-7107. For use in cardiopulmonary bypass

Sources and updates

Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.

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