Z-2160-2018Class II

Aortic Arterial Cannula 22 Fr (O.D.); 23 cm (L); with 3/8-inch connector with LL, Part Number 701002246...

Name: Z-2160-2018 Aortic Arterial Cannula 22 Fr (O.D.); 23 cm (L); with 3/8-inch connector with LL, Part Number 701002246...
Creator: Maquet Cardiopulmonary Ag
Published: 2018-05-14
License: https://open.fda.gov/license/

MAQUET CARDIOPULMONARY GmbH / initiated 2018-05-14 / Terminated / root cause: design

FDA source

Maquet Cardiopulmonary Ag began a recall of 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... on 2018-05-14. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2160-2018
Classification: Class II
Status: Terminated
Initiated: 2018-05-14
Posted: 2018-06-11
Terminated: 2020-05-15
Recalling firm: MAQUET CARDIOPULMONARY GmbH
Product: 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
Product code: DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Reason for recall: 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.
Root cause tag: design
FDA root cause: Component design/selection
Action: 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.
Quantity in commerce: 470 US
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 codes and lots: UDI CODE: 04037691123813, Lot Number: 92181729 and 92181287

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2160-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2159-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-20	2018-06-11
Z-2160-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-20	2018-06-11
Z-2161-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-20	2018-06-11

Product code DWF

K012774Class IIJostra Arterial Perfusion CannulaeJostra AG / cleared 2001-11-16

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)