Z-1972-2013Class II

Edwards EndoReturn Arterial Cannula, model ER21B and ER23B

Name: Z-1972-2013 Edwards EndoReturn Arterial Cannula, model ER21B and ER23B
Creator: Edwards Lifesciences, LLC
Published: 2013-07-16
License: https://open.fda.gov/license/

Edwards Lifesciences LLC / initiated 2013-07-16 / Terminated / root cause: manufacturing process

FDA source

Edwards Lifesciences, LLC began a recall of Edwards EndoReturn Arterial Cannula, model ER21B and ER23B Product Usage: The ThruPort EndoReturn arterial cannula kit (with or without hemostasis valve), an... on 2013-07-16. FDA classified it as Class II and gives the reason as "Edwards Lifesciences is recalling certain lots of the EndoReturn Arterial Cannula that were built with an incorrect component. This component can create a performance problem with the IntraClude IntraAortic Occlusion...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1972-2013
Classification: Class II
Status: Terminated
Initiated: 2013-07-16
Posted: 2013-08-14
Terminated: 2016-11-30
Recalling firm: Edwards Lifesciences LLC
Product: Edwards EndoReturn Arterial Cannula, model ER21B and ER23B Product Usage: The ThruPort EndoReturn arterial cannula kit (with or without hemostasis valve), an introducer, a guidewire,and a connector hub. The ThruPort catheter introducer sheath kit includes a wire reinforced cannula with hemostasis valve, an introducer, and a guidewire. The cannulae have a wire reinforced section to provide kink resistance and flexibility, tapered tips to aid in insertion and advancement into the femoral artery, a non-reinforced clamp site, a 3/8 in. (9.5 mm) barbed connector, and a hemostasis valve (available on some versions) that allows passage of catheters, such as the EndoClamp aortic catheter. The introducers accept a .038 in. (0.97 mm) guidewire and are marked to simplify assembly and indicate alignment. On some versions, a connector hub secures and immobilizes the introducer within the cannula for easier, one person insertion of the cannula/introducer assembly.
Product code: DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Reason for recall: Edwards Lifesciences is recalling certain lots of the EndoReturn Arterial Cannula that were built with an incorrect component. This component can create a performance problem with the IntraClude IntraAortic Occlusion device.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Edwards sent an Urgent Field Safety Notice letter dated July 16, 2013 via Fed-Ex. The letter identified the affected product, problem and action to be taken. The letter included a Customer Acknowledgement Form to be completed and faxed to 800-422-9329 Attn: Recall Coordinator. If the customer does not send back the acknowledgement form, two additional contacts are made to notify the customer and request return of affected product. This is tracked by Edwards customer service and reported each week. Customer were requested to assess their inventory to assure that all affected product is identified and returned. Returned products will be destroyed. For questions call Edwards Customer Service at 800-424-3278.
Quantity in commerce: 855
Distribution: US Nationwide including Canada and VA sites.
Product codes and lots: Model ER21B Lots: 59496984, 59516933, 59516936, 59531385, 59531386 , 59543708 Model ER23B Lots: 59464327, 59484349, 59484350, 59484351, 59512146, 59513272, 59516940, 59534430, 59535739, 59541763

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1972-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1972-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-21	2013-08-14

Product code DWF

K971291Class IIHeartport Endoarterial Return CannulaHeartport, Inc. / cleared 1997-06-17

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)