Z-2420-2015Class II

Medtronic EOPA Arterial Cannula, Model # 77620. Lot: 2015060544 intended to deliver oxygenated blood to the...

Name: Z-2420-2015 Medtronic EOPA Arterial Cannula, Model # 77620. Lot: 2015060544 intended to deliver oxygenated blood to the...
Creator: Medtronic Perfusion Systems
Published: 2015-07-24
License: https://open.fda.gov/license/

Medtronic Perfusion Systems / initiated 2015-07-24 / Terminated / root cause: packaging

FDA source

Medtronic Perfusion Systems began a recall of Medtronic EOPA Arterial Cannula, Model # 77620. Lot: 2015060544 intended to deliver oxygenated blood to the heart during cardiopulmonary bypass procedures for... on 2015-07-24. FDA classified it as Class II and gives the reason as "EOPA Arterial Cannula Devices in this lot were shipped without the guidewire". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2420-2015
Classification: Class II
Status: Terminated
Initiated: 2015-07-24
Posted: 2015-08-19
Terminated: 2016-04-04
Recalling firm: Medtronic Perfusion Systems
Product: Medtronic EOPA Arterial Cannula, Model # 77620. Lot: 2015060544 intended to deliver oxygenated blood to the heart during cardiopulmonary bypass procedures for up to 6 hours in duration.
Product code: DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Reason for recall: EOPA Arterial Cannula Devices in this lot were shipped without the guidewire.
Root cause tag: packaging
FDA root cause: Packaging process control
Action: On July 24, 2015 Medtronic sales representatives began verbally notifying the customers of the issue, requesting quarantine and return of un-used, affected product Consignees were sent a Medtronic "Urgent Medical device Recall" letter dated August 2015. The letter was addressed to Risk Manger and Health Care Professional. The letter described the problem and the product involved in the recall. Advised consignees to quarantine and remove the product from their inventory and return it to Medtronic. Requested consignees to complete and return the Customer Confirmation Certificate via email to RS.CFQFCA@Medtronic com or fax to Medtronic 651-367-0612 to the attention of Customer Focused Quality. For questions contact your Medtronic Sales Representative or Lifeline Technical Services at 1-877-526-7890.
Quantity in commerce: 221 (111 US, 110 OUS)
Distribution: Worldwide distribution. US nationwide including: FL, GA, IL, MI, NY, NC, PA, WV; Germany, Hong Kong, and Italy.
Product codes and lots: Lot number 2015060544;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2420-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2420-2015	Class II	Terminated	Voluntary: Firm initiated	2015-08-26	2015-08-19

Product code DWF

K031037Class IIEopa Elongated One-Piece Arterial Cannula and GuidewireMedtronic Perfusion Systems / cleared 2003-05-13

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)