Z-0068-2019Class II

Retrograde Cardioplegia Cannula, Model Number RMG-0015S The Retrograde Cardioplegia Cannula is intended for...

Name: Z-0068-2019 Retrograde Cardioplegia Cannula, Model Number RMG-0015S The Retrograde Cardioplegia Cannula is intended for...
Creator: Surge Medical Sales, LLC (DBA Surge Cardiovascular)
Published: 2018-07-18
License: https://open.fda.gov/license/

Surge Medical Sales, LLC (dba Surge Cardiovascular) / initiated 2018-07-18 / Terminated / root cause: manufacturing process

FDA source

Surge Medical Sales, LLC (DBA Surge Cardiovascular) began a recall of Retrograde Cardioplegia Cannula, Model Number RMG-0015S The Retrograde Cardioplegia Cannula is intended for use in perfusing cardioplegia solutions retrograde... on 2018-07-18. FDA classified it as Class II and gives the reason as "The device was built with the rigid insertion stylet instead of the flexible stylet". 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-0068-2019
Classification: Class II
Status: Terminated
Initiated: 2018-07-18
Posted: 2018-10-04
Terminated: 2019-04-04
Recalling firm: Surge Medical Sales, LLC (dba Surge Cardiovascular)
Product: Retrograde Cardioplegia Cannula, Model Number RMG-0015S The Retrograde Cardioplegia Cannula is intended for use in perfusing cardioplegia solutions retrograde through the coronary sinus by means of transatrial introduction.
Product code: DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Reason for recall: The device was built with the rigid insertion stylet instead of the flexible stylet.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: The firm, MediSurge, contacted its customer via email on 7/18/18. The email described the product, problem and actions to be taken. If you have any questions, contact Director of Quality Assurance/Regulatory Affairs, at 616-202-6120 or email: [email protected].
Quantity in commerce: 35 units
Distribution: US Distribution to state of: SC.
Product codes and lots: Lot code: 00794-030718

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0068-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0068-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-10	2018-10-04

Product code DWF

K964199Class IIChase Coronary Sinus Perfusion CannulaChase Medical, Inc. / cleared 1997-03-19

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)