FDA Medical Device Recalls (openFDA)
Surge Medical Sales, LLC (DBA Surge Cardiovascular): 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.
- Recall number
- Z-0068-2019
- 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.
- Status
- Terminated
- Initiated
- 2018-07-18
- Posted
- not on file
- Terminated
- 2019-04-04
- Reason
- The device was built with the rigid insertion stylet instead of the flexible stylet.
- 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: kjonas@allianthealthcare.com.
- Quantity
- 35 units
- Distribution
- US Distribution to state of: SC.
- Lot, serial or model codes
- Lot code: 00794-030718
- 510(k) numbers
- ["K964199"]
- PMA numbers
- not on file
- Product code
- DWF
- Firm FEI
- 3004986960
- Firm city
- Grand Rapids
- Firm state
- MI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28