Surge Medical Sales Recalls Retrograde Cardioplegia Cannula Due to Stylet Error
Surge Medical Sales is recalling 35 units of the Retrograde Cardioplegia Cannula because they were built with a rigid stylet instead of a flexible one.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a moderate severity score. The source text does not report any injuries, illnesses, or fatalities, and the defect is a manufacturing error regarding the stylet type.
Plain-English summary
Surge Medical Sales, LLC (DBA Surge Cardiovascular) is recalling 35 units of the Retrograde Cardioplegia Cannula, Model Number RMG-0015S. The device is intended for use in perfusing cardioplegia solutions retrograde through the coronary sinus by means of transatrial introduction.
The recall was initiated because the devices were built with a rigid insertion stylet instead of the required flexible stylet. The affected units are identified by Lot code 00794-030718.
The affected products were distributed in the United States to the state of South Carolina. Surge Medical Sales is the recalling firm.
The recalled product
- 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.
- Category
- Medical Device — Cardiac Surgery
- Affected units
- 35
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot code: 00794-030718
Distribution
Distributed in 1 state:
Related recalls
Same hazard · manufacturing defect
See all →- HighBeak & Skiff Alcohol Antiseptic Sanitizer recalled for acetaldehyde contamination
FDA (Drugs) · 2026-09-02
- HighSun Pharmaceutical Recalls Carbamazepine Tablets Due to Manufacturing Deviations
FDA (Drugs) · 2026-08-26
- HighKnee Prosthesis Trial Recall for Manufacturing Defect
FDA (Devices) · 2026-08-12
- HighU2 Total Knee System Femoral Valgus Adaptor Recall
FDA (Devices) · 2026-08-12
- HighUSTAR II Knee System Hinge Box Trial Recall
FDA (Devices) · 2026-08-12