Surge Cardiovascular RMG-0015SRecalls & reported problems

Med Michigan Holdings, LLC · Retrograde Cardioplegia Cannula, Manually Inflating Smooth Balloon, Guidewire Stylet, 15Fr · Class 2

All models of Surge Cardiovascular (8)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 1
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00817278010453), received between Jul 5, 2018 and Jul 5, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Material Too Rigid or Stiff” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Device problems

Material Too Rigid or Stiff1

Patient problems

No Information1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

InjuryJul 5, 2018Material Too Rigid or Stiff
PRODUCT SEEMS TO HAVE CHANGED FROM A SOFT TO A RIGID INSERTION.
Patient problems: No Information
MAUDE report 7663611 ↗

Device details

UDI-DI	`00817278010453`
Brand	Surge Cardiovascular
Model	RMG-0015S
Company	Med Michigan Holdings, LLC
Product code	DWF · Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Sep 21, 2022

Device type (GMDN): Cardioplegia cannula

A sterile, single lumen, tubular device designed to deliver cardioplegic solution to the aortic root to stop the beating of the heart and maintain it dormant; it may also be used to vent the aorta and the left heart during a cardiopulmonary bypass procedure. It is typically made of plastic [e.g., polypropylene, polyvinyl chloride (PVC)] with a soft insertion tip and a suture flange for its anchoring; it may have one or more tubes (a second for aspiration, if needed), and typically Luer connector(s) for connection to the infusion syringe and aspiration line(s). It may include a manual tubing clamp and insertion is typically achieved with a removable stylet. This is a single-use device.

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All Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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