Surge Cardiovascular FEM-V1024Recalls & reported problems
Med Michigan Holdings, LLC · ALPINE Femoral Venous Cannula, 24 Fr · Class 2
All models of Surge Cardiovascular (8)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00817278012365), received between Jun 13, 2025 and May 15, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Packaging Problem” (2 reports).
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.
Reports received per month
Most reported problems
Device problems
- Packaging Problem2
- Unsealed Device Packaging1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 15, 2026Unsealed Device Packaging; Packaging Problem
IT WAS REPORTED BY THE CUSTOMER WHEN THE PRODUCT WAS TAKEN OUT OF THE BOX IT APPEARS THERE IS A PACKAGING PROBLEM WITH THE POUCH HAVING NO SEAL OR OPEN. THIS WAS IDENTIFIED PRIOR TO USE WITH NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25190779 ↗MalfunctionJun 13, 2025Packaging Problem; Packaging Problem
IT WAS REPORTED BY THE CUSTOMER WHEN THE PRODUCT WAS TAKEN OUT OF THE BOX IT APPEARS THERE IS A PACKAGING PROBLEM WITH THE POUCH SEAL BEING OPEN. THIS WAS IDENTIFIED PRIOR TO USE WITH NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22206144 ↗
Other Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass devices
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- DLP™ 77008Medtronic, Inc. · Catheter, cannula and tubing, vascular, cardiopulmonary bypass2 recalls9 reports
- NA HY11W65R1Medtronic, Inc. · Catheter, cannula and tubing, vascular, cardiopulmonary bypass2 recalls8 reports
- DLP® 12113Medtronic, Inc. · Catheter, cannula and tubing, vascular, cardiopulmonary bypass2 recalls6 reports
- DLP® Aortic Root Cannula with Flow-Guard™ 11012Medtronic, Inc. · CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS2 recalls5 reports
- EOPA™ 77622Medtronic, Inc. · Catheter, cannula and tubing, vascular, cardiopulmonary bypass2 recalls4 reports
- NA HY2V10R33Medtronic, Inc. · Catheter, cannula and tubing, vascular, cardiopulmonary bypass2 recalls3 reports
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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