Surge CardiovascularRecalls & reported problems across all models
Med Michigan Holdings, LLC · 8 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one Surge Cardiovascular model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 10
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls
- 1
We found 8 models of Surge Cardiovascular by Med Michigan Holdings, LLC in the FDA's device registry (GUDID). Together they are named in 10 adverse event reports in the FDA's MAUDE database, received between May 16, 2018 and May 15, 2026 — classified as 1 injury, 9 malfunctions.
The most frequently reported specific device problem is “Partial Blockage” (3 reports).
1 FDA recall record name at least one of these models by its device identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Surge Cardiovascular recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Nov 19, 2024Open, Classified
Incomplete or partial pouch seals, which may result in a breach in the sterility.
Z-0796-2025 · Root cause: Process control · Recall details · FDA record ↗
Most reported Surge Cardiovascular problems
Device problems
- Partial Blockage3
- Unsealed Device Packaging3
- Packaging Problem2
- Device Packaging Compromised1
- Fluid/Blood Leak1
- Material Too Rigid or Stiff1
Patient problems
- No Clinical Signs, Symptoms or Conditions8
- No Information1
- No Known Impact Or Consequence To Patient1
Surge Cardiovascular models
8 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Surge Cardiovascular SUC-4300SCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass1 recall1 report
- Surge Cardiovascular PER-1400SCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass2 reports
- Surge Cardiovascular FEM-V1024Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass2 reports
- Surge Cardiovascular ANT-1014SCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass1 report
- Surge Cardiovascular PER-1401SCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass1 report
- Surge Cardiovascular RMG-0015SCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass1 report
- Surge Cardiovascular PER-1400Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass1 report
- Surge Cardiovascular FEM-V1028Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass1 report
Recent Surge Cardiovascular adverse event reports
The 10 most recent reports across all models, 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 ↗MalfunctionSep 9, 2025Partial Blockage; Partial Blockage
CUSTOMER REPORTED OVER PRESSURIZING FREE FLOW WITH A MULTIPLE PERFUSION SET PRIOR TO USE. NO INJURY OR DEATH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23004086 ↗MalfunctionAug 22, 2025Partial Blockage; Partial Blockage
CUSTOMER REPORTED CERTAIN PORTS ARE NOT FLOWING IN MULTIPLE PERFUSION SET. NO INJURY OR DEATH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22877033 ↗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 ↗MalfunctionNov 22, 2024Unsealed Device Packaging; Unsealed Device Packaging
IT WAS REPORTED BY THE CUSTOMER A BOX CONTAINED UNSEALED POUCHES AT THE BOTTOM. THIS WAS IDENTIFIED PRIOR TO USE. NO INJURY/DEATH WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20765590 ↗MalfunctionNov 22, 2024Unsealed Device Packaging; Unsealed Device Packaging
IT WAS REPORTED BY THE CUSTOMER ONE (1) UNSEALED POUCH AT THE BOTTOM.THIS WAS IDENTIFIED PRIOR TO USE. NO INJURY/DEATH WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20763290 ↗MalfunctionOct 4, 2024Fluid/Blood Leak; Fluid/Blood Leak
CUSTOMER REPORTED PERFUSION SET LEAKING. NO PATIENT INJURY/DEATH WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20370217 ↗MalfunctionSep 6, 2023Partial Blockage; Partial Blockage
CUSTOMER REPORTED HIGH LINE PRESSURE IN MULITPLE PERFUSION SET. NO INJURY/DEATH WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17694446 ↗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 ↗MalfunctionMay 16, 2018Device Packaging Compromised
THE NEEDLE DOES NOT HAVE THE PROTECTIVE COVER ATTACHED AND IT HAS PERFORATED THE PACKAGING.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7517939 ↗
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page