Medline ReNewal MSREP115774Recalls & reported problems
Medline Industries, Inc. · EICA5872-01 @COBLATOR II EVAC 70 XTRA PL · Class 2
All models of Medline ReNewal (18)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10888277395350), received between May 14, 2026 and Sep 23, 2026 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Component Missing” (1 report).
1 FDA recall record name this device's 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, 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
Recalls naming this device
- Mar 5, 2025Class IIOpen, Classified
Medline ReNewal has identified that the drip chambers of affected devices may disconnect from the saline line tubing when under tension.
Z-1546-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported problems
Device problems
- Component Missing1
- Detachment of Device or Device Component1
- Fluid/Blood Leak1
- Free or Unrestricted Flow1
- Material Deformation1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 23, 2026Fluid/Blood Leak; Free or Unrestricted Flow
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50874059 ↗MalfunctionSep 21, 2026Material Deformation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50846812 ↗MalfunctionAug 4, 2026Component Missing
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50132291 ↗MalfunctionMay 14, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT, THE REPROCESSED COBLATOR THAT HALF OF THE METAL TIPS ON THE END FELL OFF AND WERE DANGLING WHEN ATTEMPTING TO USE ON PATIENT. QUICKLY REMOVED DEVICE AND OPENED ANOTHER ONE AND FINISHED THE CASE WITH NO ISSUES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25179521 ↗
Other ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES devices
- Vasoview Hemopro 2 VH-4000Maquet Cardiovascular LLC · Electrosurgical, Cutting & Coagulation & Accessories6 recalls1 death3,232 reports
- LigaSure LF1937Covidien LP · Electrosurgical, cutting & coagulation & accessories3 deaths2,090 reports
- Olympus WB91051WOLYMPUS Winter & Ibe GmbH · Electrosurgical, Cutting & Coagulation & Accessories1 death1,951 reports
- Valleylab FT10 VLFT10GENCovidien LP · Electrosurgical, cutting & coagulation & accessories1 recall5 deaths1,062 reports
- LigaSure LF1837Covidien LP · ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES1 recall967 reports
- LigaSure LF2019Covidien LP · Electrosurgical, cutting & coagulation & accessories948 reports
- VAPR 225028Depuy Mitek, LLC · ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES895 reports
- LigaSure LF1923Covidien LP · Electrosurgical, cutting & coagulation & accessories855 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 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 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