MEDLINE CR3434CTRHRecalls & reported problems
Medline Industries, Inc. · BW CATH CABL THERMCOOL 34PN BLK-34PN RED · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10197344014163), received between Sep 24, 2026 and Sep 29, 2026 — classified as 7 malfunctions.
The most frequently reported specific device problem is “Electrical /Electronic Property 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- No Apparent Adverse Event3
- Electrical /Electronic Property Problem2
- Break1
- Material Integrity Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions7
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Electrical /Electronic Property Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50938191 ↗MalfunctionSep 29, 2026No Apparent Adverse Event
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50938088 ↗MalfunctionSep 29, 2026No Apparent Adverse Event
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50938073 ↗MalfunctionSep 29, 2026Electrical /Electronic Property Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50938060 ↗MalfunctionSep 29, 2026No Apparent Adverse Event
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50938033 ↗MalfunctionSep 29, 2026Material Integrity Problem
It was reported that "Please process the attached quality complaints."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50937999 ↗MalfunctionSep 24, 2026Break
It was reported that "Bad cable broken pin."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50889568 ↗
Other CABLE, ELECTRODE devices
- N/A ECG Leadwire set, 5-lead, grouped, grabber, AHA, mix 74 cm/ 29 in, 130 cm/ 51 inGE Healthcare Finland Oy · CABLE, ELECTRODE1 recall1 report
- N/A ECG Leadwire set, 5-lead, snap, AHA, 74 cm/ 29 inGE Healthcare Finland Oy · CABLE, ELECTRODE1 recall0 reports
- N/A ECG Leadwire set, 5-lead V2-6, snap, AHA, 74 cm/ 29 inGE Healthcare Finland Oy · CABLE, ELECTRODE1 recall0 reports
- N/A ECG Leadwire set, 3-lead, snap, AHA, 74 cm/ 29 inGE Healthcare Finland Oy · CABLE, ELECTRODE1 recall0 reports
- N/A ECG Leadwire set, 5-lead, snap, AHA, 130 cm/ 51 inGE Healthcare Finland Oy · CABLE, ELECTRODE1 recall0 reports
- N/A ECG TRUNK CABLE, 12-LEAD, AHA, 1.2 M/4 FTGE Healthcare Finland Oy · CABLE, ELECTRODE1 recall0 reports
- N/A ECG Leadwire set, 5-lead, snap, AHA, mix 74 cm/ 29 in, 130 cm/ 51 inGE Healthcare Finland Oy · CABLE, ELECTRODE1 recall0 reports
- N/A ECG TRUNK CABLE, 3-LD W/ INTEGRATED GRABBER LEAD WIRE, AHA, 3.6 M/12 FTGE Healthcare Finland Oy · CABLE, ELECTRODE1 recall0 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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