ECG Cables and Leadsets CBL 5 Leadset, Grabber, IEC, ICURecalls & reported problems
Philips Medizin Systeme Böblingen GmbH · 5 Leadset, Grabber, IEC, ICU · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00884838011960), received between Jan 7, 2020 and Jan 7, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Deformation” (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 Deformation1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 7, 2020Material Deformation
THE CUSTOMER STATES THAT ECG LEADS WERE MOLDED INCORRECTLY. THERE WAS NO REPORTED PATIENT INCIDENT/INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9559881 ↗
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 TRUNK CABLE, 6-LEAD, AHA, 1.2 M/4 FTGE Healthcare Finland Oy · CABLE, ELECTRODE1 recall0 reports
- N/A ECG Leadwire set, 5-lead V2-6, grabber, AHA, 74 cm/ 29 inGE Healthcare Finland Oy · CABLE, ELECTRODE1 recall0 reports
- N/A ECG TRUNK CABLE, 3-LD W/ INTEGRATED GRABBER LEAD WIRE, IEC, 3.6 M/12 FTGE 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 TRUNK CABLE, 3/5-LEAD, AHA, 6 M/20 FTGE Healthcare Finland Oy · CABLE, ELECTRODE1 recall0 reports
- N/A ECG Leadwire set, 5-lead, grabber, AHA, mix 74 cm/ 29 in, 130 cm/ 51 inGE Healthcare Finland Oy · CABLE, ELECTRODE1 recall0 reports
- N/A ECG Leadwire set, 5-lead, grouped, snap, AHA, 74 cm/ 29 inGE 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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