GE Reusable Endocavity Needle Guide H46721RRecalls & reported problems
Civco Medical Instruments CO., Inc. · Reusable non-sterile endocavity needle guide with cleaning brushes (5) for use with GE Healthcare 4DE7C, RIC5-9, and RIC6-12 transducers · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00841436114219), received between Jun 9, 2022 and Jun 9, 2022 — classified as 1 injury.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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
- Detachment of Device or Device Component1
- Off-Label Use1
Patient problems
- Vaginal Mucosa Damage1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 9, 2022Off-Label Use; Detachment of Device or Device Component; Off-Label Use; Detachment of Device or Device Component
CIVCO RECEIVED A COMPLAINT FROM OUR DISTRIBUTOR ON (B)(6) 2022 THAT A REUSABLE ENDOCAVITY NEEDLE GUIDE DID NOT STAY ATTACHED TO THE PROBE DURING USAGE AND CAUSED A LACERATION TO THE VAGINAL WALL REQUIRING A STICH TO CLOSE.
Patient problems: Vaginal Mucosa Damage
MAUDE report 14644326 ↗
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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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