POOLE 0035070Recalls & reported problems
Conmed Corporation · POOLE Suction Instrument with Removable Sheath and Preattached 6' (1.8 m) Clear Plastic Tubing · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10653405000419), received between Sep 30, 2021 and Jan 23, 2025 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Delivered as Unsterile Product” (4 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
- Delivered as Unsterile Product4
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.
MalfunctionJan 23, 2025Delivered as Unsterile Product; Delivered as Unsterile Product
DURING INCOMING INSPECTION, THE DISTRIBUTOR REJECTED THIS DEVICE, 0035070, FOR AN INSUFFICIENT HEATSEAL. THERE WAS NO CONTACT WITH THE PATIENT AS THIS WAS FOUND DURING INCOMING INSPECTION. THIS WILL BE REPORTED AS A MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21219852 ↗MalfunctionDec 20, 2023Delivered as Unsterile Product; Delivered as Unsterile Product
DURING INCOMING INSPECTION, THE DISTRIBUTOR REJECTED THIS DEVICE, 0035070, FOR AN INSUFFICIENT HEATSEAL. THERE WAS NO CONTACT WITH THE PATIENT AS THIS WAS FOUND DURING INCOMING INSPECTION. THIS WILL BE REPORTED AS A MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18362915 ↗MalfunctionAug 18, 2022Delivered as Unsterile Product; Delivered as Unsterile Product
DURING INCOMING INSPECTION, THE DISTRIBUTOR REJECTED THIS DEVICE, 0035070, FOR AN INSUFFICIENT HEATSEAL. THERE WAS NO CONTACT WITH THE PATIENT AS THIS WAS FOUND DURING INCOMING INSPECTION. THIS WILL BE REPORTED AS A MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15249804 ↗MalfunctionSep 30, 2021Delivered as Unsterile Product; Delivered as Unsterile Product
DURING INCOMING INSPECTION, THE DISTRIBUTOR REJECTED THIS DEVICE, 0035070, FOR AN INSUFFICIENT HEATSEAL. THERE WAS NO CONTACT WITH THE PATIENT AS THIS WAS FOUND DURING INCOMING INSPECTION. THIS WILL BE REPORTED AS A MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12553511 ↗
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- Sentinel Seal 8888571562Cardinal Health 200, LLC · APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED1 recall0 reports
- Aqua-Seal 8888571406Cardinal Health 200, LLC · APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED1 recall0 reports
- Sentinel Seal 8888571513Cardinal Health 200, LLC · APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED1 recall0 reports
- Sentinel Seal 8888571489Cardinal Health 200, LLC · APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED1 recall0 reports
- spineX BONE DUST COLLECTOR S-4500Oto-Med, Inc. · Apparatus, Suction, Operating-Room, Wall Vacuum Powered1 recall0 reports
- CRD 65651-510Cardinal Health 200, LLC · APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED1 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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