DeRoyal 71-C612Recalls & reported problems
Deroyal Industries, Inc. · Tubing Suction Connector · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00749756579148), received between Jan 15, 2025 and Feb 6, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Failure to Seal” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Seal2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 6, 2025Failure to Seal; Failure to Seal
A USER FACILITY REPORTED THAT THE 6MM TUBING WAS OBSERVED HAVING DIFFICULT WITH SECUREMENT OF ITEMS WITHIN THE "GRIP" OF THE CONNECTOR PERSISTED ON ALL OF THE TUBING SKUS IN THEIR INVENTORY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21327159 ↗MalfunctionJan 15, 2025Failure to Seal; Failure to Seal
A USER FACILITY REPORTED, "WE ARE HEARING CONCERNS FROM OUR GI ENDOSCOPY TEAM THAT THE NEWLY CONVERTED DEROYAL TUBING 71C512 IS NOT SEALING AS WELL AS THE CARDINAL TUBING. SPECIFICALLY, TUBING DISLODGING FROM OUR FLEXIBLE ENDO SCOPES DURING COLONOSCOPY AND UPPER GI PROCEDURES." FOLLOW UP WAS SENT IN STATING IT INVOLVED 71-C612.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21160086 ↗
Other TUBE, ASPIRATING, FLEXIBLE, CONNECTING devices
- DeRoyal 71-C506Deroyal Industries, Inc. · TUBE, ASPIRATING, FLEXIBLE, CONNECTING1 recall4 reports
- DeRoyal 71-C512Deroyal Industries, Inc. · TUBE, ASPIRATING, FLEXIBLE, CONNECTING1 recall2 reports
- DeRoyal 71-C520Deroyal Industries, Inc. · TUBE, ASPIRATING, FLEXIBLE, CONNECTING1 recall1 report
- DeRoyal 71-C501Deroyal Industries, Inc. · TUBE, ASPIRATING, FLEXIBLE, CONNECTING1 recall0 reports
- DeRoyal 71-C510Deroyal Industries, Inc. · TUBE, ASPIRATING, FLEXIBLE, CONNECTING1 recall0 reports
- DeRoyal 71-C5100NSDeroyal Industries, Inc. · TUBE, ASPIRATING, FLEXIBLE, CONNECTING1 recall0 reports
- DeRoyal 71-C6100NSDeroyal Industries, Inc. · TUBE, ASPIRATING, FLEXIBLE, CONNECTING1 recall0 reports
- DeRoyal 71-C7100NSDeroyal Industries, Inc. · TUBE, ASPIRATING, FLEXIBLE, CONNECTING1 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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