PUMA-G System™ 0010480Recalls & reported problems
Coaptech, Inc. · Percutaneous Ultrasound Gastrostomy (PUG) System Full Procedural Kit (Convenience Kit and PUSH PEG Kit) · Class 2
Data updated Oct 16, 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 00850026037319), received between Mar 26, 2026 and Mar 26, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Difficult to Advance” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Difficult to Advance1
- Difficult to Remove1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 26, 2026Difficult to Remove; Difficult to Advance
AFTER SUCCESSFULLY ESTABLISHING THROUGH-AND-THROUGH GUIDEWIRE ACCESS DURING THE PERCUTANEOUS ULTRASOUND GASTROSTOMY (PUG) PROCEDURE, THE USERS ENCOUNTERED RESISTANCE ADVANCING ADDITIONAL GUIDEWIRE OUT OF THE PATIENT'S MOUTH TO FEED THROUGH THE G-TUBE. THE CLINICAL TEAM WAS ABLE TO KEEP ADVANCING UNTIL ABOUT 40-50 CM OF GUIDEWIRE WAS OUT OF THE MOUTH AND RESISTANCE WAS MET AGAIN. THE GUIDEWIRE WAS THEN PULLED FROM THE ABDOMINAL END, AND RESISTANCE WAS MET WITH ABOUT 10 CM OUT OF THE MOUTH. THIS SEQUENCE OF ADVANCING THE GUIDEWIRE OUT OF THE MOUTH AND THEN RETRACTING AT THE ABDOMINAL END WAS COMPLETED AGAIN WITH RESISTANCE MET FROM BOTH ENDS. AFTER ADVANCING THE GUIDEWIRE OUT OF THE MOUTH AGAIN UNTIL THE RESISTANCE WAS FELT, THE G-TUBE WAS FED OVER THE GUIDEWIRE UNTIL THE TIP OF THE GUIDEWIRE WAS JUST PAST THE KNUCKLE OF THE G-TUBE AND CLAMPED TO HOLD THE G-TUBE WITH THE GUIDEWIRE. THE GUIDEWIRE WAS PULLED SLOWLY FROM THE ABDOMINAL END, AND WHEN THE TAPERED TIP OF THE G-TUBE WAS AT THE ABDOMINAL WALL, THE USER PALPATED TO ENSURE THE GUIDEWIRE WAS NOT COILED. ULTRASOUND WAS USED TO ATTEMPT TO VISUALIZE THE GUIDEWIRE, BUT IT WAS NOT SEEN. THE G-TUBE WAS PULLED THROUGH THE ABDOMINAL WAL
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24701084 ↗
Other Tube, Gastro-Enterostomy devices
- AVANOS 98431Avanos Medical, Inc. · TUBE, GASTRO-ENTEROSTOMY93 reports
- AVANOS 98432Avanos Medical, Inc. · TUBE, GASTRO-ENTEROSTOMY72 reports
- Gastrointestinal Anchor Set, SAF-T-PEXY* T-Fasteners 98701Avanos Medical, Inc. · TUBE, GASTRO-ENTEROSTOMY1 death61 reports
- Halyard 98701Avanos Medical, Inc. · TUBE, GASTRO-ENTEROSTOMY1 death40 reports
- Halyard 98431Avanos Medical, Inc. · TUBE, GASTRO-ENTEROSTOMY35 reports
- AVANOS 98433Avanos Medical, Inc. · TUBE, GASTRO-ENTEROSTOMY34 reports
- AVANOS 98430Avanos Medical, Inc. · TUBE, GASTRO-ENTEROSTOMY1 death29 reports
- Halyard 98433Avanos Medical, Inc. · TUBE, GASTRO-ENTEROSTOMY27 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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