Endoscopic Access Overtube Sheath Recalled Due to Pressure Buildup Risk
Trokamed GmbH is recalling an endoscopic access overtube sheath due to risk of intrarenal pressure buildup when inflow speed is too fast. No injuries reported.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The device is classified as FDA Class I, which mandates a minimum severity score of 4 per the rubric. The hazard involves potential intrarenal pressure buildup during endoscopic procedures.
Plain-English summary
Trokamed GmbH is recalling the Sheath, 18 Fr., 160 mm (REF: WA2PS18L), an endoscopic access overtube used in gastroenterology and urology procedures. The recall involves 102 units distributed in Pennsylvania and internationally to Germany, identified by lot number 154214.
If the inflow speed is too fast during use, the device can develop reduced outflow through the shaft as blood, tissue fragments, and kidney stone fragments accumulate. This obstruction can quickly cause intrarenal pressure to build up to dangerous levels, posing a risk to patient safety.
No injuries or illnesses have been reported to date. Healthcare providers and patients who have this device should be aware of the pressure buildup risk if inflow speed is not carefully controlled. Users should ensure appropriate inflow speed management during endoscopic procedures using this device.
The recalled product
- Product
- Sheath, 18 Fr., 160 mm (REF: WA2PS18L), gastroenterology-urology endoscopic access overtube.
- Manufacturer
- Trokamed GmbH
- Hazard
- intrarenal-pressure-buildup
- obstruction
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- REF: WA2PS18L
- UDI-DI: 04251303810872
- Lot Numbers: 154214
Distribution
Distributed in 1 state:
- PA
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