Endoscopic Access Overtube Recalled for Risk of Obstruction and Pressure Buildup
Trokamed is recalling a 20 Fr. endoscopic access overtube due to risk of obstruction and dangerous kidney pressure buildup during procedures. If inflow speed is too quick, rapid fluid flow can restrict outflow and cause intrarenal pressure to accumulate.
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: This is an FDA Class I recall, which mandates a minimum severity score of 4. Although no illnesses or injuries are reported, the device hazard—intrarenal pressure buildup during endoscopic procedures—poses a serious risk of harm to patients.
Plain-English summary
Trokamed GmbH is recalling the Sheath 20 Fr. endoscopic access overtube (model WA2PS20L, lot 154236, UDI-DI: 04251303810919) used in gastroenterology and urology procedures.
The device carries a risk of obstruction and intrarenal pressure buildup. If inflow speed during a procedure is too quick, the outflow channel may become restricted by blood, tissue fragments, or kidney stone fragments. This can cause rapid buildup of pressure within the kidney, potentially causing harm to patients.
The recall affects 42 units distributed within Pennsylvania in the United States and in Germany internationally.
Patients and healthcare providers with affected units should consult with Trokamed GmbH for instructions regarding the recalled device.
The recalled product
- Product
- Sheath, 20 Fr., 160 mm (REF: WA2PS20L), gastroenterology-urology endoscopic access overtube.
- Manufacturer
- Trokamed GmbH
- Hazard
- obstruction
- pressure-buildup
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: WA2PS20L
- UDI-DI: 04251303810919
- Lot Numbers: 154236
Distribution
Distributed in 1 state:
- PA
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