Endoscopic Access Overtube May Cause Dangerous Pressure Buildup During Procedures
Trokamed's endoscopic access overtube may cause rapid pressure buildup in the kidney if inflow speed is too fast. The device can become obstructed by tissue and blood fragments, restricting outflow.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I classification requires a minimum severity rating of Severe (4). The device poses risk of intrarenal pressure buildup due to flow obstruction during endoscopic procedures.
Plain-English summary
Trokamed GmbH is recalling the Sheath 20 Fr., 130 mm (REF: WA2PS20S) gastroenterology-urology endoscopic access overtube.
The device poses a risk of dangerous pressure buildup inside the kidney (intrarenal pressure) if the inflow speed is too rapid during use. When inflow speed exceeds safe limits, outflow through the shaft can become restricted due to accumulation of blood, tissue fragments, and kidney stone fragments. This blockage can cause rapid pressure buildup that may result in patient harm.
This recall affects 34 units distributed within the United States (Pennsylvania) and internationally (Germany). The affected lot is 154125, identified by UDI-DI 04251303810926 and product reference number WA2PS20S.
Facilities that have used or possess this device should cease use immediately and contact Trokamed GmbH for recall instructions. Healthcare providers should evaluate patients who may have been exposed to affected devices.
The recalled product
- Product
- Sheath, 20 Fr., 130 mm (REF: WA2PS20S), gastroenterology-urology endoscopic access overtube.
- Manufacturer
- Trokamed GmbH
- Affected units
- 34
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: WA2PS20S
- UDI-DI: 04251303810926
- Lot Numbers: 154125
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 4 recalled by Trokamed GmbH under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 4 products in this recall →Related recalls
Same manufacturer · Trokamed GmbH
See all →- SevereEndoscopic Access Overtube Sheath Recalled Due to Pressure Buildup Risk
FDA (Devices) · 2025-01-22
- SevereEndoscopic Access Overtube Recalled for Risk of Obstruction and Pressure Buildup
FDA (Devices) · 2025-01-22
- SevereEndoscopic Access Sheath Recalled Due to Risk of Intrarenal Pressure Buildup
FDA (Devices) · 2025-01-22
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