Endoscopic Access Sheath Recalled Due to Risk of Intrarenal Pressure Buildup
Trokamed GmbH is recalling an endoscopic access sheath (18 Fr., 130 mm) used in gastroenterology and urology. Rapid fluid inflow may block outflow and cause dangerous pressure buildup inside the kidney.
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: This is an FDA Class I recall, the highest FDA classification level. The hazard involves serious risk of intrarenal pressure buildup during endoscopic procedures, which could cause kidney damage. Per the rubric, FDA Class I recalls are never scored below 4.
Plain-English summary
Trokamed GmbH is recalling the Sheath, 18 Fr., 130 mm (REF: WA2PS18S), an endoscopic access overtube used in gastroenterology and urology procedures. This is a FDA Class I recall of 53 units with lot number 159825.
The recall addresses a hazard with fluid inflow control during endoscopic procedures. If the inflow speed is too quick, the outflow through the shaft may be reduced due to blockage from blood, tissue fragments, or kidney stone fragments. This can result in a rapid buildup of pressure inside the kidney (intrarenal pressure).
The product was distributed in the United States (Pennsylvania) and internationally to Germany. Healthcare facilities and practitioners who have received this product should contact the manufacturer for guidance on next steps.
The recalled product
- Product
- Sheath, 18 Fr., 130 mm (REF: WA2PS18S), gastroenterology-urology endoscopic access overtube.
- Manufacturer
- Trokamed GmbH
- Affected units
- 53
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: WA2PS18S
- UDI-DI: 04251303810865
- Lot Numbers: 159825
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 Overtube May Cause Dangerous Pressure Buildup During Procedures
FDA (Devices) · 2025-01-22
Same hazard · pressure buildup
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