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.
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, 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
- Hazard
- pressure-buildup
- fluid-obstruction
- tissue-fragment-blockage
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:
- PA
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