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U.S. Department of Health and Human Services

Class 1 Device Recall CVAC Aspiration System

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 Class 1 Device Recall CVAC Aspiration Systemsee related information
Date Initiated by FirmFebruary 19, 2025
Date PostedMarch 21, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1396-2025
Recall Event ID 96340
510(K)NumberK233472 
Product Classification endoscopic access overtube, gastroenterology-urology - Product Code FED
ProductCVAC Aspiration System, REF: CVC127020-1, and User Manual L00018. Intended for endoscopic examination/treatment of urinary tract and kidney interior.
Code Information CVC127020-1 UDI-DI: 00860005357710, L00018 Rev C
Recalling Firm/
Manufacturer		 Calyxo, Inc.
4473 Willow Rd
Pleasanton CA 94588-8571
Manufacturer Reason
for Recall		Aspiration system, for endoscopic examination/treatment of urinary tract and kidney interior, to have labeling update adding additional instructions, for patients with high viscosity fluid in the kidney, not to continue providing fluid inflow in the presence of unresolved slow or absent fluid outflow because this can create intrarenal pressure imbalance, and lead to excessive intrarenal pressure.
FDA Determined
Cause 2		Device Design
ActionOn 2/19/2025, correction notices were mailed to distributors and healthcare providers who were asked to do the following: 1) Notify all urologists utilizing the affected aspiration system in your institution that additional instructions are required. Please provide each of them with a copy of the additional instructions. 2) As another safety step, a firm representative will be contacting all users from your institution directly to offer training on these additional instructions. If you prefer to coordinate the training, please specifically state that preference in the acknowledgement. 3) Please acknowledge receipt of the notice, additional instructions, and updated training instructions MA00100.A by emailing qualitycontrol@calyxoinc.com, or calling 833-214-3354 and providing your name, title, institution and address.
Quantity in Commerce11,246
DistributionUS Nationwide distribution including in the states of AL, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI, WV.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = FED
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