Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
X-Force Nephrostomy Balloon Dilation Catheter Kit with Inflation Device Recalled by C.R. Bard, Inc. Due to Contract manufacturer packaged an incorrect sheath with the...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact C.R. Bard, Inc. directly.
Affected Products
X-Force Nephrostomy Balloon Dilation Catheter Kit with Inflation Device, PTFE Sheath, 8 mm x 15 cm, Product Code 996081 The product is a dual lumen catheter with a 24 (8mm) or 30Fr (10mm) balloon mounted on the distal tip. It has a radiopaque tip and radiopaque marker beneath the balloon. It is recommended for use in the dilation of the nephrostomy tact and for placement of the working sheath.
Quantity: 192 units
Why Was This Recalled?
Contract manufacturer packaged an incorrect sheath with the product. Packaged 30Fr instead of 24Fr.
Where Was This Sold?
This product was distributed to 6 states: CA, KS, MO, NY, VA, WA
About C.R. Bard, Inc.
C.R. Bard, Inc. has 51 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report