FDA Medical Device Recalls (openFDA)
VNUS Medical Technologies Inc: VNUS 7F ClosureFAST Catheter, Order #: CF7-7-60 (60 cm working length), Manufactured by VNUS Medical Technologies, Inc., 5799 Fontanoso Way, San Jose, CA 95138
- Recall number
- Z-0542-2008
- Recalling firm
- VNUS Medical Technologies Inc
- Product
- VNUS 7F ClosureFAST Catheter, Order #: CF7-7-60 (60 cm working length), Manufactured by VNUS Medical Technologies, Inc., 5799 Fontanoso Way, San Jose, CA 95138
- Status
- Terminated
- Initiated
- 2007-08-08
- Posted
- 2008-01-24
- Terminated
- 2008-05-22
- Reason
- Instructions for Use change: Instructions for Use have been changed to include a modified placement recommendation.
- Root cause
- Labeling design
- Action
- The Recalling firm is updating the Instructions For Use, training materials, and procedural guides to incorporate the treatment recommendations. The recalling firm sent an Update to customers who received the product, Important Update Regarding the Use of the VNUS ClosureFAST Catheter, dated August 6, 2007 with supplemental device instructions. Future product distribution will include the updated labeling.
- Quantity
- 16,716 units
- Distribution
- Worldwide
- Lot, serial or model codes
- Lot #s: 319484, 274119, 274900, 275146, 275637, 276054, 277311, 277775, 278742, 279181, 279614, 279880, 279938, 280314, 280315, 280316, 285851, 286800, 287108, 287566, 288293, 292135, 292432, 293002, 293275, 293276, 293830, 293832, 294657, 294881, 294882, 295263, 296973, 298603, 299607, 299929, 300573, 301032, 301354, 302329, 302628, 303250, 303712, 303723, 304640, 304698, 305533, 305894, 306571, 306834, 307366, 307561, 307938, 307951, 308465, 309081, 309441, 309741, 309782, 310338, 310401, 310408, 310920, 311185, 312220, 312241, 312334, 313084, 313104, 313373, 313530, 313792, 314079, 314241, 314548, 314655, 315253, 315389, 315751, 315765, 315913, 315922, 316405, 316652, 316653, 316947, 317041, 317342, 317421, 318802, 319117, and 319253
- 510(k) numbers
- ["K061373"]
- PMA numbers
- not on file
- Product code
- GEI
- Firm FEI
- 3001236355
- Firm city
- San Jose
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28