Z-0543-2008

VNUS 7F ClosureFAST Catheter, Order # ClF7-7-100 (100 cm working length), Manufactured by VNUS Medical...

Name: Z-0543-2008 VNUS 7F ClosureFAST Catheter, Order # ClF7-7-100 (100 cm working length), Manufactured by VNUS Medical...
Creator: VNUS Medical Technologies Inc
Published: 2007-08-08
License: https://open.fda.gov/license/

Vnus Medical Technologies, Inc. / initiated 2007-08-08 / Terminated / root cause: labeling and UDI

FDA source

VNUS Medical Technologies Inc began a recall of VNUS 7F ClosureFAST Catheter, Order # ClF7-7-100 (100 cm working length), Manufactured by VNUS Medical Technologies, Inc., 5799 Fontanoso Way, San Jose, CA... on 2007-08-08. The reason FDA records is "Instructions for Use change: Instructions for Use have been changed to include a modified placement recommendation". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0543-2008
Status: Terminated
Initiated: 2007-08-08
Posted: 2008-01-24
Terminated: 2008-05-22
Recalling firm: Vnus Medical Technologies, Inc.
Product: VNUS 7F ClosureFAST Catheter, Order # ClF7-7-100 (100 cm working length), Manufactured by VNUS Medical Technologies, Inc., 5799 Fontanoso Way, San Jose, CA 95138
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall: Instructions for Use change: Instructions for Use have been changed to include a modified placement recommendation.
Root cause tag: labeling and UDI
FDA 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 in commerce: 6,221 units
Distribution: Worldwide
Product codes and lots: Lot #s: 269157, 269653, 269937, 273326, 277761, 286201, 286565, 287746, 288012, 288336, 288984, 289027, 289757, 291483, 295539, 295786, 296215, 296218, 296974, 298602, 299406, 301347, 301352, 302596, 303252, 304271, 305063, 305550, 306673, 306823, 307368, 308780, 308782, 312677, 312735, 313529, 314828, 314829, 314829, 315084, 315381, 317485, 317827, 317889, 317972, 317979, 318124, 318259, 318556, and 318610,

Product code GEI

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)