Z-1815-2008

ev3 IntraCoil Self-Expanding Peripheral Stent, Sterile EO, Model REF VT-5-60-135, Lot 4401432, Use Before...

Name: Z-1815-2008 ev3 IntraCoil Self-Expanding Peripheral Stent, Sterile EO, Model REF VT-5-60-135, Lot 4401432, Use Before...
Creator: Ev3, Inc
Published: 2008-04-02
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2008-04-02 / Terminated / root cause: manufacturing process

FDA source

Ev3, Inc began a recall of ev3 IntraCoil Self-Expanding Peripheral Stent, Sterile EO, Model REF VT-5-60-135, Lot 4401432, Use Before 2010-07. The IntraCoil is indicated for use in... on 2008-04-02. The reason FDA records is "Incorrect Label - an IntraCoil 5mm x 40 mm stent was labeled as a 5 mm x 60 mm stent (VT-5-40-135 was labeled as VT-5-60-135)". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1815-2008
Status: Terminated
Initiated: 2008-04-02
Posted: 2008-09-11
Terminated: 2011-12-10
Recalling firm: Medtronic, Inc.
Product: ev3 IntraCoil Self-Expanding Peripheral Stent, Sterile EO, Model REF VT-5-60-135, Lot 4401432, Use Before 2010-07. The IntraCoil is indicated for use in peripheral arteries in the leg in which balloon angioplasty has been applied. The IntaCoil stent is indicated for placement in flexing regions and a tortuous lesion.
Product code: NIP Stent, Superficial Femoral Artery
Reason for recall: Incorrect Label - an IntraCoil 5mm x 40 mm stent was labeled as a 5 mm x 60 mm stent (VT-5-40-135 was labeled as VT-5-60-135).
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: ev3 representative retrieved from the consignnee the affected device on 4/4/08. A Device Reconcilliation Form was requested to be filled and returned with the product.
Quantity in commerce: 3
Distribution: Nationwide Distribution including states of CA and MO.
Product codes and lots: Lot No: 4401432

Product code NIP

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)