Z-0894-06

Amplatz Goose Neck Microsnare Kit, Model SK400 (175 cm length x 4mm loop snare x .018'',0.46mm) and SK701...

Name: Z-0894-06 Amplatz Goose Neck Microsnare Kit, Model SK400 (175 cm length x 4mm loop snare x .018'',0.46mm) and SK701...
Creator: Ev3, Inc
Published: 2005-08-16
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2005-08-16 / Terminated

FDA source

Ev3, Inc began a recall of Amplatz Goose Neck Microsnare Kit, Model SK400 (175 cm length x 4mm loop snare x .018'',0.46mm) and SK701 (200 cm length x 7mm loop snare x 0.18'' x 0.46mm)... on 2005-08-16. The reason FDA records is "ev3 has determined that one test unit from each of two lots did not meet mininum tensile strength requirements and therefore the entire lots are being recalled". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0894-06
Status: Terminated
Initiated: 2005-08-16
Posted: 2006-06-02
Terminated: 2006-12-26
Recalling firm: Medtronic, Inc.
Product: Amplatz Goose Neck Microsnare Kit, Model SK400 (175 cm length x 4mm loop snare x .018'',0.46mm) and SK701 (200 cm length x 7mm loop snare x 0.18'' x 0.46mm) ev3, 4600 Nathan Lane North, Plymouth, Minnesota, 55442-2920 USA. For one time use only. Sterilization with Ethylene Oxide gas. Do not resterilize.------The Amplatz Goose Neck Microsnare Kit contains one Amplatz Goose Neck Microsnare, one Microcatheter, one Microsnare Introducer and one torque device.
Product code: DXE Catheter, Embolectomy
Reason for recall: ev3 has determined that one test unit from each of two lots did not meet mininum tensile strength requirements and therefore the entire lots are being recalled.
FDA root cause: Other
Action: The recall was initiated on August 16, 2005. All units distributed have been accounted for and the firm completed the recall on December 29, 2005. The firm sent a notification to customers with a Device Recall Field Action Form to record if devices remain at the sight and include with devices returned for credit or replacement.
Quantity in commerce: 58
Distribution: AL, AR, CA, CO, FL, IL, KS, MA, MO, NY, PA, TX, WA, VA, Canada, Germany, Japan
Product codes and lots: Model SK400, Lot number 277755; Model KS701, Lot number 575327

Product code DXE

K901502Class IIAmplatz Goose-Neck SnareMicrovena Corp. / cleared 1990-12-03

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)