Recall Z-1673-2013— Boston Scientific Corporation

Name: FDA recall Z-1673-2013
Creator: U.S. Food and Drug Administration
Published: 2013-05-28

Class II · Terminated

Class II FDA medical device recall by Boston Scientific Corporation, initiated 2013-05-28, terminated 2014-01-23. It names one FDA 510(k) clearance: K121614. Product: NephroMax high Pressure nephrostomy Balloon Catheter Kit. Material Number/Catalog Number: M0062101600/210-160, M0062101640/210-164 Dilation of the nephrostomy tract.. Reason: Incorrect sized renal sheath was packaged with the NephroMax high pressure nephrostomy Balloon Catheter..

Recalling firm: Boston Scientific Corporation
Classification: Class II
Status: Terminated
Initiated: 2013-05-28
Terminated: 2014-01-23
Firm location: Marlborough, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K121614 — NEPHROMAX HIGH PRESSURE NEPHROSTOMY BALOON DILATATION CATHETERBoston Scientific Corp·cleared 2012-09-18

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

NephroMax high Pressure nephrostomy Balloon Catheter Kit. Material Number/Catalog Number: M0062101600/210-160, M0062101640/210-164 Dilation of the nephrostomy tract.

Reason for recall

Incorrect sized renal sheath was packaged with the NephroMax high pressure nephrostomy Balloon Catheter.

Data sourced from openFDA. This site is unofficial and independent of the FDA.