Recall Z-2735-2018— Boston Scientific Corporation

Name: FDA recall Z-2735-2018
Creator: U.S. Food and Drug Administration
Published: 2017-12-11

Class II · Terminated

Class II FDA medical device recall by Boston Scientific Corporation, initiated 2017-12-11, terminated 2019-11-04. It names 2 FDA 510(k) clearances: K010853, K980453. Product: Boston Scientific Guider Softip XF Guide Catheter Product Usage: Is a neurovascular access catheter that creates a stable conduit through which interventional devices can pass. It is constructed with a polymer liner on the inside diameter for lubricity, stainless steel wire reinforcement within the wall for torque transmission and strength, and polymer materials along the length of the catheter for support and flexibility. The catheter has an atraumatic tip and a hub/strain relief combination for kink resistance (at the hub), device connectivity, and device handling.. Reason: Potential polymer material degradation..

Recalling firm: Boston Scientific Corporation
Classification: Class II
Status: Terminated
Initiated: 2017-12-11
Terminated: 2019-11-04
Firm location: Maple Grove, MN, United States

510(k) clearances named in this recall

2 on FDA's record

K010853 — GUIDER SOFTIP GUIDING CATHETER XF 5FBoston Scientific, Target·cleared 2001-04-18
K980453 — SCHNEIDER GUIDER SOFTIP GUIDING CATHETERSBoston Scientific Scimed, Inc.·cleared 1998-08-11

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

Boston Scientific Guider Softip XF Guide Catheter Product Usage: Is a neurovascular access catheter that creates a stable conduit through which interventional devices can pass. It is constructed with a polymer liner on the inside diameter for lubricity, stainless steel wire reinforcement within the wall for torque transmission and strength, and polymer materials along the length of the catheter for support and flexibility. The catheter has an atraumatic tip and a hub/strain relief combination for kink resistance (at the hub), device connectivity, and device handling.

Reason for recall

Potential polymer material degradation.

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