Recall Z-0900-2014— Boston Scientific Corporation

Name: FDA recall Z-0900-2014
Creator: U.S. Food and Drug Administration
Published: 2014-01-06

Class II · Terminated

Class II FDA medical device recall by Boston Scientific Corporation, initiated 2014-01-06, terminated 2014-10-29. It names one FDA 510(k) clearance: K080272. Product: Atlantis PV, 8.5F, 15 MHz Peripheral Imaging Catheter: Sterile, R; Sterilized using irradiation. Product Usage: This catheter is a 15 MHz ultrasound imaging catheter intended to operate with an IVUS instrument for diagnostic imaging. It is used with an 8.5F-introducer sheath and a 0.035 guidewire.. Reason: Reports of physicians experiencing inability to pass a 0.035" guidewire through the guidewire lumen and exit port at the (proximal) Y-manifold of the imaging catheter..

Recalling firm: Boston Scientific Corporation
Classification: Class II
Status: Terminated
Initiated: 2014-01-06
Terminated: 2014-10-29
Firm location: Fremont, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K080272 — ATLANTIS PVIMAGING CATHETER, MODEL H749364560Boston Scientific Corp·cleared 2008-03-11

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

Atlantis PV, 8.5F, 15 MHz Peripheral Imaging Catheter: Sterile, R; Sterilized using irradiation. Product Usage: This catheter is a 15 MHz ultrasound imaging catheter intended to operate with an IVUS instrument for diagnostic imaging. It is used with an 8.5F-introducer sheath and a 0.035 guidewire.

Reason for recall

Reports of physicians experiencing inability to pass a 0.035" guidewire through the guidewire lumen and exit port at the (proximal) Y-manifold of the imaging catheter.

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