Recall Z-0852-2019— Boston Scientific Corporation

Name: FDA recall Z-0852-2019
Creator: U.S. Food and Drug Administration
Published: 2018-12-19

Class II · Terminated

Class II FDA medical device recall by Boston Scientific Corporation, initiated 2018-12-19, terminated 2020-06-09. It names one FDA 510(k) clearance: K122795. Product: Stingray" Guidewire, labeled as 300cm. intended to facilitate placement of balloon dilatation catheters or other intravascular devices during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA).. Reason: A batch of 185cm Stingray Guidewires are incorrectly labeled as 300cm guidewires..

Recalling firm: Boston Scientific Corporation
Classification: Class II
Status: Terminated
Initiated: 2018-12-19
Terminated: 2020-06-09
Firm location: Maple Grove, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K122795 — STINGRAY GUIDEWIRESBridgepoint Medical·cleared 2012-11-08

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

Stingray" Guidewire, labeled as 300cm. intended to facilitate placement of balloon dilatation catheters or other intravascular devices during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA).

Reason for recall

A batch of 185cm Stingray Guidewires are incorrectly labeled as 300cm guidewires.

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