Recall Z-2143-2020— Spectranetics Corporation

Name: FDA recall Z-2143-2020
Creator: U.S. Food and Drug Administration
Published: 2020-03-31

Class II · Terminated

Class II FDA medical device recall by Spectranetics Corporation, initiated 2020-03-31, terminated 2022-10-31. It names one FDA 510(k) clearance: K153530. Product: Bridge Occlusion Balloon, REF 590-001, QTY 1, Sheath Compatibility 12F, Guidewire Compatibility 0.035 in, Working Length 90 cm, Balloon Outer Diameter 31 mm, Balloon Length 80 mmm, Rx ONLY, CE Marking, Sterile EO, UDI: 00813132024666. Reason: There is a potential for thrombus formation on balloons prepped and staged in the vasculature for long durations. All users, such as those performing lead extraction cases may not be aware of this risk. It was determined that current labeling is insufficient to ensure all potential users minimize the time the balloon remains in vasculature. If left in too long it could lead to embolization..

Recalling firm: Spectranetics Corporation
Classification: Class II
Status: Terminated
Initiated: 2020-03-31
Terminated: 2022-10-31
Firm location: Colorado Springs, CO, United States

510(k) clearances named in this recall

1 on FDA's record

K153530 — Bridge Occlusion BalloonSpectranetics, Inc.·cleared 2016-02-05

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

Bridge Occlusion Balloon, REF 590-001, QTY 1, Sheath Compatibility 12F, Guidewire Compatibility 0.035 in, Working Length 90 cm, Balloon Outer Diameter 31 mm, Balloon Length 80 mmm, Rx ONLY, CE Marking, Sterile EO, UDI: 00813132024666

Reason for recall

There is a potential for thrombus formation on balloons prepped and staged in the vasculature for long durations. All users, such as those performing lead extraction cases may not be aware of this risk. It was determined that current labeling is insufficient to ensure all potential users minimize the time the balloon remains in vasculature. If left in too long it could lead to embolization.

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