Recall Z-2143-2020 ยท MJN Catheter, Intravascular Occluding, Temporary
Spectranetics Corporation
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
| Date | Mar 31, 2020 |
| Status | Terminated |
| 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. |
| Root cause | Labeling design |
| Action | A Field Safety Notification dated 3/31/20 was to be sent to all consignees utilizing regional sales managers and territory managers responsible for each customer account, beginning on March 31, 2020 via email or delivery in person depending on each account's restrictions due to COVID-19. The purpose of the letter was to to provide customers with an update regarding the Bridge occlusion balloon. They recently were made aware of an unpublished physician study that suggests potential formation of thrombus on the Bridge occlusion balloon when staged in patients for an extended period of time. I |
| Distribution | US: Nationwide OUS: Australia, Austria, Belgium, Canada, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Israel, Italy, Japan, Jordan, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovaki |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K153530 | Bridge Occlusion Balloon Spectranetics, Inc., Feb 5, 2016 |