Recall Z-3106-2017— Spectranetics Corporation
Class I · Terminated
Class I FDA medical device recall by Spectranetics Corporation, initiated 2017-08-07, terminated 2020-04-14. It names one FDA 510(k) clearance: K153530. Product: Spectranetics Bridge Occlusion Balloon catheter, Sheath Compatibility 12F, Guidewire Compatibility 0.035in, Working Length 90cm, Balloon Outer Diameter 31mm, Balloon Length 80mm, Rx Only. Product Usage: It is a device used to occlude the vessel and prevent blood loss as the physician preps for surgery resulting from an SVC tear complication of a lead extraction case. It is used for temporary vessel occlusion of the superior vena cava in applications including perioperative occlusion and emergency control of hemorrhage.. Reason: Possible inability to pass the guidewire through the Bridge device, therefore, resulting in a potential delay of treatment..
- Recalling firm
- Spectranetics Corporation
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2017-08-07
- Terminated
- 2020-04-14
- Firm location
- Colorado Springs, CO, United States
510(k) clearances named in this recall
1 on FDA's recordK-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
Spectranetics Bridge Occlusion Balloon catheter, Sheath Compatibility 12F, Guidewire Compatibility 0.035in, Working Length 90cm, Balloon Outer Diameter 31mm, Balloon Length 80mm, Rx Only. Product Usage: It is a device used to occlude the vessel and prevent blood loss as the physician preps for surgery resulting from an SVC tear complication of a lead extraction case. It is used for temporary vessel occlusion of the superior vena cava in applications including perioperative occlusion and emergency control of hemorrhage.
Reason for recall
Possible inability to pass the guidewire through the Bridge device, therefore, resulting in a potential delay of treatment.
Data sourced from openFDA. This site is unofficial and independent of the FDA.