Recall Z-3106-2017 ยท MJN Catheter, Intravascular Occluding, Temporary
Spectranetics Corporation
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 v
| Date | Aug 26, 2017 (initiated Aug 7, 2017) |
| Status | Terminated |
| Reason | Possible inability to pass the guidewire through the Bridge device, therefore, resulting in a potential delay of treatment. |
| Root cause | Nonconforming Material/Component |
| Action | The firm, Spectranetics, sent an "MEDICAL DEVICE RECALL" letter dated 08/07/2017 to customers via certified mail and an updated letter dated 8/17/2017 was sent on 8/23/2017. The letter described the product, problem and actions to be taken. The customers were Instructed to do the following: 1. For all Bridge inventory, we recommend physicians continue to follow product instructions to place a guide wire through the venous access site prior to the start of the procedure. Physicians may consider removing Bridge from packaging and placing the Bridge balloon over the wire prior to the start of |
| Quantity | 2,356 units |
| Distribution | Worldwide Distribution: US (nationwide) and countries of: Australia, Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Hungary, Iceland, Ireland, Israel, Italy, Kuwait, Netherlands, Norway, Poland, South Africa, Sweden, Switzerland, and United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K153530 | Bridge Occlusion Balloon Spectranetics, Inc., Feb 5, 2016 |