Device product
Rhythm Xience Guider Catheter Introducer with Lancer Intergrated Dilator/Transseptal Needle, Ref 112852, Sterile EO, RxOnly
Z-1768-2020
Product summary
- Event
- Event 85197
- Status
- Terminated
- Classification
- Class II
- Quantity
- 108 units
- Official record key
device-enforcement:Z-1768-2020
Official wording
Reason: It has been determined that the manufacturing process may have left foreign material particulates on the finished device. This could result in a range of event from procedure delay to pulmonary embolism.
Code information: Affected Lot Numbers/Expiration Date: 19040503 /April 2020 19052007 /May 2020 19061317 /June 2020
Distribution pattern: US: CA,SC, AZ OUS: None
Derived failure modes
-
Foreign material or chemical contamination
foreign material