EndoFLIP System Recall Due to Incorrect Catheter Expiration Flags
FDA is recalling 327 EndoFLIP Systems because a software error incorrectly flags catheters as expired, making them unavailable for clinical procedures.
- Product
- EndoFLIP System that includes: ENDOFLIP 1 SYSTEM EF-100 05391530810050 10884521809307 REFURBISHED SYSTEM RFG-EF100 ENDOFLIP 1 10884521808096 05391530810166 DL ENDOFLIP 1 10884521786684 Endoscopic measuring system, including catheter components.
- Category
- Medical Device
- Distribution
- Distributed nationwide