Recall Z-0440-2014— Boston Scientific Corporation
Class II · Terminated
Class II FDA medical device recall by Boston Scientific Corporation, initiated 2013-11-05, terminated 2014-12-08. FDA's recall record names no specific 510(k) clearance for this event. Product: Navigator HD l3F/15F x 28 cm Ureteral Access Sheath Set Product No M0062502270, RDF Catalog No 250-227, Sterile. Indicated for use in endoscopic procedures to facilitate the passage of endoscopes, urological instruments and for the injection of fluids into the urinary tract.. Reason: The 13F/15F Navigator HD Ureteral Access SheathSet are being recalled after receipt of 5 reports where the tip of the dilator has separated fro the body of the dilator..
- Recalling firm
- Boston Scientific Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-11-05
- Terminated
- 2014-12-08
- Firm location
- Marlborough, MA, United States
Product description
Navigator HD l3F/15F x 28 cm Ureteral Access Sheath Set Product No M0062502270, RDF Catalog No 250-227, Sterile. Indicated for use in endoscopic procedures to facilitate the passage of endoscopes, urological instruments and for the injection of fluids into the urinary tract.
Reason for recall
The 13F/15F Navigator HD Ureteral Access SheathSet are being recalled after receipt of 5 reports where the tip of the dilator has separated fro the body of the dilator.
Data sourced from openFDA. This site is unofficial and independent of the FDA.