Boston Scientific Ultraflex Tracheobronchial Distal Release Stent System 12mm X 30mm Material Number: M00576550 The stent system is a permanently implanted expandable metal stent designed for palliation of tracheobronchial (TB) strictures. The system consists of a flexible delivery catheter preloaded with an expandable metal stent. The stent is offered in a variety of sizes of different diameters and lengths
Reported: May 4, 2016 Initiated: March 18, 2016 #Z-1567-2016
Product Description
Boston Scientific Ultraflex Tracheobronchial Distal Release Stent System 12mm X 30mm Material Number: M00576550 The stent system is a permanently implanted expandable metal stent designed for palliation of tracheobronchial (TB) strictures. The system consists of a flexible delivery catheter preloaded with an expandable metal stent. The stent is offered in a variety of sizes of different diameters and lengths
Reason for Recall
Mislabeled: 10mm diameter x 30mm length Ultraflex Tracheobronchial stents were labeled as 12mm diameter x 30mm
Details
- Recalling Firm
- Boston Scientific Corporation
- Units Affected
- 4 units
- Distribution
- Nationwide Distribution to AL, CA, MA, and TX.
- Location
- Marlborough, MA
Frequently Asked Questions
What product was recalled? ▼
Boston Scientific Ultraflex Tracheobronchial Distal Release Stent System 12mm X 30mm Material Number: M00576550 The stent system is a permanently implanted expandable metal stent designed for palliation of tracheobronchial (TB) strictures. The system consists of a flexible delivery catheter preloaded with an expandable metal stent. The stent is offered in a variety of sizes of different diameters and lengths. Recalled by Boston Scientific Corporation. Units affected: 4 units.
Why was this product recalled? ▼
Mislabeled: 10mm diameter x 30mm length Ultraflex Tracheobronchial stents were labeled as 12mm diameter x 30mm
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 4, 2016. Severity: Moderate. Recall number: Z-1567-2016.
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