Stretch VL Ureteral Stent Set 4.8FX22-30CM with .035 Sensor UPN: M006185155080
Reported: April 29, 2020 Initiated: March 9, 2020 #Z-1737-2020
Product Description
Stretch VL Ureteral Stent Set 4.8FX22-30CM with .035 Sensor UPN: M006185155080
Reason for Recall
An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the affected device
Details
- Recalling Firm
- Boston Scientific
- Units Affected
- 57 units
- Distribution
- Nationwide Foreign: Europe, Middle East and Africa, the Americas (North America and South America, Asia Pacific and Japan
- Location
- Marlborough, MA
Frequently Asked Questions
What product was recalled? ▼
Stretch VL Ureteral Stent Set 4.8FX22-30CM with .035 Sensor UPN: M006185155080. Recalled by Boston Scientific. Units affected: 57 units.
Why was this product recalled? ▼
An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the affected device
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 29, 2020. Severity: Moderate. Recall number: Z-1737-2020.
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