Five IceSphere" Prostate Cryoablation Kit
Reported: December 30, 2020 Initiated: November 18, 2020 #Z-0689-2021
Product Description
Five IceSphere" Prostate Cryoablation Kit
Reason for Recall
Complaint trend regarding needle shaft gas leaks.
Details
- Recalling Firm
- Boston Scientific Corporation
- Units Affected
- 419 units
- Distribution
- Nationwide
- Location
- Maple Grove, MN
Frequently Asked Questions
What product was recalled? ▼
Five IceSphere" Prostate Cryoablation Kit. Recalled by Boston Scientific Corporation. Units affected: 419 units.
Why was this product recalled? ▼
Complaint trend regarding needle shaft gas leaks.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 30, 2020. Severity: Moderate. Recall number: Z-0689-2021.
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