Recall Z-0673-2021
Boston Scientific Corporation · initiated November 18, 2020
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
IceSphere" 1.5 90 Cryoablation Needle
Codes / lots: UPN: FPRPR3260 UDIs: 07290104830259, 07290104830259, 07290104830259, 07290104830259, 07290104830259, 07290104830259 Batch Numbers: U0326, U0325, U0286, U0285, A7012, A7011
Reason for recall
Complaint trend regarding needle shaft gas leaks.
FDA-determined cause: Under Investigation by firm
Action taken
Customers will be sent a product advisory via overnight mail.
Details
- Recall number
- Z-0673-2021
- Initiated
- November 18, 2020
- Product code
- GEH – Unit, Cryosurgical, Accessories
- Quantity
- 92 units
- Distribution
- Nationwide
- Recalling firm
- Boston Scientific Corporation, Maple Grove, MN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0657-2021 Class II | IceFORCE" 2.1 CX 90 Cryoablation NeedleComplaint trend regarding needle shaft gas leaks. | 11/18/2020Completed |
| Z-0658-2021 Class II | IceFORCE" 2.1 CX Cryoablation NeedleComplaint trend regarding needle shaft gas leaks. | 11/18/2020Completed |
| Z-0659-2021 Class II | IceFORCE" 2.1 CX L 90 Cryoablation NeedleComplaint trend regarding needle shaft gas leaks. | 11/18/2020Completed |
| Z-0660-2021 Class II | IcePearl" 2.1 CX 90 Cryoablation NeedleComplaint trend regarding needle shaft gas leaks. | 11/18/2020Completed |
| Z-0661-2021 Class II | IcePearl" 2.1 CX Cryoablation NeedleComplaint trend regarding needle shaft gas leaks. | 11/18/2020Completed |
| Z-0662-2021 Class II | IcePearl" 2.1 CX L 90 Cryoablation NeedleComplaint trend regarding needle shaft gas leaks. | 11/18/2020Completed |
| Z-0663-2021 Class II | IceRod" 1.5 CX 90 Cryoablation NeedleComplaint trend regarding needle shaft gas leaks. | 11/18/2020Completed |
| Z-0664-2021 Class II | IceSphere" 1.5 CX 90 Cryoablation NeedleComplaint trend regarding needle shaft gas leaks. | 11/18/2020Completed |
| Z-0665-2021 Class II | IceRod" 1.5 i-Thaw" Cryoablation NeedleComplaint trend regarding needle shaft gas leaks. | 11/18/2020Completed |
| Z-0666-2021 Class II | IceRod" 1.5 PLUS 90 Cryoablation NeedleComplaint trend regarding needle shaft gas leaks. | 11/18/2020Completed |
| Z-0667-2021 Class II | IceRod" 1.5 PLUS Cryoablation NeedleComplaint trend regarding needle shaft gas leaks. | 11/18/2020Completed |
| Z-0668-2021 Class II | IceRod" 1.5 90 Cryoablation NeedleComplaint trend regarding needle shaft gas leaks. | 11/18/2020Completed |
| Z-0669-2021 Class II | IceRod" 1.5 Cryoablation NeedleComplaint trend regarding needle shaft gas leaks. | 11/18/2020Completed |
| Z-0670-2021 Class II | IceSphere" 1.5 90 Cryoablation NeedleComplaint trend regarding needle shaft gas leaks. | 11/18/2020Completed |
| Z-0671-2021 Class II | IceSphere" 1.5 Cryoablation NeedleComplaint trend regarding needle shaft gas leaks. | 11/18/2020Completed |
| Z-0672-2021 Class II | IceSphere" 1.5 S 90 Cryoablation NeedleComplaint trend regarding needle shaft gas leaks. | 11/18/2020Completed |
| Z-0674-2021 Class II | IceSphere" 1.5 Cryoablation NeedleComplaint trend regarding needle shaft gas leaks. | 11/18/2020Completed |
| Z-0675-2021 Class II | IceSeed" 1.5 90 Cryoablation NeedleComplaint trend regarding needle shaft gas leaks. | 11/18/2020Completed |
| Z-0676-2021 Class II | IceSeed" 1.5 Cryoablation NeedleComplaint trend regarding needle shaft gas leaks. | 11/18/2020Completed |
| Z-0677-2021 Class II | IceEDGE" 2.4 90p Cryoablation NeedleComplaint trend regarding needle shaft gas leaks. | 11/18/2020Completed |
| Z-0678-2021 Class II | IceRod" 1.5 MRI 90 Cryoablation NeedleComplaint trend regarding needle shaft gas leaks. | 11/18/2020Completed |
| Z-0679-2021 Class II | IceRod" 1.5 MRI Cryoablation NeedleComplaint trend regarding needle shaft gas leaks. | 11/18/2020Completed |
| Z-0680-2021 Class II | IceSeed" 1.5 MRI 90 Cryoablation NeedleComplaint trend regarding needle shaft gas leaks. | 11/18/2020Completed |
| Z-0681-2021 Class II | IceSeed" 1.5 MRI Cryoablation NeedleComplaint trend regarding needle shaft gas leaks. | 11/18/2020Completed |
| Z-0682-2021 Class II | IceFORCE" 2.1 CX Prostate Cryoablation KitComplaint trend regarding needle shaft gas leaks. | 11/18/2020Completed |
| Z-0683-2021 Class II | IcePearl" 2.1 CX Prostate Cryoablation KitComplaint trend regarding needle shaft gas leaks. | 11/18/2020Completed |
| Z-0684-2021 Class II | Three IceFORCE" 2.1 CX Prostate Cryoablation KitComplaint trend regarding needle shaft gas leaks. | 11/18/2020Completed |
| Z-0685-2021 Class II | Three IcePearl" 2.1 CX Prostate Cryoablation KitComplaint trend regarding needle shaft gas leaks. | 11/18/2020Completed |
| Z-0686-2021 Class II | IceRod" i-Thaw" Prostate Cryoablation KitComplaint trend regarding needle shaft gas leaks. | 11/18/2020Completed |
| Z-0687-2021 Class II | IceSeed" Prostate Cryoablation KitComplaint trend regarding needle shaft gas leaks. | 11/18/2020Completed |