Z-0689-2021 Class II
FDA device recall Z-0689-2021 was initiated by Boston Scientific Corporation on Nov 18, 2020 and is designated Class II. Reason for recall: Complaint trend regarding needle shaft gas leaks. Affected quantity: 419 units.
Recall Details
- Product Type
- Devices
- Report Date
- Dec 30, 2020
- Initiation Date
- Nov 18, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 419 units
Product Description
Five IceSphere" Prostate Cryoablation Kit
Reason for Recall
Complaint trend regarding needle shaft gas leaks.
Distribution Pattern
Nationwide
Code Information
UPN: FPRPR3570 UDIs: 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969 Batch Numbers: U1402, U1223, U1224, U1225, U1177, U1178, U1118, U1115, U1070, U1069, U0824, U0825, U0823, U0826, U0470, U0411, U0402, U0407, U0384, U0389, U0216, U0183, U0122, U0154, U0155, T0673, T0672, T0635, T0484, T0483, T0461, T0462, T0373, T0374, T0363, T0362, T0127, T0104, T0103, A7009, A6953, A6952, A6890, A6789, A6737, A2101, A2088, A1629, A1626, A1607, A1577, A1382, A1184
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0689-2021
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026