Z-0679-2021 Class II
FDA device recall Z-0679-2021 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: 772 units.
Recall Details
- Product Type
- Devices
- Report Date
- Dec 30, 2020
- Initiation Date
- Nov 18, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 772 units
Product Description
IceRod" 1.5 MRI Cryoablation Needle¿
Reason for Recall
Complaint trend regarding needle shaft gas leaks.
Distribution Pattern
Nationwide
Code Information
UPN: FPRPR3193 UDIs: 7290104830273, 7290104830273, 7290104830273, 7290104830273, 7290104830273, 7290104830273, 7290104830273, 7290104830273, 7290104830273, 7290104830273, 7290104830273, 7290104830273, 7290104830273, 7290104830273, 7290104830273, 7290104830273, 7290104830273, 7290104830273, 7290104830273, 7290104830273, 7290104830273, 7290104830273, 7290104830273, 7290104830273, 7290104830273, 7290104830273 Batch Numbers: U1440, U1441, U1311, U1312, U1015, U1016, U0462, U0461, U0050, U0030, T0520, T0521, T0157, T0158, A7135, A7134, A6987, A6986, A6707, A6708, A6689, A6688, A1730, A1731, A1149, A1150
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0679-2021
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026