Z-0621-2016 Class II Terminated
FDA device recall Z-0621-2016 was initiated by Boston Scientific Corporation on Dec 10, 2015 and is designated Class II. Reason for recall: The literature packet packaged with the devices incorrectly describes the pacemaker as SR when it is actually a DR pacemaker or DR when it is actually a SR pacemaker. The recall status is terminated (terminated Mar 8, 2016). Affected quantity: 3.
Recall Details
- Product Type
- Devices
- Report Date
- Jan 20, 2016
- Initiation Date
- Dec 10, 2015
- Termination Date
- Mar 8, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3
Product Description
Boston Scientific, PROPONENT" MRI DR Pacemakers, REF L211. These devices treat bradycardia (slow heartbeats) with RA and/or RV pacing therapy as necessary.
Reason for Recall
The literature packet packaged with the devices incorrectly describes the pacemaker as SR when it is actually a DR pacemaker or DR when it is actually a SR pacemaker.
Distribution Pattern
International Distribution to countries of: COLOMBIA, JAMAICA, TRINIDAD & TOBAGO.
Code Information
Serial numbers 209409, 209518, and 209609.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0621-2016
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026