Boston Scientific, MRI PROPONENT" SR , REF L210 Pacemaker. These devices treat bradycardia (slow heartbeats) with RA and/or RV pacing therapy as necessary
Reported: January 20, 2016 Initiated: December 10, 2015 #Z-0620-2016
Product Description
Boston Scientific, MRI PROPONENT" SR , REF L210 Pacemaker. 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.
Details
- Recalling Firm
- Boston Scientific Corporation
- Units Affected
- 5
- Distribution
- International Distribution to countries of: COLOMBIA, JAMAICA, TRINIDAD & TOBAGO.
- Location
- Saint Paul, MN
Frequently Asked Questions
What product was recalled? ▼
Boston Scientific, MRI PROPONENT" SR , REF L210 Pacemaker. These devices treat bradycardia (slow heartbeats) with RA and/or RV pacing therapy as necessary. Recalled by Boston Scientific Corporation. Units affected: 5.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 20, 2016. Severity: Moderate. Recall number: Z-0620-2016.
Related Recalls
FDA Devices Moderate
Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.2…
Vortex Surgical Inc. · 2026-02-11
FDA Devices Moderate
COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conju…
Beckman Coulter, Inc. · 2026-02-11
FDA Devices Moderate
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These inst…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product Description: These in…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Produc…
Fujirebio Diagnostics, Inc. · 2026-02-11