CLASS II Device recall · Reported 20 Jan 2016 · FDA Enforcement Report
Mri Proponent" SR recalled by Boston Scientific
Boston Scientific is recalling Boston Scientific, MRI Proponent" SR, distributed nationwide in the US. The recall was initiated on 10 Dec 2015 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0620-2016
- FDA event ID
- 72855
- Recalling firm
- Boston Scientific, Saint Paul, MN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 10 Dec 2015
- FDA classified
- 8 Jan 2016
- Reported
- 20 Jan 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Pacemakers & Defibrillators
Timeline
| 10 Dec 2015 | Recall initiated by company | |
| 8 Jan 2016 | Classified by FDA | +29 days |
| 20 Jan 2016 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Boston Scientific, MRI PROPONENT" SR , REF L210 Pacemaker. These devices treat bradycardia (slow heartbeats) with RA and/or RV pacing therapy as necessary
Where it was distributed
International Distribution to countries of: COLOMBIA, JAMAICA, TRINIDAD & TOBAGO.
Questions about this recall
Is Mri Proponent" SR recalled?
Yes. Boston Scientific recalled Mri Proponent" SR on 10 Dec 2015. The recall is Class II and its status is Terminated. Recall number Z-0620-2016.
Why was it 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 lots are affected?
Serial numbers 702961, 702963, 705644, 705666, and 705947.
Where was it sold?
International Distribution to countries of: COLOMBIA, JAMAICA, TRINIDAD & TOBAGO.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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