Z-0620-2016Class II

Boston Scientific, MRI PROPONENT" SR , REF L210 Pacemaker. These devices treat bradycardia (slow heartbeats)...

Name: Z-0620-2016 Boston Scientific, MRI PROPONENT" SR , REF L210 Pacemaker. These devices treat bradycardia (slow heartbeats)...
Creator: Boston Scientific Corporation
Published: 2015-12-10
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2015-12-10 / Terminated / root cause: labeling and UDI

FDA source

Boston Scientific Corporation began a recall of Boston Scientific, MRI PROPONENT" SR , REF L210 Pacemaker. These devices treat bradycardia (slow heartbeats) with RA and/or RV pacing therapy as necessary on 2015-12-10. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0620-2016
Classification: Class II
Status: Terminated
Initiated: 2015-12-10
Posted: 2016-01-08
Terminated: 2016-03-08
Recalling firm: Boston Scientific Corporation
Product: Boston Scientific, MRI PROPONENT" SR , REF L210 Pacemaker. These devices treat bradycardia (slow heartbeats) with RA and/or RV pacing therapy as necessary
Product code: LWP Implantable Pulse Generator, Pacemaker (Non-Crt)
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.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: The firm, Boston Scientific, sent a "Medical Device Retrieval" letter dated December 2015 to its Consignees on 12/10/2015. The letter described the problem, product involved in the recall and actions to be taken. The consignees were instructed to immediately segregate the product to ensure that it will not be used, obtain an IAN (inventory authorization number) from Boston Scientific's Logistics Department by email at [email protected]; return it back to Boston Scientific-Clonmel Cashel Rd., Clonmel Co Tipperary Ireland. If you have any questions about this retrieval contact your local Boston Scientific representative or a Technical Services representatives at 1-800-CARDIAC (227-3422) [email protected] or [email protected].
Quantity in commerce: 5
Distribution: International Distribution to countries of: COLOMBIA, JAMAICA, TRINIDAD & TOBAGO.
Product codes and lots: Serial numbers 702961, 702963, 705644, 705666, and 705947.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0620-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0620-2016	Class II	Terminated	Voluntary: Firm initiated	2016-01-20	2016-01-08
Z-0621-2016	Class II	Terminated	Voluntary: Firm initiated	2016-01-20	2016-01-08

Product code LWP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)