Z-0938-2017Class II

Boston Scientific, INGEVITY" MRI Leads, Sterile EO, RxOnly

Name: Z-0938-2017 Boston Scientific, INGEVITY" MRI Leads, Sterile EO, RxOnly
Creator: Boston Scientific Corporation
Published: 2016-11-30
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2016-11-30 / Terminated / root cause: manufacturing process

FDA source

Boston Scientific Corporation began a recall of Boston Scientific, INGEVITY" MRI Leads, Sterile EO, RxOnly on 2016-11-30. FDA classified it as Class II and gives the reason as "Boston Scientific is conducting a recall on Boston Scientific INGEVITY" MRI endocardial pacing leads. There is a possibility that the polyurethane boot at the terminal end of the lead was not securely connected to the...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0938-2017
Classification: Class II
Status: Terminated
Initiated: 2016-11-30
Posted: 2016-12-30
Terminated: 2017-12-13
Recalling firm: Boston Scientific Corporation
Product: Boston Scientific, INGEVITY" MRI Leads, Sterile EO, RxOnly.
Product code: LWP Implantable Pulse Generator, Pacemaker (Non-Crt)
Reason for recall: Boston Scientific is conducting a recall on Boston Scientific INGEVITY" MRI endocardial pacing leads. There is a possibility that the polyurethane boot at the terminal end of the lead was not securely connected to the lead body.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Boston Scientific sent an "Important Medical Device Information" letter dated November 30, 2016. The letter was addressed to "Dear Doctor". The letter described the problem and the product involved in the recall. The letter also described the "Clinical Considerations, Recommendations, Affected Population & Further Information". For questions contact your local Boston Scientific representative or Technical Services. For further questions, please call ( 651) 582-4000.
Quantity in commerce: 15 (2 US; 13 OUS)
Distribution: Worldwide Distribution - US Distribution to the states of : IA and NY., and to the countries of : United Kingdom, Netherlands, Italy, Germany and Belgium.
Product codes and lots: Model 7740 S/N 633464, 610662. Model 7741 S/N 657588, 563539, 628198, 636545, 641593, 656713, 656904. Model 7742 S/N 572200, 584869, 631202. Model 7732 S/N 488740. Model 7736 S/N 631322, 632188.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0938-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0938-2017	Class II	Terminated	Voluntary: Firm initiated	2017-01-11	2016-12-30

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)