Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 75813

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
November 30, 2016
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Boston Scientific Corporation

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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

Z-0938-2017
Recall number
Z-0938-2017
Initiated
November 30, 2016
Classification
Class II
Status
Terminated
Quantity
15 (2 US; 13 OUS)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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.

Distribution pattern

Worldwide Distribution - US Distribution to the states of : IA and NY., and to the countries of : United Kingdom, Netherlands, Italy, Germany and Belgium.