Z-0938-2017 Class II Terminated
FDA device recall Z-0938-2017 was initiated by Boston Scientific Corporation on Nov 30, 2016 and is designated Class II. 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… The recall status is terminated (terminated Dec 13, 2017). Affected quantity: 15 (2 US; 13 OUS).
Recall Details
- Product Type
- Devices
- Report Date
- Jan 11, 2017
- Initiation Date
- Nov 30, 2016
- Termination Date
- Dec 13, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 15 (2 US; 13 OUS)
Product Description
Boston Scientific, INGEVITY" MRI Leads, Sterile EO, RxOnly.
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.
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.
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.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0938-2017
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026