Boston Scientific Recalls INGEVITY MRI Pacing Leads Due to Connection Defect
Boston Scientific is recalling INGEVITY MRI endocardial pacing leads because the polyurethane boot may not be securely connected to the lead body.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the source describes a risk-of-harm product defect (insecure connection) without reporting specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Boston Scientific Corporation is conducting a recall of INGEVITY MRI endocardial pacing leads. The recall is due to a possibility that the polyurethane boot at the terminal end of the lead was not securely connected to the lead body.
The affected products are sterile, ethylene oxide (EO) sterilized, and prescription-only (RxOnly). The recall involves 15 units, with 2 distributed in the United States and 13 distributed outside the US. US distribution was limited to the states of Iowa and New York. International distribution included the United Kingdom, Netherlands, Italy, Germany, and Belgium.
The specific affected units are identified by the following model and serial numbers: 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); and Model 7736 (S/N 631322, 632188). Healthcare providers and patients should contact Boston Scientific for further instructions regarding the recall.
The recalled product
- Product
- Boston Scientific, INGEVITY" MRI Leads, Sterile EO, RxOnly.
- Manufacturer
- Boston Scientific Corporation
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (11)
- 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
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