Manufacturer

Boston Scientific CRM Corp

8 recalls in our database name Boston Scientific CRM Corp as the manufacturing or recalling firm.

What the numbers show

Total: 8
Critical: 0
Severe: 1
Most recent: 2014-10-29

Of the 8 recalls from Boston Scientific CRM Corp we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (13%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–8 of 8

HighFDA (Devices)·Z-0087-2015·2014-10-29
Boston Scientific COGNIS CRT-D Recall for Premature Battery Depletion
Boston Scientific is recalling COGNIS CRT-Ds and TELIGENT ICDs due to a capacitor defect that may cause the battery to deplete prematurely.
Product
Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Product Usage: Boston Scientific cardiac resynchronization
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0088-2015·2014-10-29
Boston Scientific TELIGEN ICDs Recalled for Premature Battery Depletion
Boston Scientific is recalling TELIGEN ICDs and COGNIS CRT-Ds due to a capacitor defect that may cause the battery to deplete prematurely.
Product
Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models E103, E111, F102, F103, F110, F111. Sterilized using ethylene oxide. Product Usage: This family of implantable cardioverter defibrillator
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2147-2014·2014-08-13
Boston Scientific recalls 21 ENDOTAK RELIANCE defibrillation leads due to test errors
Boston Scientific is recalling 21 ENDOTAK RELIANCE defibrillation leads because manufacturing test records showed suspected data recording errors. No injuries have been reported.
Product
Boston Scientific ENDOTAK RELIANCE¿ SG, transvenous defibrillation lead, Models 0180 & 0292, Sterile EO. Product Usage: The ENDOTAK RELIANCE leads provide pacing and rate-sensing and deliver cardioversion and defibrillation shocks for automatic implantable cardioverter defibr
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0026-2014·2013-10-23
Boston Scientific TELIGEN ICDs Recalled for Premature Battery Depletion Risk
Boston Scientific is recalling TELIGEN implantable cardiac defibrillators because a capacitor defect may cause premature battery depletion.
Product
Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0025-2014·2013-10-23
Boston Scientific COGNIS CRT-D Recall for Premature Battery Depletion
Boston Scientific is recalling COGNIS CRT-D devices because a capacitor defect may cause premature battery depletion.
Product
Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1979-2013·2013-08-28
Boston Scientific Recalls ENERGEN DR ICD Due to Test Artifacts
Boston Scientific is recalling one ENERGEN DR ICD (Model E143) because test artifacts related to shock charge time require further investigation.
Product
Boston Scientific, ENERGEN DR ICD, Model E143. The device is an Implantable Cardioverter Defibrillator.
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-1339-2013·2013-05-29
Boston Scientific Recalls LATITUDE Patient Management System Software
Boston Scientific is recalling the LATITUDE Patient Management System software because a system update caused clinic faxes to display illegible characters instead of required patient information.
Product
LATITUDE¿ Patient Management System, Model 6488, Version 7.3. The LATITUDE Patient Management system is intended for use to remotely communicate with a compatible Boston Scientific pulse generator and transfer data to a central database.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0965-2013·2013-03-27
Boston Scientific SQ-RX Subcutaneous Pulse Generators Recalled for Fuse Activation
Boston Scientific is recalling SQ-RX Model 1010 subcutaneous pulse generators because an internal fuse may activate unintentionally, preventing the device from delivering therapy.
Product
Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias.
Category
Medical Device
Distribution
17 states