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Boston Scientific CRM Corp

Complete recall history across all FDA and CPSC categories — 8 total recalls

Boston Scientific CRM Corp appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (8)

FDA medical device enforcement actions by Boston Scientific CRM Corp

Date Product Reason Class
Sep 17, 2014 Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E11... Boston Scientific identified a subset of COGNISTM CRT-Ds and TELIGENTM ICDs t... Class II
Sep 17, 2014 Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillat... Boston Scientific identified a subset of COGNISTM CRT-Ds and TELIGENTM ICDs t... Class II
Jun 19, 2014 Boston Scientific ENDOTAK RELIANCE¿ SG, transvenous defibrillation lead, Mode... A review of manufacturing test records for Boston Scientific ENDOTAK RELIANC... Class II
Aug 29, 2013 Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillat... The performance of a low voltage capacitor in a subset of COGNIS CRT-Ds and T... Class II
Aug 29, 2013 Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E11... The performance of a low voltage capacitor in a subset of COGNIS CRT-Ds and T... Class II
Jul 15, 2013 Boston Scientific, ENERGEN DR ICD, Model E143. The device is an Implantable C... Boston Scientific CRM manufacturing quality system recently discovered test a... Class II
Apr 10, 2013 LATITUDE¿ Patient Management System, Model 6488, Version 7.3. The LATITUDE... Boston Scientific CRM is conducting a recall on the LATITUDE Patient Manageme... Class II
Mar 1, 2013 Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generato... An internal protective fuse can be unintentionally activated while the device... Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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