Food, drugs, devices › Boston Scientific CRM Corp
Device recall: Boston Scientific ENDOTAK RELIANCE¿ SG, transvenous defibrillation lead, Models 0180 & 0292, Sterile EO. Product Usage:
Boston Scientific CRM Corp (Saint Paul, MN) initiated this device recall on 19 Jun 2014; FDA lists 1 product record under event 68700, classified Class II.
FDA defines Class II as 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. 91% of the 1,176 device enforcement events initiated in 2014 carry the same class.
Status: Terminated, terminated 3 Dec 2014. Initiation: voluntary: firm initiated. Boston Scientific CRM Corp has 6 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Boston Scientific CRM Corp, Saint Paul, MN.
Reason for recall
"A review of manufacturing test records for Boston Scientific ENDOTAK RELIANCE implantable leads revealed a suspected test data recording error. Specifically, some test results were recorded as "failed" without any other indication of failure. There are no reported injuries from the devices."
Distribution
"Worldwide Distribution -US (nationwide) in the states of OH, MN and country of France"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2147-2014 | 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 defibrillator (AICD) systems. | 21 | Class II | Terminated | 13 Aug 2014 |
Context
Other enforcement events for Boston Scientific CRM Corp
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 17 Sep 2014 | Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models | Device | Class II | 2 |
| 29 Aug 2013 | Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models | Device | Class II | 2 |
| 15 Jul 2013 | Boston Scientific, ENERGEN DR ICD, Model E143. The device is an Implantable Cardioverter Defibrillator. | Device | Class II | 1 |
| 10 Apr 2013 | LATITUDE¿ Patient Management System, Model 6488, Version 7.3. The LATITUDE Patient Management system is intended for use | Device | Class II | 1 |
| 1 Mar 2013 | Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide | Device | Class II | 1 |
All 6 events for Boston Scientific CRM Corp
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "A review of manufacturing test records for Boston Scientific ENDOTAK RELIANCE implantable leads revealed a suspected test data recording error. Specifically, some test results were recorded as "failed" without any other indication of failure. There are no reported injuries from the devices."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. 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.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide Distribution -US (nationwide) in the states of OH, MN and country of France"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 3 Dec 2014. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.