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U.S. Department of Health and Human Services

Class 2 Device Recall Guidant ASSURE ICD

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  Class 2 Device Recall Guidant ASSURE ICD see related information
Date Initiated by Firm March 16, 2007
Date Posted November 24, 2007
Recall Status1 Terminated 3 on November 23, 2007
Recall Number Z-0049-2008
Recall Event ID 44793
Product Classification Implantable Cardioverter Defibrillator, ICD. - Product Code LWP
Product Guidant ASSURE, Model B301, Implantable Cardioverter Defibrillator, ICD. (This model is not available in the USA) Guidant Corporation Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 55112-5798, USA.
Code Information Model B301: B301/100002, B301/100003, B301/100004, B301/100006, B301/100007, B301/100008, B301/100010, B301/100012, B301/100013, B301/100014, B301/100016, B301/100019, B301/100020, B301/100021, B301/100022, B301/100024, B301/100025, B301/100027, B301/100030, B301/100031, B301/100032, B301/100034, B301/100037, B301/100039, B301/100043, B301/100044, B301/100045, B301/100046, B301/100048, B301/100050, B301/100051, B301/100053, B301/100054, B301/100056, B301/100062, B301/100063, B301/100064, B301/100067, B301/100069, B301/100070, B301/100073, B301/100074, B301/100075, B301/100076, B301/100079, B301/100080, B301/100081, B301/100082, B301/100083, B301/100084, B301/100087, B301/100088, B301/100089, B301/100090, B301/100091, B301/100092, B301/100094, B301/100096, B301/100099, B301/100100, B301/100101, B301/100102, B301/100103, B301/100104, B301/100105, B301/100106, B301/100108, B301/100111, B301/100112, B301/100113, B301/100114, B301/100115, B301/100116, B301/100117, B301/100118, B301/100120, B301/100122, B301/100125, B301/100126, B301/100128, B301/100129, B301/100130, B301/100131, B301/100132, B301/100134, B301/100135, B301/100136, B301/100137, B301/100139, B301/100140, B301/100141, B301/100142, B301/100143, B301/100144, B301/100145, B301/100146, B301/100147, B301/100148, B301/100149, B301/100153, B301/100154, B301/100155, B301/100158, B301/100159, B301/100161, B301/100162, B301/100164, B301/100165, B301/100166, B301/100167, B301/100169, B301/100170, B301/100172, B301/100173, B301/100174, B301/100176, B301/100180, B301/100181, B301/100182, B301/100183, B301/100185, B301/100186, B301/100187, B301/100188, B301/100189, B301/100191, B301/100193, B301/100194, B301/100195, B301/100196, B301/100197, B301/100200, B301/100203, B301/100204, B301/100205, B301/100206, B301/100208, B301/100209, B301/100210, B301/100211, B301/100213, B301/100215, B301/100216, B301/100218, B301/100221, B301/100222, B301/100223, B301/100224, B301/100226, B301/100227, B301/100230, B301/100234, B301/100235, B301/100236, B301/100238, B301/100239, B301/100242, B301/100243, B301/100244, B301/100245, B301/100247, B301/100249, B301/100253, B301/100255, B301/100258, B301/100260, B301/100264, B301/100271, B301/100272, B301/100273, B301/100279, B301/100280, B301/100285, B301/100288, B301/100290, B301/100293, B301/100298, B301/100315, B301/100317, B301/100318  
Recalling Firm/
Manufacturer		 Boston Scientific CRM Corp
4100 Hamline Ave N
Saint Paul MN 55112-5700
Manufacturer Reason
for Recall		 Atypical Charge Time Behavior: 1)-End of Life (EOL) or ERI is displayed during mid-life (typically 24-48 months), even though battery capacity remains available. 2)- Extended ERI charge time limits: Charge times during mid-life may remain below a normal extension of the ERI charge time . ****** Prophylactic replacement of these devices prior to ERI is not recommended. As stated in the Product
FDA Determined
Cause 2		 Device Design
Action A Product Update titled "ERI Charge Time Limit Extended During Mid-Life and Mid-Life Display of Replacement Indicators", dated 03/10/2007 was posted to Company's website on 03/13/2007. A CRM Product News letter was sent to physicians beginning 03/16/2007. The CRM Product News Letter gave an overview of the content of the Product Update and stated the web location for finding the complete Product Update. The Product Update identified affected devices, gave an overview of normal charge time behavior at mid-life for specific ICD and CRT-D devices. The letter also described the atypical charge time behavior, projected rate of mid-life display of replacement indicators and Patient Management Considerations. ****** Prophylactic replacement of these devices prior to ERI is not recommended. As stated in the Product Update, "Devices that have triggered charge time-based ERI or EOL during mid-life have several months, and in most cases more than one year of remaining battery voltage and capacity, which allows the devices in this pattern to continue to provide brady and LV pacing and maximum energy shocks. However, if ERI or EOL is triggered, device replacement should be scheduled."*****Recalled units only cover devices implanted prior to July 2005****
Quantity in Commerce 180-Recalled units only cover devices implanted prior to July 2005
Distribution Worldwide
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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