Z-0049-2008

Guidant ASSURE, Model B301, Implantable Cardioverter Defibrillator, ICD. (This model is not available in the...

Name: Z-0049-2008 Guidant ASSURE, Model B301, Implantable Cardioverter Defibrillator, ICD. (This model is not available in the...
Creator: Boston Scientific CRM Corp
Published: 2007-03-16
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2007-03-16 / Terminated / root cause: design

FDA source

Boston Scientific CRM Corp began a recall of Guidant ASSURE, Model B301, Implantable Cardioverter Defibrillator, ICD. (This model is not available in the USA) Guidant Corporation Cardiac Rhythm... on 2007-03-16. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0049-2008
Status: Terminated
Initiated: 2007-03-16
Posted: 2007-11-24
Terminated: 2007-11-23
Recalling firm: Boston Scientific Corporation
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.
Product code: LWP Implantable Pulse Generator, Pacemaker (Non-Crt)
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
Root cause tag: design
FDA root cause: 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
Product codes and lots: 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

Product code LWP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)