CONTAK RENEWAL 3 RF (models H210, H215), CONTAK RENEWAL 3… recallZ-0863-06 · Guidant Corporation · initiated Mar 11, 2006
Terminated All recalls posted in May 2006
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Guidant Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Guidant received 39 reports of devices that exhibited lower than expected battery voltage prior to implant; none of these devices were implanted.
FDA root cause category: Other
What the company is doing
Affected physicians were sent an Urgent Medical Device Safety Information & Corrective Action letter, dated 05/11/06. A press release was issued March 13, 2006 The letter describes the issue and emphasizes the importance of checking battery voltage prior to implant as stated in device labeling. For implanted devices, continue normal follow-up.
Recall details
- Recall number
- Z-0863-06
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Mar 11, 2006
- Posted by the FDA
- May 16, 2006
- Recalling firm
- Guidant Corporation
- Quantity
- 8,879
- Product code
- NIK
- FDA submissions
- P010012
- Distribution
- Nationwide, Puerto Rico, Virgin Islands and to countries that include: Austria, Belgium, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Iran, Ireland, Israel, Italy, Luxembourg, Mexico, Netherlands, Norway, Portugal, Saudi Arabia, Slovakia, Spain, Sweden, Switzerland, United Arab Emirates, United Kingdom
Product description
CONTAK RENEWAL 3 RF (models H210, H215), CONTAK RENEWAL 3 RF HE (models H217, H219), CONTAK RENEWAL 4 RF (models H230, H235) CONTAK RENEWAL 4 RF HE (model H239) cardiac resynchronization therapy defibrillator (CRT-D), provide ventricular tachyarrhythmia and cardiac resynchronization therapies. Ventricular tachyarrhythmia therapy is for the treatment of ventricualar tachycardia (VT) and ventricular fibrillation (VF), rhythms that are associated with suden cardiac death (SCD). Cardiac resynchronization therapy is for the treatment of heart failure (HF) and uses biventricular electrical stimulation to synchronize ventricular contractions. The device also uses accelerometer-based adaptive-rate bradycardia therapy. These CONTAK RENEWAL RF devices feature enhanced telemetry communication with wandless ZIP telemetry. Cardioversion/defibrillation therapies include a range of low- and high-energy shocks using either a biphasic or monophasic waveform. Guidant Corporation, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA.
Code information (models, lots, serial numbers)
Issue affecting devices is a pre-implant issue. Serial number ranges listed below may also include devices not affected (i.e. implanted devices). Model H210 serial number 200031 thru 202462. Model H215 serial numbers 700016 thru 702646. Model H217 serial numbers 700006 thru 702543. Model H219 serial numbers 200021 thru 201747. Model H230 serial numbers 100012 thru 200526. Model H235 serial numbers 100018 thru 650559. Model H239 serial numbers 100018 thru 650272.
Other devices under the same FDA submission
50 devices cleared under P010012 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- VIGILANT™ X4 CRT-D G247Boston Scientific Corporation · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)17 deaths2,066 reports
- ACUITY™ X4 Spiral S 4674Boston Scientific Corporation · Implantable pulse generator, pacemaker (non-CRT)16 deaths1,975 reports
- ACUITY™ X4 Straight 4671Boston Scientific Corporation · Implantable pulse generator, pacemaker (non-CRT)5 deaths1,875 reports
- INOGEN™ X4 CRT-D G148Boston Scientific Corporation · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)8 deaths1,252 reports
- RESONATE™ X4 CRT-D G447Boston Scientific Corporation · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)13 deaths1,218 reports
- DYNAGEN™ X4 CRT-D G158Boston Scientific Corporation · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)13 deaths1,166 reports
- MOMENTUM™ CRT-D G125Boston Scientific Corporation · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)4 deaths792 reports
- MOMENTUM™ CRT-D G124Boston Scientific Corporation · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)5 deaths790 reports
- ACUITY™ X4 Spiral L 4677Boston Scientific Corporation · Implantable pulse generator, pacemaker (non-CRT)2 deaths729 reports
- EASYTRAK® 2 IS-1 4543Boston Scientific Corporation · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)5 deaths727 reports
- RESONATE™ HF CRT-D G547Boston Scientific Corporation · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)1 death542 reports
- EASYTRAK® 2 IS-1 4542Boston Scientific Corporation · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)3 deaths536 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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