Z-0906-05

Ventak PRIZM 2 DR, model 1861 Automatic Implantable Cardioverter Defibrillator (AICD), Dual Chamber...

Name: Z-0906-05 Ventak PRIZM 2 DR, model 1861 Automatic Implantable Cardioverter Defibrillator (AICD), Dual Chamber...
Creator: Guidant Corporation
Published: 2005-06-17
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2005-06-17 / Terminated

FDA source

Guidant Corporation began a recall of Ventak PRIZM 2 DR, model 1861 Automatic Implantable Cardioverter Defibrillator (AICD), Dual Chamber, Sterilized with gaseous ethylene oxide. Guidant... on 2005-06-17. The reason FDA records is "Laboratory analysis of returned devices revealed that deterioration in a wire insulator within the lead connector block, in conjuction with other factors, resulted in an electrical short. The short caused diversion of...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0906-05
Status: Terminated
Initiated: 2005-06-17
Posted: 2005-06-30
Terminated: 2007-01-05
Recalling firm: Boston Scientific Corporation
Product: Ventak PRIZM 2 DR, model 1861 Automatic Implantable Cardioverter Defibrillator (AICD), Dual Chamber, Sterilized with gaseous ethylene oxide. Guidant Corporation, Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. VENTAK PRIZM 2 ICDs are designed to detect and terminate ventricular tachycardia (VT) and ventricular fibrillation (VF) and provide bradycardia therapy.
Product code: KRG Programmer, Pacemaker
Reason for recall: Laboratory analysis of returned devices revealed that deterioration in a wire insulator within the lead connector block, in conjuction with other factors, resulted in an electrical short. The short caused diversion of shock therapy energy away from the heart and into device circuitry.
FDA root cause: Other
Action: Dear Doctor letter, dated 05/23/05, was sent to doctors 05/23/05 making them aware of 26 random component failures including one death. Doctors were advised to continue normal monitoring of all patients as indicated in device labeling. Press Release was also issued 05/25/05. Another Dear Doctor letter was dated and issued on 06/17/05. This letter provided updated information to the 05/23/05 letter. The letter gave some indications of device failure and recommendations for normal patient monitoring on routine follow-up visits. Another press release was also issued on 06/17/05.
Quantity in commerce: 38,362 (Approx. 24,000 are currently implanted worldwide)
Distribution: Worldwide. Including United States and countries such as: Arab Emirates, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, Cyprus, Czechoslovakia, Denmark, Finland, France, Germany, Hong Kong, Iceland, Ireland, Israel, Italy, Jordan, Kuwait, Lebanon, Luxembourg, Malaysia, Mexico, Monaco, Netherlands, New Zealand, Norway, Panama, Polynesia, Portugal, Saudi Arabia, Singapore, Slovakia, Spain, Sweden, Switzerland, Thailand, Turkey, United Kingdom, Uruguay, Venezuela
Product codes and lots: Serial number range 118626 - 243772 includes ICDs manufactured prior to November 13, 2002. This range includes all affected devices but may include some unaffected devices.

Product code KRG

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)