Z-0269-2007

Guidant CONTAK RENEWAL 3 RF (models H210, H215), CONTAK RENEWAL 3 RF HE (models H217, H219) ,CONTAK RENEWAL 4...

Name: Z-0269-2007 Guidant CONTAK RENEWAL 3 RF (models H210, H215), CONTAK RENEWAL 3 RF HE (models H217, H219) ,CONTAK RENEWAL 4...
Creator: Guidant Corporation
Published: 2006-09-30
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2006-09-30 / Terminated

FDA source

Guidant Corporation began a recall of Guidant CONTAK RENEWAL 3 RF (models H210, H215), CONTAK RENEWAL 3 RF HE (models H217, H219) ,CONTAK RENEWAL 4 RF (model H230), and CONTAK RENEWAL 4 RF HE... on 2006-09-30. The reason FDA records is "Shock Effectiveness: there is a potential for malfunction of a high voltage wire, which could compromise effectiveness of shock therapy. While no energy is lost, defibrillation thresholds may be higher (and safety...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0269-2007
Status: Terminated
Initiated: 2006-09-30
Posted: 2006-12-16
Terminated: 2007-04-01
Recalling firm: Boston Scientific Corporation
Product: Guidant CONTAK RENEWAL 3 RF (models H210, H215), CONTAK RENEWAL 3 RF HE (models H217, H219) ,CONTAK RENEWAL 4 RF (model H230), and CONTAK RENEWAL 4 RF HE (model H239) cardiac resynchronization therapy defibrillator (CRT-D). Guidant Corporation, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA.
Product code: LWP Implantable Pulse Generator, Pacemaker (Non-Crt)
Reason for recall: Shock Effectiveness: there is a potential for malfunction of a high voltage wire, which could compromise effectiveness of shock therapy. While no energy is lost, defibrillation thresholds may be higher (and safety margin may be reduced) because the shocking vector has changed.
FDA root cause: Other
Action: An Important Medical Device Information letter, dated 10/09/2006 was sent to physicians following patients with a potentially affected device. The letter describes the issue, provides for a projected rate of occurrence, and provides recommendations. An October 9, 2006 Product Advisory Letter, beginning October 30, 2006, was also sent to provide an update that further laboratory testing and analysis indicates that the nominal probability of malfunction is higher than their earlier prediction. Non-implanted devices have been retrieved.
Quantity in commerce: 57 (46-USA, 11 Foreign- Renewal 4RF)
Distribution: Worldwide distribution ---- including states of CA, FL, GA, IA, IL, KY, MA, MO, NJ, NY, OH, PA, TX and countries of Italy, Netherlands, Sweden, United Kingdom.
Product codes and lots: Model H210, serial numbers: 204765, 204766, 204767, 204769, 204770, 204771, 204772, 204773, 204774, 204777, 204784, 205492, 205494, 205495, 205497, 205498, 205504, 205507, 205512, 205523, 205525. Model H215, serial numbers: 703984, 703985, 703986, 704415, 704417, 704418, 704421, 704422, 704423, 704424, 704425. Model H217, serial numbers: 704509, 704531, 704534, 704545, 704547, 704550, 705267, 705294, 705335, 705350. Model H219, serial numbers: 203320, 203344, 203355, 203377, 203382. Model H230, serial numbers: 201149, 201150, 201151, 201152, 201153, 201154, 201155. Model H239, serial numbers: 650451, 650453, 650454.

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)