Z-1440-2010

Medtronic EnRhythm, P1501DR, Dual Chamber Rate Responsive Pacemaker with RapidRead Telemetry. The EnRhythm...

Name: Z-1440-2010 Medtronic EnRhythm, P1501DR, Dual Chamber Rate Responsive Pacemaker with RapidRead Telemetry. The EnRhythm...
Creator: Medtronic Inc. Cardiac Rhythm Disease Managment
Published: 2010-02-11
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2010-02-11 / Terminated / root cause: manufacturing process

FDA source

Medtronic Inc. Cardiac Rhythm Disease Managment began a recall of Medtronic EnRhythm, P1501DR, Dual Chamber Rate Responsive Pacemaker with RapidRead Telemetry. The EnRhythm pacing system is an implantable medical device that... on 2010-02-11. The reason FDA records is "Medtronic is informing doctors of two specific battery issues with EnRhythm pacemakers that will be addressed by a Medtronic software update available mid-2010. If the software update referenced above is not...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1440-2010
Status: Terminated
Initiated: 2010-02-11
Posted: 2010-04-26
Terminated: 2013-01-08
Recalling firm: Medtronic, Inc.
Product: Medtronic EnRhythm, P1501DR, Dual Chamber Rate Responsive Pacemaker with RapidRead Telemetry. The EnRhythm pacing system is an implantable medical device that monitors, detects, and treats atrial tachyarrhythmia episodes. It also provides bradycardia pacing and monitoring of ventricular tachycardia (VT) episodes. Manufactured at: Juncos, Puerto Rico, USA. Medtronic, Inc., Minneapolis, MN 55432 USA.
Product code: DXY Implantable Pacemaker Pulse-Generator
Reason for recall: Medtronic is informing doctors of two specific battery issues with EnRhythm pacemakers that will be addressed by a Medtronic software update available mid-2010. If the software update referenced above is not implemented, there will be a potential risk of loss of device functionality or risk for loss of therapy at or near ERI in a small number of devices. The software will eliminate this issue, fo
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Consignees were given a Medtronic "Important : Medical Device Correction" letter addressed to "Dear Doctor" and dated February 2010. In the letter, Medtronic is informing doctors of two specific battery issues with EnRhythm pacemakers that will be addressed by a Medtronic software update available mid-2010. The letter included recommendations including that Medtronic recommends physicians continue to use the ERI notification to determine time for device replacement. At this time, no other action, reprogramming or change in the frequency of follow-up is recommended. For additional information or assistance, please contact your local Medtronic Representative or Medtronic Technical Services at 800-505-4636.
Quantity in commerce: approximately 120,061 worldwide
Distribution: All States in the USA including Guam, Puerto Rico and DC. OUS: Customers in the following countries: Andorra, Argentina, Aruba, Australia, Austria, Bangladesh, Belarus, Belgium, Brazil, Brunei, Darussalam, Canada, Cayman Islands, Chile, China, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, Germany, Greece, Guam, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kenya, Kuwait, Latvia, Lebanon, Luxembourg, Malaysia, Malta, Mexico, Morocco, Netherlands, New Caledonia, New Zealand, Norway, Pakistan, Panama, Philippines, Poland, Portugal, Qatar, Romania, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Turkey, United Arab Emirates, United Kingdom, Vatican City, Venezuela, Viet Nam, Virgin Islands
Product codes and lots: All EnRhythm pacemakers

Product code DXY

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)