REPLY and ESPRIT PACEMAKERS (2016-09-30)

Starting date:

September 30, 2016

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

Hospitals, General Public, Healthcare Professionals

Identification number:

RA-60584

• Reason
• Affected products

Affected Products

1. REPLY SR PACEMAKER
2. REPLY DR PACEMAKER
3. ESPRIT DR PACEMAKER
4. ESPRIT SR PACEMAKER
5. REPLY 200 DR PACEMAKER
6. REPLY 200 SR PACEMAKER

Reason

When an implanted device approaches the recommended replacement time (RRT), the residual longevity estimate provided by the programmer at follow-up may be overestimated, which could result in reaching RRT between two follow-up visits. Until a new programmer software version is approved, LivaNova is providing a number of patient management recommendations.

Affected products