The Recall Desk
HighFDA (Devices)·Z-0282-2022·Announced 2021-12-01

Medtronic Cardiac Device Software Affected by Data Processing Error

Medtronic is recalling software used in certain cardiac implant devices due to a data processing error that may fail to collect episode data. Approximately 18,715 devices are affected worldwide.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall of a life-critical cardiac device. Although no illnesses or injuries have been reported, the software error presents a risk of harm by potentially failing to process critical cardiac device data. Per the rubric, risk-of-harm products where injury has not yet been reported receive a High severity rating.

Plain-English summary

Medtronic Inc. is recalling the CareLink SmartSync Device Manager application software (version lower than v5.0.0) used with certain Cobalt and Crome implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds). A software error may cause the processing of collected episode data to fail, potentially affecting the clinical information available for device management.

Approximately 18,715 devices are affected. Distribution includes the United States, military and government facilities, and the following countries: Andorra, Australia, Austria, Belgium, Brunei Darussalam, Canada, Czech Republic, Denmark, Finland, France, French Guiana, French Polynesia, Germany, Greece, Guadeloupe, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Kuwait, Liechtenstein, Luxembourg, Martinique, Netherlands, New Caledonia, New Zealand, Norway, Poland, Portugal, Puerto Rico, Reunion, Romania, Saudi Arabia, Singapore, Slovakia, Spain, Sweden, Switzerland, United Arab Emirates, and United Kingdom.

Patients and healthcare providers should update the software to version v5.0.0 or higher. Contact Medtronic for update instructions and support. Healthcare providers should identify affected patients and schedule timely software updates.

The recalled product

Product
Medtronic CareLink SmartSync Device Manager application software (D00U005) used by the following Medtronic Cobalt and Crome implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds): Cobalt XT VR: DVPA2D1, DVPA2D4; Cobalt VR:
Manufacturer
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Category
Medical Device — Cardiac Implant Device Software
Hazard
  • software-error
  • data-processing-failure

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Application software lower than v5.0.0.

Distribution

Distributed nationwide across the United States.

Related recalls

Same category