Health product recall

Medtronic Adapta Pacing System (Adapta, Sensia, Attesta) (2019-01-14)

Starting date:
January 14, 2019
Posting date:
January 30, 2019
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type I
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-68958

Affected Products

  1. Adapta
  2. Sensia
  3. Attesta

Reason

Devices in the affected subset, when programmed to a dual chamber mode with atrial-sensing, may experience a circuit error that affects device functionality. For this error to occur, a unique combination of events must take place while the device is processing an atrial-sensed event. If this error occurs, the device will be unable to provide pacing until a ventricular-sensed event (VS) is detected. Once a VS is detected, normal pacing functionality is restored immediately. If a VS is not detected, the device will withhold both atrial and ventricular pacing. In addition, until a VS is detected, the device will be unable to initiate a session with a programmer, initiate a session with a CareLink Remote Monitor, or respond to a magnet. Single chamber and dual chamber pacing modes that do not sense atrial activity are not susceptible to this circuit error.

Affected products

A. Adapta

Lot or serial number

More than 10 numbers, contact manufacturer

Model or catalog number
  • ADDR01
  • ADDR03
  • ADDRL1
  • ADVDD01
Companies
Manufacturer
Medtronic Inc.
710 Medtronic Parkway
Minneapolis, Minnesota
55432
UNITED STATES

B. Sensia

Lot or serial number

More than 10 numbers, contact manufacturer

Model or catalog number
  • SEDR01
  • SEDRL1
Companies
Manufacturer
Medtronic Inc.
710 Medtronic Parkway
Minneapolis, Minnesota
55432
UNITED STATES

C. Attesta

Lot or serial number

More than 10 numbers, contact manufacturer

Model or catalog number

ATDRL1

Companies
Manufacturer
Medtronic Inc.
710 Medtronic Parkway
Minneapolis, Minnesota
55432
UNITED STATES