The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-2017-2021·Announced 2021-07-21

VITALIO DR EL Pacemakers Recalled Due to Battery-Related Device Resets

Boston Scientific is recalling VITALIO DR EL pacemakers with Extended Life batteries due to a latent battery condition that may cause unexpected device resets and Safety Mode activation later in device life.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: This is an FDA Class I recall, which requires a minimum severity score of 4 per the rubric. Although no deaths or hospitalizations have been reported, the device malfunction risk and mandatory replacement justify the Severe rating.

Plain-English summary

Boston Scientific Corporation is recalling specific models of VITALIO DR EL dual-chamber pacemakers and cardiac resynchronization therapy pacemakers equipped with Extended Life batteries. The recall affects approximately 16,525 units distributed worldwide.

These devices may develop a latent battery condition characterized by high internal impedance that can emerge later in the device's operational life, even before the device battery indicator signals replacement is needed. The high internal impedance may trigger unexpected system resets during telemetry attempts and cause the device to activate Safety Mode to maintain backup pacing.

When in Safety Mode, the device continues to provide pacing therapy but in a limited capacity. Healthcare providers should contact Boston Scientific or consult recall documentation to identify affected devices based on model and serial numbers and plan for device replacement. No deaths or injuries have been reported in relation to this condition.

Patients with these pacemakers should contact their healthcare provider to determine if their device is included in this recall and discuss appropriate follow-up or replacement.

The recalled product

Product
VITALIO DR EL (pacemaker), Model Numbers: a) J274 b) J277 c) K274 (added 7/15/2021) d) K277 (added 7/15/2021) e) K284 (added 7/15/2021) f) K287 (added 7/15/2021)
Manufacturer
Boston Scientific Corporation
Category
Medical Device — Pacemaker
Hazard
Affected units
16,525

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 (20)

  • a) J274
  • Serial Numbers: 100000
  • 100001
  • 100005
  • 100008
  • 100009
  • 100010
  • 100016
  • 100017
  • 100019
  • 100021
  • 100026
  • 100028
  • 100031
  • 100032
  • 100033
  • 100034
  • 100036
  • 100037
  • 100038

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 6 recalled by Boston Scientific Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 6 products in this recall →

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