The Recall Desk
HighFDA (Devices)·Z-2548-2017·Announced 2017-06-21

Medtronic Recalls Pacemaker Angio X3 Due to Potential Seal Defect

Medtronic is recalling 478,465 units of the Pacemaker Angio X3 because an incomplete seal on the inner package may cause the suture material to degrade prematurely.

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: The recall is classified as FDA Class II and involves a risk-of-harm product (medical device) where injury has not yet been reported, which aligns with the 'High' severity criteria in the rubric.

Plain-English summary

Medtronic is recalling the Pacemaker Angio X3 (Item Number: 4045255423347) due to a potential defect in the inner package seal. The recall covers 478,465 units distributed worldwide, including the United States (including Puerto Rico) and countries such as Australia, Belgium, Canada, Chile, China, Israel, Italy, Japan, South Korea, Mexico, Panama, Saudi Arabia, Singapore, and Turkey.

The identified issue is a potential for an incomplete seal on the inner package. This defect may result in the premature degradation of the suture material contained within the device. The source text does not report any specific illnesses, injuries, or deaths associated with this defect.

Healthcare providers and consumers should contact Medtronic or their local distributor for instructions on how to handle the recalled units. The recall is classified as Class II by the FDA, indicating a situation where use of the product could, in some cases, cause temporary or medically reversible health consequences.

The recalled product

Product
SCHRITTMACHER ANGIO X3; Item Number: 4045255423347
Manufacturer
Medtronic
Category
Medical Device — Cardiac Pacemaker Accessories
Hazard
Affected units
478,465

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)

  • 228111X

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 8 recalled by Medtronic 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 8 products in this recall →

Related recalls

Same manufacturer · Medtronic

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Same hazard · packaging defect

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