CLASS II ONGOING Device recall · Reported 12 May 2021 · FDA Enforcement Report

Implantable Pulse Generators recalled by Medtronic Inc., Cardiac

Medtronic Inc., Cardiac Rhythm and Heart Failure (Crhf) is recalling Implantable Pulse Generators. The recall was initiated on 6 Apr 2021 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesall codes

Quantity recalled575815 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1525-2021
FDA event ID: 87662
Recalling firm: Medtronic Inc., Cardiac Rhythm and Heart Failure (Crhf), Mounds View, MN
Classification: Class II
Status: Ongoing
Recall initiated: 6 Apr 2021
FDA classified: 4 May 2021
Reported: 12 May 2021
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Pacemakers & Defibrillators

Timeline

6 Apr 2021	Recall initiated by company
4 May 2021	Classified by FDA	+28 days
12 May 2021	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

A longevity estimation error may occur in the early years of device life when a unipolar pacing vector is programmed in the right atrial (RA) lead and/or the right ventricular (RV) lead. No other device features or therapies are impacted.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

Implantable Pulse Generators - Product Usage: used to treat arrhythmias related to bradycardia. Additionally, CRT-P devices can also provide cardiac resynchronization therapy (CRT) in treatment of heart failure. 1. Azure family: Azure XT DR MRI SureScan", Azure S DR MRI SureScan, Azure XT SR MRI SureScan, Azure S SR MRI SureScan. 2. Astra family: Astra XT DR MRI SureScan, Astra XT SR MRI SureScan.

Where it was distributed

Worldwide distribution.

Questions about this recall

Why was it recalled?

Which lots are affected?

all codes

Where was it sold?

Worldwide distribution.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

3 other products · FDA event 87662

This product is part of a recall event; the main page for the event is CareLink SmartSync Device Manager recalled by Medtronic Inc., Cardiac.

Reported	Class	Recall	Company	Reason	Where
12 May 2021	CLASS II	CareLink SmartSync Device Manager recalled by Medtronic Inc., Cardiac	Medtronic Inc., Cardiac Rhythm and Heart Failure (Crhf)	Device Malfunction	MN
12 May 2021	CLASS II	Programmers - Product Usage: used to treat arrhythmias related recalled	Medtronic Inc., Cardiac Rhythm and Heart Failure (Crhf)	Device Malfunction	MN
12 May 2021	CLASS II	Implantable cardiac resynchronization therapy pacemakers (Crt-p) recalled	Medtronic Inc., Cardiac Rhythm and Heart Failure (Crhf)	Device Malfunction	MN

More recalls from Medtronic Inc., Cardiac Rhythm and Heart Failure (Crhf)

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28 Jun 2023Device	CLASS I	Crt-d Dtbb2q1 Viva Quad S Is4/df1 Intl recalled	Medtronic Inc., Cardiac Rhythm and Heart Failure (Crhf)	Foreign Material	Nationwide
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28 Jun 2023Device	CLASS I	Icd Cobalt Vr Mri Is1 Df1 recalled by Medtronic Inc., Cardiac	Medtronic Inc., Cardiac Rhythm and Heart Failure (Crhf)	Foreign Material	Nationwide
28 Jun 2023Device	CLASS I	Icd-vr Dvab1d4 Visia Af Us Df4 recalled by Medtronic Inc., Cardiac	Medtronic Inc., Cardiac Rhythm and Heart Failure (Crhf)	Foreign Material	Nationwide

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