CLASS II Device recall · Reported 12 Jan 2022 · FDA Enforcement Report

Instructions for Use for all recalled by Medtronic Inc., Cardiac

Medtronic Inc., Cardiac Rhythm and Heart Failure (Crhf) is recalling Instructions for Use for all, distributed nationwide in the US. The recall was initiated on 19 Nov 2021 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesThe IFU for all model numbers and serial numbers.

Quantity recalled21,653 devices

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-0464-2022
FDA event ID: 89140
Recalling firm: Medtronic Inc., Cardiac Rhythm and Heart Failure (Crhf), Mounds View, MN
Classification: Class II
Status: Terminated
Recall initiated: 19 Nov 2021
FDA classified: 6 Jan 2022
Reported: 12 Jan 2022
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Heart & Vascular Devices

Timeline

19 Nov 2021	Recall initiated by company
6 Jan 2022	Classified by FDA	+48 days
12 Jan 2022	Published in enforcement report	+6 days

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

Reason for recall

There have been reports of stent migration.

Product as listed by the FDA

Instructions for Use for all model numbers of the Medtronic Abre Venous Self-Expanding Stent System.

Where it was distributed

Distribution was nationwide. There was also military/government distribution. Foreign distribution was made to Argentina, Australia, Austria, Bahrain, Belgium, Botswana, Bulgaria, Canary Islands, Chile, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Guatemala, Hong Kong, India, Ireland, Israel, Italy, Jordan, Kenya, Lithuania, Malaysia, Republic of Moldova, Netherlands, New Zealand, Nicaragua, Norway, Oman, Peru, Poland, Portugal, Russian Federation, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, Ukraine, United Arab Emirates, United Kingdom, United States, Uruguay, and Viet Nam,

Nationwide

Questions about this recall

Why was it recalled?

There have been reports of stent migration.

Which lots are affected?

The IFU for all model numbers and serial numbers.

Where was it sold?

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.

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

All 136

Reported	Class	Recall	Company	Reason	Where
28 Jun 2023Device	CLASS I	Crt-d Dtba2d4 Viva Xt Is1/df4 Intl recalled by Medtronic Inc., Cardiac	Medtronic Inc., Cardiac Rhythm and Heart Failure (Crhf)	Foreign Material	Nationwide
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
28 Jun 2023Device	CLASS I	Crtd Dtpa2d1g Cobalt Xt Hf Quad Ous recalled by Medtronic Inc., Cardiac	Medtronic Inc., Cardiac Rhythm and Heart Failure (Crhf)	Foreign Material	Nationwide
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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All 6,199

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16 Sep 2026Device	CLASS II	Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled	Atrium Medical	Potency & Assay	Nationwide
16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes: *Bardex¿ I.C recalled	C.R. Bard	Other	Nationwide
16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes recalled by C.R. Bard	C.R. Bard	Other	Nationwide
16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes recalled by C.R. Bard	C.R. Bard	Other	Nationwide
16 Sep 2026Device	CLASS II	Getinge PVC Thoracic Catheter, Firm PVC Straight recalled	Atrium Medical	Potency & Assay	Nationwide