CLASS II ONGOING Device recall · Reported 3 Jul 2024 · FDA Enforcement Report

Cobalt DR MRI SureScan recalled by Medtronic

Medtronic is recalling Cobalt DR MRI SureScan, distributed nationwide in the US. The recall was initiated on 16 Apr 2024 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesGTIN: 00763000178406, Serial Numbers: RSO618526S, RSO618555S, RSO618559S; GTIN: 00763000711313, Serial Numbers: RSO618395S, RSO618396S, RSO618399S, RSO618400S, RSO618401S, RSO618402S, RSO618403S, RSO618405S, RSO618408S, RSO618409S, RSO618410S, RSO618412S, RSO618415S, RSO618416S, RSO618417S, RSO618419S, RSO618420S, RSO618421S, RSO618422S, RSO618439S, RSO618440S, RSO618443S, RSO618444S, RSO618580S, RSO618581S, RSO618582S, RSO618585S, RSO618586S, RSO618587S, RSO618588S, RSO618589S, RSO618590S, RSO618593S.

Quantity recalled36 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-2207-2024
FDA event ID: 94674
Recalling firm: Medtronic, Mounds View, MN
Classification: Class II
Status: Ongoing
Recall initiated: 16 Apr 2024
FDA classified: 26 Jun 2024
Reported: 3 Jul 2024
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Packaging Defects
Device type: Pacemakers & Defibrillators

Timeline

16 Apr 2024	Recall initiated by company
26 Jun 2024	Classified by FDA	+71 days
3 Jul 2024	Published in enforcement report	+7 days

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

Reason for recall

Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

COBALT DR MRI SureScan, Model Number DDPB3D4, Implantable Cardioverter Defibrillator

Where it was distributed

Worldwide - US Nationwide distribution in the states of CA, CT, FL, IN, MA, MI, NC, NH, NJ, NM, NY, OH, TX, VA and the countries of Australia, Austria, Bulgaria, Canada, China, Croatia, Czech Republic, France, Georgia, Germany, Greece, Guadeloupe, Iceland, Ireland, Italy, Jordan, Kosovo, Latvia, Moldova, Republic Of, Netherlands, Northern Ireland, Norway, Oman, Panama, Poland, Portugal, Qatar, Reunion, Slovakia, Slovenia, Spain, Sweden, Switzerland, United Arab Emirates, United Kingdom.

Nationwide California Connecticut Florida Georgia Indiana Massachusetts Michigan North Carolina New Hampshire New Jersey New Mexico New York Ohio Texas Virginia

Questions about this recall

Is Cobalt DR MRI SureScan recalled?

Yes. Medtronic recalled Cobalt DR MRI SureScan on 16 Apr 2024. The recall is Class II and its status is Ongoing. Recall number Z-2207-2024.

Why was it recalled?

Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.

Which lots are affected?

GTIN: 00763000178406, Serial Numbers: RSO618526S, RSO618555S, RSO618559S; GTIN: 00763000711313, Serial Numbers: RSO618395S, RSO618396S, RSO618399S, RSO618400S, RSO618401S, RSO618402S, RSO618403S, RSO618405S, RSO618408S, RSO618409S, RSO618410S, RSO618412S, RSO618415S, RSO618416S, RSO618417S, RSO618419S, RSO618420S, RSO618421S, RSO618422S, RSO618439S, RSO618440S, RSO618443S, RSO618444S, RSO618580S, RSO618581S, RSO618582S, RSO618585S, RSO618586S, RSO618587S, RSO618588S, RSO618589S, RSO618590S, RSO618593S.

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

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