Z-2211-2024Class II
CROME VR MRI SureScan, Model Number DVPC3D1, Implantable Cardioverter Defibrillator
Medtronic, Inc. / initiated 2024-04-16 / Open, Classified / root cause: manufacturing process
Medtronic Inc. began a recall of CROME VR MRI SureScan, Model Number DVPC3D1, Implantable Cardioverter Defibrillator on . FDA classified it as Class II and gives the reason as "Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing". As of , the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.
Recall record
- Recall number
- Z-2211-2024
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- Medtronic, Inc.
- Product
- CROME VR MRI SureScan, Model Number DVPC3D1, Implantable Cardioverter Defibrillator
- Product code
- LWS Implantable Cardioverter Defibrillator (Non-Crt)
- Reason for recall
- Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
- Root cause tag
- manufacturing process
- FDA root cause
- Nonconforming Material/Component
- Action
- On about 04/18/2024, Medtronic notified customers that they were retrieving distributed units that may have undergone a specific manufacturing sequence that requires additional engineering evaluation. They requested that customers acknowledge the letter with signature.
- Quantity in commerce
- 9 units
- Distribution
- 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.
- Product codes and lots
- GTIN: 00763000178543, Serial Numbers: RSG601442S, RSG601443S, RSG601445S, RSG601446S, RSG601449S, RSG601461S, RSG601467S, RSG601478S; GTIN: 00763000711382, Serial Number: RSG601428S.
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-2190-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2191-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2192-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2193-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2194-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2195-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2196-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2197-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2198-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2199-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2200-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2201-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2202-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2203-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2204-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2205-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2206-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2207-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2208-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2209-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2210-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2211-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2212-2024 | Class II | Ongoing | Voluntary: Firm initiated |
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