Medtronic PRIMO MRI DR SureScan Cardioverter Defibrillators Recalled for Manufacturing Defect
Medtronic is recalling two PRIMO MRI DR SureScan implantable cardioverter defibrillators due to a potential manufacturing defect involving weld cracks detected during manufacturing quality testing.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: This is a Class II recall of a risk-of-harm product (implantable cardioverter defibrillator) where the manufacturing defect creates potential for serious device failure. No illnesses or injuries have been reported, and the defect was caught during manufacturing quality testing before patient implantation.
Plain-English summary
Medtronic Inc. is recalling two units of the PRIMO MRI DR SureScan, Model DDMD3D1, implantable cardioverter defibrillator (ICD) due to a potential manufacturing defect.
The defect involves a weld crack that caused the affected devices to fail leak check testing during the manufacturing process, before distribution to patients. The two affected units are identified by Serial Numbers CWM605634S and CWM605635S.
These devices were distributed worldwide to healthcare facilities in the United States (California, Connecticut, Florida, Indiana, Massachusetts, Michigan, North Carolina, New Hampshire, New Jersey, New Mexico, New York, Ohio, Texas, Virginia), as well as to Australia, Austria, Bulgaria, Canada, China, Croatia, Czech Republic, France, Georgia, Germany, Greece, Guadeloupe, Iceland, Ireland, Italy, Jordan, Kosovo, Latvia, Moldova, Netherlands, Northern Ireland, Norway, Oman, Panama, Poland, Portugal, Qatar, Reunion, Slovakia, Slovenia, Spain, Sweden, Switzerland, United Arab Emirates, and the United Kingdom.
Patients or healthcare providers who have received either affected device should contact Medtronic for guidance. Healthcare facilities should secure the recalled devices and follow the manufacturer's instructions regarding replacement or device retrieval.
The recalled product
- Product
- PRIMO MRI DR SureScan, Model Number DDMD3D1, Implantable Cardioverter Defibrillator
- Manufacturer
- Medtronic Inc.
- Affected units
- 2
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 (3)
- GTIN: 00763000611910
- Serial Numbers: CWM605634S
- CWM605635S.
Distribution
Part of a larger recall action
This product is one of 23 recalled by Medtronic Inc. 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.
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