Implantable Cardioverter Defibrillator Recalled Due to Manufacturing Weld Defect
Medtronic is recalling 26 MIRRO MRI DR SureScan Implantable Cardioverter Defibrillators due to a manufacturing defect involving a weld crack that could affect device function.
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 an FDA Class II recall of a high-risk implanted cardiac device with no reported illnesses or injuries. The manufacturing defect (weld crack) poses potential risk of device failure, meeting the rubric criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Medtronic Inc. is recalling 26 units of the MIRRO MRI DR SureScan Implantable Cardioverter Defibrillator, Model DDME3D4. The devices have a manufacturing defect involving a weld crack discovered during quality control testing.
The weld crack caused the affected devices to fail the leak check step during manufacturing. A weld crack could compromise the device's structural integrity and its ability to deliver therapy.
The recalled devices are distributed worldwide, including in multiple U.S. states and international countries. Patients with affected devices should contact Medtronic or their healthcare provider regarding evaluation or replacement.
The recalled product
- Product
- MIRRO MRI DR SureScan, Model Number DDME3D4, Implantable Cardioverter Defibrillator
- Manufacturer
- Medtronic Inc.
- Affected units
- 26
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 (20)
- GTIN: 00763000611941
- Serial Numbers: CWT611927S
- CWT611929S
- CWT611932S
- CWT611933S
- CWT611934S
- CWT611935S
- CWT611936S
- CWT611937S
- CWT611938S
- CWT611939S
- CWT611940S
- CWT611941S
- CWT611950S
- CWT611951S
- CWT612011S
- CWT612012S
- CWT612013S
- CWT612014S
- CWT612015S
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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