Implantable defibrillator recalled for manufacturing defect causing device failure risk
Medtronic is recalling five implantable defibrillators due to a manufacturing defect where weld cracks caused devices to fail quality testing. The defective devices were identified during manufacturing and did not reach patients.
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 involving a critical cardiac device with a documented manufacturing defect (weld crack) that caused device failures. Although no illnesses or injuries have been reported and the defective devices were identified during manufacturing quality control before reaching patients, the potential for device malfunction in a life-critical application presents a significant risk of harm.
Plain-English summary
Medtronic Inc. is recalling five units of the Cobalt XT DR MRI SureScan, Model Number DDPA2D1, Implantable Cardioverter Defibrillator due to a manufacturing defect. The recall affects devices distributed in 14 U.S. states and multiple international locations.
A weld crack in the device caused failures during the leak check step of manufacturing quality control. These defective devices were identified and removed from production before reaching patients.
The affected device serial numbers are RSL607245S, RSL607881S, RSL607883S, RSL607884S, and RSL607888S. Patients and healthcare providers with affected devices should contact Medtronic for guidance on device replacement or management options. The FDA has classified this as a Class II recall.
The recalled product
- Product
- Cobalt XT DR MRI SureScan, Model Number DDPA2D1, Implantable Cardioverter Defibrillator
- Manufacturer
- Medtronic Inc.
- Affected units
- 5
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 (6)
- GTIN: 00763000178338
- Serial Numbers: RSL607245S
- RSL607881S
- RSL607883S
- RSL607884S
- RSL607888S.
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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