Reported Dec 1, 2021 · Ongoing
Medtronic CareLink SmartSync Device Manager application software (D00U005) used by the following Medtronic Cobalt and…
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · 8200 Coral Sea St Ne · Mounds View, MN · 55112-4391
Is this the product you have?
12 of 12 products
| # | Product as published |
|---|---|
| 1 | Medtronic CareLink SmartSync Device Manager application software (D00U005) used by the following Medtronic Cobalt and Crome implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds): Cobalt XT VR: DVPA2D1, DVPA2D4 |
| 2 | Cobalt VR: DVPB3D1, DVPB3D4 |
| 3 | Cobalt XT DR: DDPA2D1, DPA2D4 |
| 4 | Cobalt DR: DDPB3D1, DDPB3D4 |
| 5 | Cobalt XT HF: DTPA2D4, DTPA2D1 |
| 6 | Cobalt XT HF |
| 7 | Quad: DTPA2QQ, DTPA2Q1 |
| 8 | Cobalt HF: DTPB2D4, DTPB2D1 |
| 9 | Cobalt HF Quad: DTPB2QQ, DTPB2Q1. Crome VR: DVPC3D1, DVPC3D4 |
| 10 | Crome DR: DDPC3D1, DDPC3D4 |
| 11 | Crome HF: DTPC2D4, DTPC2D1 |
| 12 | Crome HF Quad: DTPC2QQ, DTPC2Q1. |
- Lot codes and dates
- Application software lower than v5.0.0.
- Amount recalled
- 18,715 devices
Where it was sold
- Nationwide
- PR
Why it was recalled
The processing of collected episode data may fail due to a software error.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Medtronic Inc., Cardiac Rhythm and Heart… recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.