Medtronic Achieve Electrical Cables Recalled for Potential Sterility Breach
Medtronic is recalling 64 units of Achieve Electrical Cables (Model 990066) due to a potential sterility breach. The sterile, single-use cables were distributed to facilities in 16 states and DC.
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: The recall involves a potential sterility breach in a sterile, single-use medical device, which poses a risk of infection. No illnesses or injuries are reported in the source text, and the agency classification is Class II, aligning with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Medtronic Inc. is recalling 64 units of Achieve Electrical Cables, Model 990066, due to a potential sterility breach. These sterile, single-use electrical cables provide conduction elements from the proximal end of the Achieve Catheter handle to standard shielded ECG pins. The cables are used with the Medtronic Ablation Frontiers Achieve Mapping Catheter for electrophysiological mapping of cardiac structures.
The affected units, identified by Lot U531, were distributed to facilities in the District of Columbia and the states of Arkansas, California, Colorado, Delaware, Georgia, Iowa, Kentucky, Maine, Michigan, Minnesota, New York, Ohio, Pennsylvania, Tennessee, Texas, and Virginia.
Healthcare facilities should stop using the affected cables and contact Medtronic for instructions on return or replacement. Patients who have used these devices should contact their healthcare provider if they experience any signs of infection or other adverse effects.
The recalled product
- Product
- Medtronic Achieve Cables, model 990066. The sterile, single use only Electrical Cable (Model 990066) provides the conduction elements from the proximal end of the Achieve Catheter handle to standard shielded ECG pins that connect into standard electrophysiology recording and…
- Manufacturer
- Medtronic Inc.
- Affected units
- 64
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 (1)
- Lot U531
Distribution
Related recalls
Same manufacturer · Medtronic Inc.
See all →- HighMedtronic Sphere-9 Catheter may cause ventricular fibrillation with Biotronik ICDs
FDA (Devices) · 2026-05-06
- HighVenous stents recalled over a nitinol anomaly that reduces deployed diameter
FDA (Devices) · 2026-01-21
- ModerateKidney tests recalled for distribution without premarket approval or clearance
FDA (Devices) · 2025-12-10
- HighSmartSync Patient Connector limited the window to abort high voltage therapy
FDA (Devices) · 2025-07-30
- HighCareLink SmartSync limited the window to abort a high voltage therapy
FDA (Devices) · 2025-07-30
Same hazard · sterility breach
See all →- HighMedline Open Heart A Pack Kits Recalled for Sterility Concerns
FDA (Devices) · 2026-09-23
- HighAVID Medical Recalls Halyard IV Start Kits Due to Seal Defects
FDA (Devices) · 2026-09-16
- SevereMedline Ultrasound Breast Pack Recalled for Potential Sterility Breach
FDA (Devices) · 2026-09-09
- SevereMedline C-Section Prep Kits Recalled for Potential Sterility Breach
FDA (Devices) · 2026-09-09
- HighMedline Convenience Kits Recalled for Potential Sterility Breach
FDA (Devices) · 2026-09-09
Similar recalls
- HighStryker Recalls Reprocessed Electrophysiology Catheter Cables Due to Sterility Breach
FDA (Devices) · 2017-01-18
- ModerateMedtronic Recalls Single-Use Disposable Devices Due to Sterility Control Issues
FDA (Devices) · 2014-11-26
- HighMedtronic cardiac catheter system recalled due to sterility barrier defect
FDA (Devices) · 2022-06-08
- HighMedtronic Disposable Gloves Recalled for Sterility Compromise
FDA (Devices) · 2017-03-08
- HighMedtronic Recalls Single-Use Navigation Devices Due to Sterility Control Issues
FDA (Devices) · 2014-11-26
- HighMedtronic Recalls Valleylab Laparoscopic Electrodes Due to Sterile Barrier Risk
FDA (Devices) · 2016-08-24