Medtronic Archer Super Stiff Guidewires Recalled for Potential Kinking and Breaking
Medtronic is recalling specific Archer Super Stiff Guidewires due to a manufacturing defect that may cause the device to kink or break during use.
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 medical device with a structural defect (kinking/breaking) that poses a risk of harm during in-vivo use, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Medtronic Inc. Cardiac Rhythm Disease Management is recalling 27,682 units of the Medtronic Archer 0.035 inch (0.89mm) Super Stiff Guidewire, Models ARCSJ200W, ARCSJ260W, and ARCDJ260W. The recall covers devices distributed worldwide, including the United States, Puerto Rico, and numerous international markets.
The recall was initiated because a change in the manufacturing process was identified as the cause for potential kinking and breaking at the proximal weld end of the outer spring coil during in-vivo use. These guidewires are intended to facilitate catheter placement and exchange during diagnostic or interventional procedures in the aorta.
Healthcare providers and facilities should check their inventory for the specific lot numbers listed in the recall notice. Patients who have had these devices implanted should contact their healthcare provider for guidance on monitoring or further evaluation.
The recalled product
- Product
- Medtronic Archer 0.035 inch (0.89mm) Super Stiff Guidewire, Models ARCSJ200W, ARCSJ260W, and ARCDJ260W. Sterile using ethylene oxide. Product Usage: The Medtronic Archer 0.035 inch (0.89mm) Super Stiff Guidewires are intended to facilitate catheter placement and exchange…
- Manufacturer
- Medtronic Inc. Cardiac Rhythm Disease Management
- Affected units
- 27,682
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)
- Model ARCSJ200W Lot Numbers: GFWC1124
- GFWC1506
- GFWC2138
- GFWC2652
- GFWC2653
- GFWD0353
- GFWD0881
- GFWD0882
- GFWD2048
- GFWD2049
- GFWD2050
- GFWD2051
- GFWD2052
- GFWE0743
- GFWE0744
- GFWE0745
- GFWE0746
- GFWE0747
- GFWE3710
- GFWE4272
Distribution
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