High FDA (Devices)·Z-1019-2013·Announced 2013-04-03

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.

What this means for you

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
Category: Medical Device — Cardiac Guidewire
Hazard: structural-failure
device-breakage
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

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Same manufacturer · Medtronic Inc. Cardiac Rhythm Disease Management

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