Reported Apr 20, 2016 · Terminated
Boston Scientific, PT Graphix Magnet J-TIP Guidewire with ICE Hydrophilic Coating, Sterile EO, UPN H7491490201MJ2…
Boston Scientific Corporation
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: Boston Scientific Corporation · 2 Scimed Pl · Maple Grove, MN · 55311-1565
Is this the product you have?
- Boston Scientific, PT Graphix Magnet J-TIP Guidewire with ICE Hydrophilic Coating, Sterile EO, UPN H7491490201MJ2 (Carton Label) ,H7491490201MJo (UPN referenced on the Pouch Label) . Boston Scientific PT Graphix Magnet Guidewire with ICE Hydrophilic Coating is a steerable guidewire available with a nominal diameter of 0.014 in (0.37 mm) and in nominal lengths of 182 cm. PT Graphix Magnet is available with a shapeable Straight Tip or a preformed "J"¿ Tip. The PT Graphix Magnet Guidewire features a 10 or 38 cm polymer sleeve, coated with ICE Hydrophilic Coating, jacketing the distal tapered core wire. The proximal section of the PT Graphix Magnet Guidewire is coated with a fluorinated polymer.
- Lot codes and dates
- Lot17971870
- Amount recalled
- 47 units
Where it was sold
Why it was recalled
Boston Scientific is voluntarily implementing a Medical Device Recall of one batch of PT Graphix Magnet J-TIP Guidewires. Boston Scientific has found that, while the batch is labeled as a J-tip model, the guidewires are straight and do not have the pre-formed J-tip. The most severe injury expected to occur is a limited procedure delay caused by the need to replace the guidewire with one that has
This product could cause temporary or reversible health problems — stop using it.
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