—#144806

Product

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.

FDA product code: DQX — Wire, Guide, Catheter
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K143587
Affected lot / code info: Lot: 17971870

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

Root cause (FDA determination)

Process control

Action the firm took

Boston Scientific sent an "Urgent Medical Device Recall" letter dated March 28, 2016. The letter was addressed to Cath Lab Materials Manager / Field Action Contact. The letter described the problem and the product affected by the recall. Advised consignees to cease immediately further distribution or use of the product and to notify their customers. They also requested consignees to complete and return "The Reply Verification Tracking Form" For questions contact your local Boston scientific sales Representative of the Boston Scientific Filed Action Center..

Recalling firm

Firm: Boston Scientific Corporation
Address: 2 Scimed Pl, Maple Grove, Minnesota 55311-1565

Distribution

Distribution pattern: US nationwide in the states of ME, LA, and TN

Timeline

Recall initiated: 2016-03-28
Terminated: 2016-11-07
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #144806. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.