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Terminated

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 Recall Z-1370-2016 · Posted None

Recalling FirmBoston Scientific Corporation
Recall StatusTerminated
Product CodeDQX
Date Initiated2016-03-28
Date Terminated2016-11-07
Product Quantity47 units

Reason for Recall

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

Firm Action

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..

Root Cause

Process control

Distribution Pattern

US nationwide in the states of ME, LA, and TN

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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