Boston Scientific Corporation Recall: Boston Scientific, PT Graphix Magnet J-TIP Guidewire
Boston Scientific Corporation Recall: Boston Scientific, PT Graphix Magnet J-TIP Guidewire is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Boston Scientific Corporation; Product: Boston Scientific, PT Graphix Magnet J-TIP Guidewire with ICE Hydrophilic Coating, Sterile EO, UPN H7491490
| Recalling firm | Boston Scientific Corporation |
|---|---|
| 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 |
| 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 |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Terminated |
| Distribution | US nationwide in the states of ME, LA, and TN |
| Recall initiated | 20160328 |
| Recall number | Z-1370-2016 |
| Category | device |
| State | MN |
| Country | United States |
$29/mo
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