Class II — Boston Scientific Corporation
| Recalling firm | Boston Scientific Corporation |
|---|---|
| Registered facility | View this company's 37 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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 |
| 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 tapere… |
| Quantity | 47 units |
| Distribution | US nationwide in the states of ME, LA, and TN |
| Initiated | 2016-03-28 |
| Classified | 2016-04-12 |
| Terminated | 2016-11-07 |
| Recall number | Z-1370-2016 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Boston Scientific Corporation (Z-1370-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/73719/
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