CLASS II Device recall · Reported 20 Apr 2016 · FDA Enforcement Report
PT Graphix Magnet J-tip Guidewire recalled by Boston Scientific
Boston Scientific is recalling Boston Scientific, PT Graphix Magnet J-tip Guidewire with ICE Hydrophilic Coating, distributed nationwide in the US. The recall was initiated on 28 Mar 2016 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1370-2016
- FDA event ID
- 73719
- Recalling firm
- Boston Scientific, Maple Grove, MN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 28 Mar 2016
- FDA classified
- 12 Apr 2016
- Reported
- 20 Apr 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Heart & Vascular Devices
Timeline
| 28 Mar 2016 | Recall initiated by company | |
| 12 Apr 2016 | Classified by FDA | +15 days |
| 20 Apr 2016 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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.
Where it was distributed
US nationwide in the states of ME, LA, and TN
Questions about this recall
Is PT Graphix Magnet J-tip Guidewire with ICE Hydrophilic Coating, Sterile EO, UPN recalled?
Yes. Boston Scientific recalled PT Graphix Magnet J-tip Guidewire with ICE Hydrophilic Coating, Sterile EO, UPN on 28 Mar 2016. The recall is Class II and its status is Terminated. Recall number Z-1370-2016.
Why was it 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
Which lots are affected?
Lot: 17971870
Where was it sold?
US nationwide in the states of ME, LA, and TN
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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