Z-1370-2016Class II

Boston Scientific, PT Graphix Magnet J-TIP Guidewire with ICE Hydrophilic Coating, Sterile EO, UPN...

Name: Z-1370-2016 Boston Scientific, PT Graphix Magnet J-TIP Guidewire with ICE Hydrophilic Coating, Sterile EO, UPN...
Creator: Boston Scientific Corporation
Published: 2016-03-28
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2016-03-28 / Terminated / root cause: manufacturing process

FDA source

Boston Scientific Corporation began a recall of Boston Scientific, PT Graphix Magnet J-TIP Guidewire with ICE Hydrophilic Coating, Sterile EO, UPN H7491490201MJ2 (Carton Label) ,H7491490201MJo (UPN... on 2016-03-28. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1370-2016
Classification: Class II
Status: Terminated
Initiated: 2016-03-28
Posted: 2016-04-12
Terminated: 2016-11-07
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 wire. The proximal section of the PT Graphix Magnet Guidewire is coated with a fluorinated polymer.
Product code: DQX Wire, Guide, Catheter
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
Root cause tag: manufacturing process
FDA root cause: Process control
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..
Quantity in commerce: 47 units
Distribution: US nationwide in the states of ME, LA, and TN
Product codes and lots: Lot: 17971870

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1370-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1370-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-20	2016-04-12

Product code DQX

K143587Class IIChoICE Guide Wire, Mailman Guide Wire, Luge Guide Wire, ChoICE PT Guide Wire, PT Graphix WireBoston Scientific Corporation / cleared 2015-01-15

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)